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Study Objectives This is a phase I dose escalation and expansion study in patients with ER+, HER2- advanced breast cancer to explore the tolerance, PK/PD(pharmacokinetics/pharmacodynamics) profiles and preliminary anti-tumor activity of different doses of LX-039 tablets. The trial consists of two parts, dose escalation and dose expansion. Part 1 is the dose escalation phase with initial 6 dose groups, and "3 + 3" design is used to explore MTD of the drug; Part 2 is the dose expansion phase with 2 \~ 3 doses selected for expansion according to the escalation results of Part 1, and more subjects are enrolled to further observe the tolerance and preliminary anti-tumor activity of the drug. After the completion of dose expansion, the recommended phase II dose (RP2D) will be determined after discussion based on the obtained tolerance and PK/PD data. Conditions: Advanced Breast Cancer Intervention / Treatment: DRUG: LX-039 tablets Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: QUADRUPLE

Inclusion Criteria: * Be able to read and sign the informed consent form. * Adult females (aged ≥18 and ≤75 years). * Be diagnosed with breast cancer confirmed by pathological examination. * Be histologically or cytologically confirmed estrogen receptor positive (ER+≥1% positive staining). * Be postmenopausal. * Subjects who have previously received endocrine therapy and obtained benefit. * ECOG(Eastern Cooperative Oncology Group) score ≤ 1. * Subjects in part2 of the study need to have measurable lesions that meet RECIST 1.1 criteria. * Has recovered from toxicity or injury from prior chemotherapy/radiotherapy . * Enough hematology and organ function. * Expected survival>3 months. Exclusion Criteria: * Subjects with HER2-overexpressing breast cancer. * Subjects with known brain metastases or other central nervous system metastases that are symptomatic or untreated. * Patients with symptomatic advanced disease who have spread to the viscera and are at risk of life-threatening complications. * Subjects who received second-line or above chemotherapy. * Subjects with known allergy to this product or any of its components. * Subjects who previously used other estrogen receptor down regulators than fulvestrant. * Subjects who received endocrine therapy or other anti-tumor agent or radiotherapy within 4 weeks prior to study entry. * Subjects who received cell therapy or tumor vaccine therapy; * Subjects with severe immunosuppression . * Severe or uncontrolled disease. * Subjects with diseases or abnormalities that may affect the administration and absorption of drugs. * Subjects with other malignancy within 5 years prior to study entry. * Subjects with other high risks of thrombosis or require long-term use of antiplatelet drugs. * Subjects with history of definite neurological or psychiatric disorders in the past. * Subjects who are HIV(human immunodeficiency virus) antibody positive, HBsAg(hepatitis B surface antigen) positive or HCV(hepatitis C virus)antibody positive. * Subjects with other uncontrolled malignant/non-malignant diseases, significant laboratory abnormalities, participation in the study may increase the risk.

Study Objectives This is an interdisciplinary study that falls into the Humanitarian Use Device category. There are no hypotheses to be tested in this treatment protocol. The study has the following objectives: 1. Provide supervised access to treatment with TheraSphere® to eligible patients with primary cancer to the liver who are not surgical resection candidates. 2. Evaluate patient experience and toxicities associated with TheraSphere® treatment. 3. Measure tumor response rates Conditions: Liver Tumors, Hepatocellular Carcinoma, Hepatoma, Neoplasms Intervention / Treatment: DEVICE: TheraSphere® Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Confirmed diagnosis of hepatocellular carcinoma. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass with known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP (clinical diagnosis) * Surgical evaluation must conclude the patient is not a candidate for resection or ablation. * ECOG Performance Status Score 0 - 2. * Age 18 years or older. * Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: Any pre-treatment laboratory findings within 15 days of treatment demonstrating: * Absolute granulocyte count less than or equal to 1,500/ul * Uncorrected Platelet count less than or equal to 75,000/ul * Serum creatinine greater than or equal to 3.0 mg/dl * Serum bilirubin greater than or equal to 2.0 mg/dl * Any of the following contraindications to angiography and selective visceral catheterization, 1.)History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine, 2.) Bleeding diathesis, not correctable by usual forms of therapy, and/or 3.) Severe peripheral vascular disease that would preclude catheterization. * Portal hypertension with portal venous shunt away from the liver. * Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either: 1) first TheraSphere® administration; or 2) cumulative delivery of radiation to the lungs > 30 Gy over multiple treatments. * Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow. * Significant extrahepatic disease representing an imminent life-threatening outcome. * Severe liver dysfunction (Childs' Classification C) or pulmonary insufficiency (requiring continuous oxygen therapy). * Active uncontrolled infection * Significant underlying medical or psychiatric illness. * Pregnant women may not participate. * Children may not participate due to lack of clinical experience.

Study Objectives • The objectives of this study are to confirm the medication delivery accuracy of the Infusion System, LLC Implantable Drug Delivery System (IDDS) with Patient Controlled Analgesia for intrathecal delivery of morphine sulfate for pain control, and to determine the safety profile of the system with PCA for intrathecal delivery of morphine sulfate for pain control. Conditions: Cancers, Chronic Pain Intervention / Treatment: DEVICE: Implantation of Morphine Sulfate delivering programmable pump Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Subject must be at least 21 years of age. * Subject must have experienced chronic pain for at least 6 months. * Subject must not presently be on intrathecal therapy but must be considered a candidate for intrathecal analgesia by his pain specialist; or, a subject already on intrathecal therapy must be in need of a replacement intrathecal pump and catheter. * Subject must be capable of giving informed consent. * Subjects who agree to sign a Pain Treatment Agreement (Narcotic Contract) limiting narcotic prescriptions to the study physician. * Subjects who agree to periodic drug testing. * Subject must be capable and willing to follow all study-related procedures, including returning for monthly refills. * Subject must be cognitively intact and, in the opinion of the Investigator, capable of using the Patient Remote. * Subject who is not already successfully treated with intrathecal analgesic therapy must be responsive to a trial of intrathecal or epidural morphine. * Female subjects of child-bearing potential must agree to use a medically acceptable and effective double-barrier method of birth control. * Documented failure to respond to less invasive methods of pain control (such as physical or behavioral modifications). * Ineffective pain control with single or multiple systemic analgesic treatments (oral, rectal, IV or transdermal) or had intolerable side effects. * Cancer pain requiring strong opioids or non-malignant pain with average Visual Analog Scale (VAS) score of ≥ 4/10. * Subjects who can receive an MRI. * Subjects must be able to hear and respond to audible alarms or agree to have a support person available who is able to hear and respond to audible alarms. Exclusion Criteria: * Subject is a female who is pregnant or is planning a pregnancy. * Subject is a nursing mother. * Subject has at the site chosen for implantation a skin condition that would prevent the implantation procedure. * Subject has participated in an investigational drug or device trial within 4 weeks prior to enrollment. * Subject has any known or suspected allergy to morphine or to the materials of the infusion pump or intrathecal catheter. * Subject shows signs of active, systemic infection. * Subject has a known central nervous system contraindication to intrathecal therapy, including but not limited to severe spinal canal stenosis or spinal cord compression. * Subject has a body size that is insufficient to accept the bulk and weight of the pump. * Subject is allergic to morphine sulfate, or for whom morphine sulfate is contraindicated. * Subject has a condition requiring diathermy procedures. * Subject has a life expectancy of less than 9 months. * Subject cannot independently comprehend and participate in the required assessments, including responding to the QOL, BPI, ODI and PGIC measurement tools. * Subject is not considered to be medically or psychologically appropriate for pump implantation. * Subject has a urine drug screen result which indicates the use of prescription drugs or controlled substances not on the order of a physician. * Subjects with an ASA Physical Status >IV. * Subjects with a history of spinal instability, or grade II spondylolisthesis or greater. * Previously implanted subjects with spinal MRI findings of inflammatory mass prior to the implantation procedures. * Subjects who are unable or unwilling to return to all of the required follow-up visits. * Subjects who are unwilling to sign the informed consent. * Subjects who are exposed to high-current industrial equipment (i.e. electricians or electrical engineers) or regularly exposed to MRI equipment (i.e. MRI technicians, MRI engineers and MRI clinicians). * Subjects with active implanted devices such as pacemakers, defibrillators, cochlear implants and neurostimulators or other medical device use that can interfere with the function of the implanted intrathecal pump.

Study Objectives This study aimed to evaluate the feasibility of dual sentinel node staining method using mixture of indocyanine green(ICG) and radioisotope (RI) in breast cancer patients who receive neoadjuvant chemotherapy. Over the past few years, several studies have found using methylene blue, isosulfan blue, indocyanine green or radioisotope alone by detection method had several disadvantages. In this study we expects using mixture of indocyanine green (ICG) with radioisotope (RI) has potential to improve sentinel lymph node (SLN) mapping in breast cancer patients who receive neoadjuvant chemotherapy. Conditions: Breast Cancer Intervention / Treatment: PROCEDURE: sentinel lymph node biopsy(SLNB) Location: Korea, Republic of Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * breast cancer patients who receive neoadjuvant chemotherapy * cN1-cN2 or cT2 on tumor lymphnode metastasis classification(TNM) * ECOG Performance status 0 or 1 * consented patients with more than 20 years, less than 70 years Exclusion Criteria: * history of breast cancer * early stage breast cancer * history of excisional or incisional biopsy or axillary dissection * inflammatory breast carcinoma * cN3 on tumor lymphnode metastasis classification(TNM) * history of hormone therapy or targeted therapy * stage 4 breast cancer * pregnancy

Study Objectives RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, vinblastine, and prednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Surgery to remove involved lymph nodes may be an effective treatment for young patients with nodular lymphocyte-predominant Hodgkin lymphoma. PURPOSE: This phase IV trial is continuing to study the side effects of giving surgery alone or giving surgery with cyclophosphamide, vinblastine, and prednisolone compared with giving cyclophosphamide, vinblastine, and prednisolone alone in treating young patients with stage IA or stage IIA nodular lymphocyte-predominant Hodgkin lymphoma. Conditions: Lymphoma Intervention / Treatment: DRUG: cyclophosphamide, DRUG: prednisolone, DRUG: vinblastine sulfate, OTHER: watchful waiting, PROCEDURE: therapeutic conventional surgery Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion criteria: * nodular lymphocyte-predominant Hodgkin's lymphoma confirmed by reference pathology. * initial stage IA/IIA (according to local staging) or relapse stage IA or IIA and residual tumour after relapse biopsy and no additional surgery planned in nLP patients relapsing after surgery alone * patient aged under 18 years at time of diagnosis * written informed consent of the patient and/or the patient's parents or guardian according to national laws Exclusion criteria * pre-treatment of Hodgkin's lymphoma differing from study protocol * Any extra-nodal involvement * Inability to fulfil protocol requirements for imaging (CT, MRI, FDG-PET) at staging and response assessment * known hypersensitivity or contraindication to study drugs * prior chemotherapy or radiotherapy * Current or recent therapy (within 30 days prior to the start of trial treatment) with steroids * Current or recent (within 30 days prior to the start of trial treatment) treatment with another investigational drug or participation in another investigational trial * other (simultaneous) malignancies * severe concomitant diseases (e.g. immune deficiency syndrome) * known HIV positivity * pregnancy and / or lactation * females who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly or surgical sterile) (except for surgery only)

Study Objectives The purpose of this study is to determine a tolerable dose of radiation delivered by the CyberKnife system in two groups of patients with hepatocellular carcinoma (HCC). Conditions: Liver Neoplasms, Colonic Neoplasms, Metastatic Cancer to Liver Intervention / Treatment: RADIATION: Stereotactic Radiosurgery using the CyberKnife System. Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Hepatocellular carcinoma (as defined by biopsy or alpha-fetoprotein (AFP) greater than 1000ng/dL with appropriate imaging) or liver metastases from colorectal cancer or other tumor (as defined by biopsy or elevated Carcinoembryonic antigen (CEA) or a positive positron emission tomography (PET) scan in conjunction with a mass on CT or MRI in a patient with previously resected cancer). Patients with at least one measurable liver lesion and no more than 3 are eligible if they meet all other eligibility criteria including the dose constraints on the composite plan. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Patients are not candidates for definitive surgical resection because of tumor location, hepatic function, or other medical or personal reasons. * Patients with HCC who are being considered for liver transplant may be entered as a bridge to transplant if it is considered by the transplant team that an ablative therapy would be of value while awaiting transplant. * If cirrhosis is present, patients will have Child-Pugh score of A or B (see Appendix A in the Master Protocol). * Patients will have tumors not optimally treated with radio-frequency ablation by interventional radiology, or by GI/transplant surgery. This could be for reasons of size, tumor location, or other reasons. * Ability to place fiducial markers in the vicinity of the tumor to allow for radiographic tracking of respiratory motion and tumor localization. Fiducial placement will generally be done by interventional radiology. * Estimates of hepatic tolerance must meet the criteria as defined in Section III. This eligibility will not be able to made definitively until the patient has agreed to participate. in the study and the appropriate scan analyses and dosimetry have been performed. No more than one decrement in dose from the planned dose level will be allowed for an individual patient because of exceeding the maximal liver doses before the patient is declared ineligible for study. * Adequate bone marrow and renal function as assessed by the following: * Absolute neutrophil count (ANC) > 1000/mm3 * Platelet count > 80,000/mm3 * Creatinine < 2.0 mg/dL OR Creatinine clearance > 45 mL/min based on Cockcroft-Gault formula). * Patients with extra hepatic metastatic disease are eligible if it is the opinion of the treating physician that local therapy to the liver may produce worthwhile clinical benefits * Patient is able to understand fully the potential risks and benefits of this approach and signs an appropriate informed consent. * Male and female of >18 years of age. Male or female patients capable of reproduction must agree to use medically acceptable methods of contraception, such as an intrauterine device, diaphragm, with spermicide, condom with spermicide or abstinence. Inclusion of females of childbearing potential requires a negative pregnancy test within 14 days prior to study initiation. Exclusion Criteria: * Child-Pugh Class C cirrhosis * Patients with clinically apparent central nervous system (CNS) disease. * Medical or psychiatric illness that would not allow the patient to tolerate the proposed treatment including inability to lie flat for an extended period of time, severe claustrophobia or other reasons. * Uncontrolled or significant cardiovascular disease including: myocardial infarction within 6 months, uncontrolled angina within 6 months, Class III-IV New York Heart Association (NYHA) congestive heart failure, grade 3 cardiac valve dysfunction * Evidence of decompensated liver disease as evidenced by: clinically significant ascites refractory to diuretic therapy) evidence of hepatic encephalopathy, coagulopathy not corrected by conservative measures. * A history of CTCAE Grade 3 bleeding esophageal or gastric varices within the past 2 months. Prior variceal bleed permitted if patient has undergone banding or sclerotherapy and there has been no evidence of bleeding for 2 months. Patients at risk for varices (based on the following: known history of esophageal or gastric varices; evidence of hepatic cirrhosis and/or portal hypertension including biopsy-proven cirrhosis, hypersplenism, or radiographic findings of varices) will be screened for esophageal varices. If varices are identified that require intervention (banding), patient will not be eligible until varices adequately treated. * Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study. * Uncontrolled intercurrent illness. * Inability to comply with study and/or follow-up procedures. * A patient with Child-Pugh Class A will not be eligible for study if the liver dose constraint described in Section 3.2 cannot be met after two decrements in dose per fraction as described above. * A patient with Child-Pugh Class B will not be eligible for study if the liver dose constraint described in Section 3.2 cannot be met after two decrements in dose per fraction as described above.

Study Objectives Objective: To determine activity of combo of Irinotecan + Temozolomide To further characterize any toxicity associated w combo of Irinotecan + Temozolomide Conditions: Glioblastoma Intervention / Treatment: DRUG: Temodar and Irinotecan Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Pts have histologically proven supratentorial GBM * Pts have newly diagnosed disease * There must be measurable disease on contrast-enhanced magnetic resonance imaging performed <14 days before drug administration. Those who underwent resection must have MRI <72 hrs/ >14 days after surgery * Prior Surgical Resection/Biopsy: Although surgical resection is not required, pts must be treated <42 days of surgery or biopsy * Age >18 yrs * Karnofsky Performance Status >70 percent * Serum creatinine < 1.5 x ULN * Absolute neutrophil count >1500 cells/microliter; platelet count >100,000 cells/microliter * Serum SGOT \& total bilirubin <2.5 x ULN * Signed informed consent, approved by IRB, will be obtained prior to initiating treatment * Pts must agree to practice effective birth control measures while on study \& for 2 months after completing therapy Exclusion Criteria: * Pregnant/breast feeding women / women/men w reproductive potential not practicing adequate contraception. This therapy may be associated w potential toxicity to fetus/child that exceeds minimum risks necessary to meet health needs of mother * Active infection requiring intravenous antibiotics * Known diagnosis of HIV infection * Pts w history of another primary malignancy that currently requires active intervention * Pts unwilling/unable to comply w protocol due to serious medical/psychiatric condition * Pts who underwent surgical resection for GBM <2 weeks of start of treatment * Pts who have received prior chemo, biologic therapy, XRT, interstitial brachytherapy/radiosurgery to brain

Study Objectives The purpose of this study is to determine the effect of treatment with guselkumab in participants with familial adenomatous polyposis (FAP) on rectal/pouch polyp burden. Conditions: Adenomatous Polyposis Coli Intervention / Treatment: DRUG: Guselkumab, DRUG: Placebo Location: Spain, United States, Germany, Israel, France, Poland, Netherlands, Puerto Rico, Sweden Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Phenotypic familial adenomatous polyposis (FAP) with disease involvement of the colorectum by either genetic or clinical diagnosis: Adenomatous polyposis coli (APC) germline mutation with or without family history, or with greater than (>)100 adenomas in large intestine and a family history of FAP, attenuated FAP is allowed. FAP phenotype post colectomy for polyposis with a family history of FAP may be allowed * Post-colectomy or subtotal colectomy * Polyps with a sum of diameters greater than or equal to (>=)10 millimeter (mm) in the rectum or pouch on biopsy at screening * A woman of childbearing potential must agree not to get pregnant during the study and at least 12 weeks after the last dose of study administration * A woman must agree not to breast feed or donate eggs (ova, oocytes) during the study and for a period of 12 weeks after the last administration of study drug Exclusion Criteria: * Prior use of any biologic therapy targeting interleukin (IL)-12/23, IL-17, or IL-23 receptor * Use of non-steroidal anti-inflammatory drugs other than aspirin during the study. The use 100 milligram (mg) of aspirin a day or 700 mg of aspirin per week is allowed * Treatment with other FAP-directed drug therapy (including NSAID \[Nonsteroidal anti-inflammatory drug\] drugs), unless completes a 4-week washout period prior to randomization * High grade dysplasia or cancer on biopsy at screening in GI tract (including stomach, duodenum, and colon/rectum/pouch) * Duodenal, colorectal, or pouch polyp: >2 centimeter (cm) unless excised at the screening evaluation; and 1 to 2 cm with evidence of high-grade dysplasia upon biopsy unless excised

Study Objectives To demonstrate whether addition of MM-121 to paclitaxel is more effective than treatment with paclitaxel alone, when administered as part of the neoadjuvant treatment in Her2 negative locally advanced operable breast cancer patients. Conditions: ER Positive, Her2 Negative Breast Cancer Patients, Triple Negative Breast Cancer Patients Intervention / Treatment: DRUG: MM-121, DRUG: Paclitaxel Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histological confirmation of ER positive, HER2 negative invasive breast cancer (Group 1) or invasive triple-negative breast cancer (Group 2) * Free of metastatic disease * ≥ 18 years old * Female * Had no prior treatment for any cancer * Eligible for treatment with paclitaxel, doxorubicin and cyclophosphamide Exclusion Criteria: * Have a history of severe allergic reactions to paclitaxel or other drugs formulated in Cremaphor® EL * Are pregnant or breastfeeding

Study Objectives PROMETEO II is a single-arm window of opportunity trial to evaluate biologic and anti-proliferative effects of palbociclib and letrozole in HR+/HER2-negative operable breast cancer (BC) patients with residual disease after neoadjuvant chemotherapy (NAC) and help to identify biomarkers for better patient selection. Conditions: Breast Cancer Intervention / Treatment: DRUG: Palbociclib, DRUG: Letrozole Location: Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Written and signed informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures. * Female patients age ≥ 18 years. * ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 to 1. * Histologically confirmed non-metastatic primary HR-positive/HER2 negative breast cancer with all the following characteristics: * Breast cancer eligible for surgery. * ER-positive and/or PgR-positive and HER2-negative tumor by the most recent ASCO/CAP guidelines, before neoadjuvant treatment locally assessed. * Ki67% ≥ 5% after neoadjuvant chemotherapy locally assessed (Dowsett M et al JNCI 2011). * A lesion that could be confirmed by ultrasound (US) after neoadjuvant chemotherapy. * Completed ≥80% total dose of an anthracycline/taxane-based neoadjuvant regimen planned. The allowed chemotherapy regimens will be AC (cyclophosphamide, doxorubicin) or EC (epirubicin, cyclophosphamide) 4 cycles followed by weekly paclitaxel x 12 or AC or EC 4 cycles followed by docetaxel 4 cycles. It would be acceptable to change the administration sequence to paclitaxel followed by AC/EC. AC can be given either a standard dose or in a dose-dense schedule. Paclitaxel could be administered as a solvent-based or Nanoparticle albumin-bound (Nab) formulation. * Availability of a recent formalin-fixed paraffin-embedded (FFPE) tumor sample before NAC and a research tumor biopsy after NAC. Minimal sample requirements are to have at least 2 tumor cylinders with a minimal tissue surface of 10 mm2 tissue, containing at least 10% tumor cells and having enough tissue to do at least 2 cuts of 10 μm each. * Adequate organ function determined within 28 days prior to enrollment, defined as follows: * Hematological * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L * Platelet count ≥ 100 x 109/L * Hemoglobin ≥ 9 g/dL (red blood cell transfusion and/or erythropoietin allowed) * Renal * Serum creatinine ≤ 1.5 x upper limit of normal (ULN), or 24-hour creatinine clearance ≥ 60 mL/min for a subject with creatinine levels >1.5 x ULN. (Note: Creatinine clearance does not need to be determined if the baseline serum creatinine is within normal limits. Creatinine clearance should be calculated per institutional standard). * Hepatic * Serum bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for a subject with total bilirubin level > 1.5 x ULN * Aspartate aminotransferase (AST) ≤ 2.5 x ULN * Alanine aminotransferase (ALT) ≤ 2.5 x ULN Coagulation International normalization ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN * Serum or urine pregnancy test must be negative within 7 days prior enrollment in women of childbearing potential. If the urine pregnancy test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before randomization, as determined by local practice, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. Women of childbearing potential enrolled to the treatment must use adequate contraception for the duration of protocol treatment. * Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. * Resolution of all acute toxic effects of prior anti-cancer therapy to NCI CTCAE version 5.0 Grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator´s discretion). * Pre/peri-menopausal and post-menopausal women are allowed; menopausal status is relevant for the requirement of goserelin or triptorelin to be used concomitantly with palbociclib plus letrozole. Post-menopausal status is defined either by: * Prior bilateral oophorectomy or * Age ≥60 or * Age < 60 and amenorrhea for ≥ 12 months prior to the start of neoadjuvant chemotherapy and FSH and estradiol in the post-menopausal range per local standards prior to the start of neoadjuvant chemotherapy. For patients who do not meet the one of the previous parameters, therapy-induced amenorrhea (goserelin or triptorelin), it must have been started more 14 days before the start of palbociclib plus letrozole treatment. Exclusion Criteria: * Non-operable, locally advanced breast cancer (inoperable stage III) after NAC. * Bilateral or metastatic invasive breast cancer at the time of the diagnosis. * Known severe hypersensitivity reactions to compounds similar to palbociclib or to excipients or to endocrine treatments. * History of any previous treatment using Aromatase inhibitors (AI) o selective estrogen receptor modulator (SERMs) in the past 5 years. * Prior therapy with palbociclib or any cyclin-dependent kinase (CDK) inhibitor. * Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to enrollment. * Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A isoenzymes within 7 days of randomization. * Any surgery (not including minor procedures such as primary tumor core biopsy, fine needle aspiration) within 4 weeks of start of study treatment; or not fully recovered from any side effects of previous procedures. * Sentinel lymph node biopsy is not allowed before NAC. * Diagnosis of any previous malignancy within the last 3 years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical carcinoma * Malabsorption syndrome or other condition that would interfere with enteric absorption. * Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis. * Uncontrolled electrolyte disorders (eg, hypocalcemia, hypokalemia, hypomagnesemia). * Any of the following within 6 months of enrollment: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 5.0 Grade ≥2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism. * Corrected QT interval (QTc) greater than 480 msec or a family or personal history of long or short QT syndrome, Brugada syndrome or know history of QTc prolongation, or Torsade de Pointes (TdP). * Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes, or psychiatric illness/social situations that would limit compliance with study requirements. Ability to comply with study requirements is to be assessed by each investigator at the time of screening for study participation.

Study Objectives Non functioning pituitary adenomas (NFPAs) are the most common pituitary adenomas. Their growth is usually slow and diagnosis is often made in the context of masse effect .The therapeutic alternatives are surgery and radiotherapy such as fractionated stereotactic radiotherapy. Nowadays, there is no clinical or histological prognostic factor to allow an individualized follow-up and recurrence could happen 10 or 15 years after the first surgery. In this study, the investigators evaluate NFPAs recurrence rate after surgery and try to find predictive factors of recurrence to personalized the follow-up of each patient. Conditions: Pituitary Adenomas Intervention / Treatment: OTHER: Patients Location: France Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients >18 year-old * diagnosis of NFPAs confirmed with hormonal and histological analysis * patients who underwent surgery in neurosurgery unit of the Reims university hospital between 01/01/1991 and 31/12/2004 Exclusion Criteria: *

Study Objectives This phase II trial is studying how well giving iodine I 131 tositumomab together with etoposide and cyclophosphamide followed by autologous stem cell transplant works in treating patients with relapsed or refractory non-Hodgkin's lymphoma. Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find cancer cells and deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as etoposide and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Combining a radiolabeled monoclonal antibody with combination chemotherapy before autologous stem cell transplant may kill more cancer cells Conditions: Anaplastic Large Cell Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Splenic Marginal Zone Lymphoma, Waldenström Macroglobulinemia Intervention / Treatment: DRUG: cyclophosphamide, DRUG: etoposide, RADIATION: iodine I 131 tositumomab, PROCEDURE: quality-of-life assessment, PROCEDURE: peripheral blood stem cell transplantation Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have a histologically confirmed diagnosis of lymphoma expressing the cluster of differentiation (CD)20 antigen and generally must have failed at least one prior standard systemic therapy; the exception will be mantle cell lymphoma (MCL) patients, who may be enrolled while in first complete remission (CR) in accordance with current transplant standard of care for these patients * Note: Patients with clinically non-transformed follicular lymphomas do not require repeat biopsies for immunophenotyping since these tumors are uniformly reactive with the tositumomab antibody * Patients must have tumor burdens < 500cc by computed tomography (CT) or magnetic resonance (MRI) volumetric measurements and must not have splenomegaly at the time of enrollment; splenomegaly will be defined as a spleen volume > 2 standard deviations of the mean spleen volume to body weight ratio (mean = 3.84 cc/kg, SD = 1.53 cc/kg); thus, patients with > 6.9cc/kg will be defined as having splenomegaly; patients with splenomegaly that is thought to be due to G CSF/GM-CSF effect and not due to lymphomatous involvement of the spleen can been deemed eligible with the approval of an investigator * Patients must have normal renal function (creatinine \[Cr\] < 2.0) * Patients must have normal hepatic function (bilirubin < 1.5mg/dL), with the exception of patients thought to have Gilbert's syndrome, who may have a total bilirubin above 1.5mg/dL * All patients eligible for therapeutic study must have autologous hematopoietic stem cells (2 x 10\^6 CD34+ cells/kg) harvested and cryopreserved * Patients must have an expected survival of > 60 days and must be free of major infection Exclusion Criteria: * Circulating anti-mouse antibody (HAMA) * Systemic anti-lymphoma therapy given within 30 days prior to anticipated treatment date * Inability to understand or give an informed consent * Prior radiation > 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord, or over 25% of red marrow) * Central nervous system lymphoma * Other serious medical conditions considered to represent contraindications to autologous stem cell transplant (ASCT) (e.g., active coronary artery disease, pulmonary dysfunction \[forced expiratory volume in 1 second (FEV1) < 70% expected, Vital Capacity < 70% expected, diffusing capacity of the lung for carbon monoxide (DLCO) < 50%, patient on supplemental oxygen\], AIDS, etc.) * Pregnancy * Prior bone marrow or stem cell transplant * Presence of circulating lymphoma cells by morphology or flow cytometry (>= 0.1%) at or near the time of peripheral blood stem cell (PBSC) collection if unpurged PBSC are to be used * Southwest Oncology Group (SWOG) performance status >= 2.0 * Unable to perform self-care during radiation isolation * Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma/well differentiated lymphocytic lymphoma (ineligible because these tumors express very low surface densities of CD20)

Study Objectives The purpose of this study is to evaluate the anti-tumor effect of sirolimus-based immunosuppressive regimen in patients following living donor liver transplantation for hepatocellular carcinoma exceeding Milan criteria with respect to recurrence-free survival. Conditions: Hepatocellular Carcinoma Intervention / Treatment: DRUG: Sirolimus, DRUG: m-TOR inhibitor free Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria : * Age ≥ 18 yrs and weight ≥ 40 kg. * Histologically proven HCC exceeding Milan criteria before randomization, regardless of the prior therapy * Signed and dated written informed consent * Lack of relevant exclusion criteria * Women who were of childbearing potential must have had a negative qualitative serum pregnancy test before Investigational agent administration and must have agreed to use a medically acceptable method of contraception during treatment period of the study. Exclusion Criteria : * Multiple organ recipients * Deceased donor liver transplant * Known hypersensitivity to Simulect®, sirolimus, tacrolimus, cyclosporine, or MMF or its derivatives * Hyperlipidemia refractory to optimal medical management (cholesterol >300 mg/dl; Triglycerides > 350 mg/dl) * Evidence of significant local or systemic infection at the time of randomization. * Known HIV-positive patients * Women of child-bearing potential not willing to take contraception * Patients with non-HCC malignancies within the past 5 years, excluding successfully treated squamous cell carcinoma and basal cell carcinoma of the skin * Patients with HCC involvement of a major branch(portal vein, hepatic vein, etc.) of any hepatic blood vessel on pathological evaluation c.f. Major branch is defined as the first or the second order branch (e.g. In case of the portal vein, right and left portal vein, right anterior and posterior portal vein, and left medial and lateral portal vein) * Patients with any evidence of extrahepatic HCC metastasis * Patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule * Use of any investigational drug or treatment up to 4 weeks before enrolling in the study and during the 24-month treatment period. * Hepatic artery stenosis or occlusion diagnosed by Doppler * Patients with severe renal insufficiency at randomization time point (GFR < 40mL/min, Proteinuria > 800mg/24hrs) * Patients with severe leucopenia and/or thrombocytopenia refractory to medical treatment (ANC < 500/ul,platelet < 30K/ul)

Study Objectives The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard chemotherapy and biological agents. Conditions: Colorectal Neoplasms Intervention / Treatment: DRUG: Nintedanib (BIBF 1120), DRUG: Placebo, DRUG: BSC, DRUG: BSC Location: Japan, Turkey, Israel, France, Taiwan, United Kingdom, Italy, Germany, Poland, Belgium, Austria, Sweden, Czechia, Australia, United States, Mexico, Canada, Spain, Portugal, Argentina, Denmark, Hong Kong, Russian Federation, Netherlands, Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion criteria: * Age >= 18 years * Signed informed consent * Histologically or cytologically confirmed colorectal adenocarcinoma * Metastatic or locally advanced disease not amenable to curative surgery and/or radiotherapy * Eastern Cooperative Oncology Group (ECOG) performance status = 1 * At least one measurable lesion according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 * Progression on standard therapies or withdrawn from standard treatment due to unacceptable toxicity. Previous standard treatment must include all of the following: * - fluoropyrimidine * - oxaliplatin: Patients treated with oxaliplatin in adjuvant setting should have progressed within 6 months of completion of adjuvant therapy or they must have been treated with oxaliplatin for metastatic disease * - irinotecan * - bevacizumab or aflibercept * - cetuximab or panitumumab for patients with K-Ras wt or Ras wt tumours * - The remaining standard available therapy as recommended by investigator is best supportive care (note: previous treatment with regorafenib and TAS 102 are allowed and these agents should be administered before study if available to patient according to local standards) * - Life expectancy of at least 12 weeks * - Hepatic function: aspartate aminotransferase (AST)/ Alanine Amino Transferase (ALT) = 1.5 X Upper Limit of Normal (ULN) and bilirubin = ULN for patients without liver metastases. AST/ALT = 2.5 X ULN and bilirubin = ULN for patients with liver metastases. Patients with Gilbert syndrome and bilirubin < 2 X ULN and normal AST/ALT are eligible * Coagulation parameters: International normalised ratio (INR) < 2 and partial prothrombin Time (PTT) = 2xULN Exclusion criteria: * Previous treatment with nintedanib * toxicity attributed to previous anticancer therapy that did not resolve to Common Terminology Criteria for Adverse Events (CTCAE) grade =1 * History of other malignancies in the last 5 years, in particular those that could interfere with interpretation of results. * Serious concomitant disease or medical condition affecting compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug, * Significant cardiovascular diseases * History of severe haemorrhagic or thromboembolic event in the past 12 months * Bleeding or thrombotic disorders requiring anticoagulant therapy such as warfarin, or similar agents requiring therapeutic INR monitoring * Gastrointestinal disorders or abnormalities that would interfere with absorption of study drug * Patient with brain metastases that are symptomatic and/or require therapy. * Patients of childbearing potential who are sexually active and unwilling to use a highly effective method of contraception * Pregnancy or breast-feeding.

Study Objectives This clinical trial studies idarubicin, cytarabine, and pravastatin sodium in treating patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndromes. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin sodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving idarubicin and cytarabine together with pravastatin sodium may kill more cancer cells. Conditions: Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Refractory Anemia With Excess Blasts, Untreated Adult Acute Myeloid Leukemia Intervention / Treatment: DRUG: pravastatin sodium, DRUG: idarubicin, DRUG: cytarabine, OTHER: laboratory biomarker analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of acute myeloid leukemia by World Health Organization (WHO) 2008 criteria, including patients with >= 20% blasts in the bone marrow or peripheral blood (except acute promyelocytic leukemia), or myelodysplastic syndrome refractory anemia with excess blasts (RAEB)-2 by WHO classification or advanced myeloproliferative neoplasm with >= 10% blasts in the bone marrow or peripheral blood, including chronic myelomonocytic leukemia (CMML) CMML-2 by WHO 2008 classification * Untreated AML or high-risk myelodysplastic syndrome (MDS) and a simplified TRM score of =< 9.2 * Bilirubin < 2.0 mg/ml * Any creatinine value is acceptable * Any performance status is eligible * Life expectancy otherwise > 1 year * Patients are not excluded based on cardiac history * Females of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment * Patients must use an effective contraceptive method during the study and for a minimum of 90 days after study treatment * Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent

Study Objectives Malignant pheochromocytoma/paraganglioma (MPP) and adrenocortical carcinoma (ACC) are two rare cancer entities with a very unfavorable prognosis. The knowledge on these rare cancers improved thanks to the French COMETE network originally based on two clinical centers (HEGP and Cochin) well organized for clinical and biological samples collection. Over the last 10 years, the COMETE key partners deciphered molecular mechanisms of tumorigenesis and oncogenesis of these tumors and identified molecular signatures discriminating between benign and malignant cancers by integrated genomic approaches. This strategy was highly successful in delivering new diagnostic applications of genomics technologies that now appear as potentially suitable for rapid implementation in routine clinical care. The main objective of COMETE-TACTIC is to provide an easy-to-use "identity card" of the adrenal tumors that will allow a personalized "à la carte" management of the patient and, when indicated, to the indication of the most accurate molecular targeted therapy. We hypothesize that the improvement of MPP and ACC diagnosis and of the therapeutic options proposed to affected patients will require, 1. the transfer to routine practice and the prospective validation of the novel diagnostic and predictive biomarkers issued from recent discoveries (genetics, genomics, histological biomarkers); 2. the implementation of the translational research projects based on the COMETE collection to identify circulating diagnostic, prognostic and therapeutic genetic and metabolic biomarkers that could be used as non-invasive "liquid biopsies". Conditions: Adrenal Gland Neoplasms Intervention / Treatment: BIOLOGICAL: omics identity card Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patient operated on a tumor developed from the adrenal cortex or a pheochromocytoma or a paraganglioma * Age≥15 years * Signature of the informed consent Exclusion Criteria: * None

Study Objectives The objective of this study is to collect disease status and overall survival information for all Subjects in MDX-010 studies. Conditions: Metastatic Melanoma Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Subjects who were previously enrolled in MDX-010 studies MDX010-02, MDX010-08, or MDX010-15. * Subjects (or if applicable, next of kin), who are alive at the time of contact must have read, understood, and provided written informed consent and health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained. * For subjects who have died or have been lost to follow-up(the subject status at end of original ipilimumab study), approval from the appropriate site IRB, specifying or limiting appropriate means for obtaining information, must be granted prior to collection of any information.

Study Objectives Review bladder cancer patients and form a database in regards to urine cytology. Conditions: Bladder Cancer Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Bladder cancer patients from Dr. Jay Hollander's private practice. Exclusion Criteria: * Patients with diagnosis of bladder cancer without initial cytology available. * Patients who received outside nephrectomy or cystectomy without pathology available. * Those who had recurrence without cytology results available. * Those who were followed by Dr Hollander and another urologist in which records are missing for a significant number of follow ups.

Study Objectives The objective of the study is to evaluate the impact and the outcome of bladder training during post-operative hospital stay after radical hysterectomy, mainly after neoadjuvant concurrent chemo-radiation therapy for locally advanced cervical cancer. Conditions: Uterine Cervical Neoplasms Intervention / Treatment: DEVICE: bladder training, PROCEDURE: No bladder training Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Women who underwent Querleu-Morrow class B2 and class C1 RH were enrolled in this randomized prospective study. Exclusion Criteria: *All the patients with preoperative urinary dysfunctions were excluded by study. Other exclusion criteria were surgery of lower urinary tract and psychiatric disease.

Study Objectives Primary Objective: -To examine the association between self-rated spirituality/religiosity and coping strategies (Brief RCOPE, Brief COPE, SBI-15R) among palliative care patients. Secondary Objectives: * To examine the associations between self-rated spirituality/religiosity and physical (ESAS) and psychological symptom reports (HADS), and quality of life (FACIT-sp) among palliative care patients. * To examine the association between patient's self-reported spirituality/religiosity, and primary caregiver distress (HADS, PSQI, CQLS-C, caregiver self-assessment questionnaire, FACIT-sp). * To determine the frequency (self-rated spiritual pain scale when score is more or equal than 1 in the scale 0 to 10) and intensity of self-rated spiritual pain in the palliative care setting and to explore the association between spiritual pain, and negative religious coping (Brief RCOPE), physical (ESAS) and psychological symptoms (HADS), and primary caregiver distress (CQLS-C, caregiver self-assessment questionnaire). * To examine the association between primary caregivers' spirituality/religiosity (Appendix H, first question), religious coping strategies (Brief-RCOPE) and psychological and family/caregiver distress (HADS, PSQI, CQLS-C, caregiver self-assessment questionnaire), and caregivers' spiritual pain (Appendix F, second question). Conditions: Advanced Cancer, Solid Tumors Intervention / Treatment: BEHAVIORAL: Questionnaires Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * (Patients) Advanced cancer patients seen in palliative care outpatient clinic and palliative care mobile team and inpatient unit at M.D. Anderson Cancer Center * (Patients) Patients aged 18 years or over * (Patients) Karnofsky performance status score of more than 40 at time of inclusion into study. (Patients with Karnofsky score less than 40 may not be able to complete the measures). * (Patients) Able to provide informed consent and comply with study procedures * (Caregivers) Spouse, first degree relative, or other person designated by the patient as providing direct assistance to the patient in his/her activities of daily living * (Caregivers) Having the patient's consent to be contacted. * (Caregivers) Caregiver is 18 years or over * (Caregivers) Able to provide informed consent and comply with study procedures * (Patients) only English-speaking, as determined by their ability to understand the informed consent and the assessment tools. * (Caregivers) only English-speaking, as determined by their ability to understand the informed consent and the assessment tools. * (Patients) Normal cognitive status as determined by the interviewer based on the ability to understand the nature of the study and consent process. Exclusion Criteria: N/A

Study Objectives The effect of overweight and obesity on IVF outcomes is still questionable. The purpose of this study was to determine if overweight/obesity in women with PCOS were associated with an adverse IVF outcome compared to those with normal weight. Design: Retrospective cohort study. Conditions: Polycystic Ovary Syndrome IVF Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * All women within the age limit

Study Objectives This study will find out if a meal replacement of this type is satisfying and tolerable for men with prostate cancer. Participants will receive meal replacements of TalityTM as their expected sole source of nutrition for 4 weeks. The purpose of the study is to test whether TalityTM Synthetic Meal Replacements are suitable to be used in larger studies of patients with prostate or other types of cancer. Conditions: Prostate Cancer Intervention / Treatment: OTHER: Tality Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Biopsy-proven prostate cancer with stable or rising PSA levels, defined as three consecutive PSA levels, each value greater than 1 week apart, with fluctuation between the three values no more than 10% downward. The third PSA needs to be within 30 days prior to enrollment and >= 0.1. * Patients may previously have been on any regimen of chemotherapy completed at least one month prior. Patients may be on any stable form of anti-androgen therapy. * Males >= age 18. * All patients must have a life expectancy of > 6 months. * Patients must have an ECOG Performance Status of <= 1 * Patients must have no clinically significant abnormalities of organ or bone marrow function * Patients must have the ability to understand and the willingness to sign a written informed consent document, and the willingness/ability to comply with the protocol activities. Exclusion Criteria: * Chemotherapy within one month prior to enrollment or plans to receive chemotherapy within one month after enrollment. Patients who are expected to require new or modified anti-androgen therapy during the course of the study are also excluded. * Patients may not be receiving any other Investigational Agents during the course of the study. * Patients who experience frequent symptoms of a gastrointestinal nature (e.g., diarrhea, abdominal bloating, constipation or pain) are excluded. * Known CNS metastases. * Patients who, in the opinion of the Principal Investigator, have a clinically significant co-morbid disease that is likely to affect the ability of the patient to complete the trial, interfere with their ability with measurement of self-reported outcomes or result in adverse events unrelated to TalityTM are excluded. * Patients with a history of food allergy are excluded. * Concomitant medications necessary to treat baseline disorders are allowed (e.g., hypertension, diabetes, and hyperlipidemia). * Patients requiring concomitant medications that, in the opinion of the Principal Investigator, have an unacceptable risk of adverse effects due to their nature (e.g., anti-coagulant therapy, immuno-modulatory agents for autoimmune disease) must be excluded. * Pregnant or nursing patients will not be enrolled since prostate cancer is limited to males. * HIV-positive patients with active infections, HIV related cancer or poorly controlled viral loads must be excluded. HIV-positive patients who are stable on anti-viral therapy may be enrolled.

Study Objectives The purpose of this research study is to determine the safety of CCI-779 (Temsirolimus) and bortezomib (Velcade), and the highest dose of this drug that can be given to people safely. We will also be looking at how the combination of the two drugs may work against multiple myeloma. CCI-779 (Temsirolimus) is a drug that appears to stop myeloma cells from growing. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: CCI-779, DRUG: Bortezomib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * 18 years of age or older * Must have received prior therapy for their myeloma and have relapsed and/or relapsed/refractory multiple myeloma * Monoclonal protein in the serum of greater than or equal to 1 gm/dL or monoclonal light chain in the urine protein electrophoresis of greater than or equal to 200mg/24 hours, or measurable light chains by free light chain assay of greater than or equal to 10mg/dl, or measurable plasmacytoma * ECOG Performance Status 0, 1 or 2 * Laboratory values as outlined in the protocol Exclusion Criteria: * Uncontrolled infection * Cytotoxic chemotherapy less than 2 weeks, or biologic therapy less than 2 weeks, or corticosteroids less than 2 weeks prior to registration. Patients may be receiving chronic corticosteroids if they are being given for disorders other than myeloma. * Pregnant or nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception * Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational within 14 days before enrollment * Known to be HIV positive * Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV hear failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities * Hypersensitivity to bortezomib, boron or mannitol * Serious medical or psychiatric illness likely to interfere with participation in this clinical trial * Patients who may need or are receiving live vaccines for immunization

Study Objectives Medical progress have made it possible to considerably improve the survival of children with an oncological disease. Currently, the survival rate increased to above 90 % in the most developed countries . This increase of childhood cancer survivors (CCS) asks us about their future and their quality of life. Assessing health related life quality , previous studies observe that in this particular population of patients, it is related to a poor physical capacity , physical activity level and many of these patients do not meet the activity level recommended by the world health organization due to fatigability and sedentary behaviours . In addition to these habits, the CCS are more susceptible to develop cardiovascular risk (CVR) leading to cardiovascular disease in adulthood and increases them mortality . Furthermore, CCS who have been experiencing hematopoietic stem cells transplantation (HSCT) are more susceptible to develop these CVR. In parallel with the common CVR, lower cardiopulmonary fitness assessed by cardiopulmonary exercise test (CPET) in the general population has been established as a major and independent CVR for cardiologic events. Cardiopulmonary fitness assessed by maximal cardiopulmonary exercise test (CPET) allows physicians to measure metabolic response to maximal effort in a population that is known as VO2max. This domain of applied physiology permits a new way to approach the understanding of global health prognosis in chronic disease. For example, decrease of VO2max is involved in lower quality of life in patients with congenital heart disease. Cardiopulmonary exercise test for VO2max exploration has been demonstrated feasible in child patients with leukemia or other tumors after intensive chemotherapy, prior to HSCT. Assessment of cardiopulmonary fitness in CCS is already described in previous studies, but this study aimed to compare a maximal CPET assessment on a large childhood cancer survivors cohort with healthy control, on a quite young cohort, during the oncologic follow up and find out its determinants. Conditions: Childhood Cancer Location: France Study Design and Phases Study Type: OBSERVATIONAL

Inclusion criteria for CCS group : * aged between 5 and 25 years old, * having been complete a full regimen for oncological disease and considered in remission at the end of treatment. Remission was considered in absence of relapse or new treatment initiated before the CPET end point. Inclusion criteria for control group : * children referred for a nonsevere functional symptom linked to exercise (murmur, palpitation or dyspnoea) or for a medical sports certificate. * completely normal check-up, including physical examination, ECG, echocardiography and spirometry. Exclusion criteria for control group: * Children with any chronic disease, medical condition (cardiac, neurological, respiratory, muscular or renal) * Children with any medical treatment * Children requiring any further specialised medical consultation

Study Objectives RATIONALE: Antiviral drugs, such as ganciclovir, act against viruses. Giving ganciclovir by infusion and then by mouth may be effective treatment for cytomegalovirus that has become active after donor bone marrow transplant. PURPOSE: This phase II trial is studying how well giving ganciclovir by infusion and by mouth works in treating patients with cytomegalovirus after donor bone marrow transplant. Conditions: Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Leukemia, Lymphoma, Multiple Myeloma, MDS, Myelodysplastic/Myeloproliferative Diseases Intervention / Treatment: DRUG: Ganciclovir Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: SUPPORTIVE_CARE Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: DISEASE CHARACTERISTICS: * Undergoing allogeneic transplantation, including unrelated donor bone marrow transplantation (BMT) and/or allogeneic donor leukocyte infusion, for any indication * Patients or their donors must have had a positive pre-BMT cytomegalovirus (CMV) antibody titer as measured by enzyme-linked immunosorbent assay (ELISA) PATIENT CHARACTERISTICS: * Able to comply with study requirements Exclusion criteria: * Signs or symptoms of documented CMV infection, including any positive CMV culture from any site and/or any suspected or documented CMV-associated clinical syndrome, at the time of study entry * History of symptomatic CMV-associated clinical syndrome PRIOR CONCURRENT THERAPY: * Receiving concurrent investigational antiviral agents PATIENT CHARACTERISTICS: * History of hypersensitivity to ganciclovir or acyclovir

Study Objectives The main objective of this study is to compare conventional chemotherapy: daunorubicin and the Aracytine and this chemotherapy in combination with the monoclonal antibody used Mylotarg in divided doses. Conditions: Acute Myeloid Leukemia Intervention / Treatment: DRUG: conventional chemotherapy (AraC + Daunorubicin),, DRUG: Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin), Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients with a morphologically proven diagnosis AML and both the two following criteria: Age > 50 years and £ 70 years. Not previously treated for their disease. * ECOG performance status 0 to 3 * Negative serology HIV, HBV and HBC (except post vaccination) * Serum creatinin inf 2.5N; AST and ALT inf 2.5N; total bilirubin inf 2N * Cardiac function determined by radionucleide or echography within normal limits. * Negative serum pregnancy test within one week before treatment for women of child bearing potential. * Signed informed consent. Exclusion Criteria: * M3-AML * AML following previously know myeloproliferative syndrome. * Known central nervous system involvement. * Uncontrolled infection * Other active malignancy

Study Objectives This study includes the additional use of radiation therapy in combination immunotherapy in order to determine whether the radiation may improve the response of non-small cell lung cancer to immunotherapy and to monitor any side effects. Conditions: Non Small Cell Lung Cancer Metastatic Intervention / Treatment: RADIATION: Radiation, DRUG: Immuno-Therapeutic Agent Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Stage IV metastatic Non Small Cell Lung Cancer * Measurable disease of at least 1.5 cm in greatest dimension at least 2 non-irradiated sites (except for lymph nodes, in which the short-axis dimension must be at least 1.5cm). There must be at least 1 visceral organ metastasis outside of the brain. * History of prior cytotoxic chemotherapy (with or without concomitant radiation therapy) with subsequent distant (metastatic) disease relapse, or progression of disease while on chemotherapy. * Participant must be planned to receive (or actively receiving) standard of care checkpoint inhibitor immune therapy. For those patients actively receiving checkpoint inhibitor immune therapy the duration of immune therapy at the time of enrollment must be 4 months or less. * Life expectancy greater than 3 months Exclusion Criteria: * Active autoimmune disease, primary immunodeficiency syndrome, HIV/AIDS, or hepatitis B or C * Oral corticosteroid dependency * Uncontrolled or untreated active brain metastases/CNS disease * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia

Study Objectives The aim of this clinical trial is to see if the drug called AZD2014 is effective and safe to use to treat patients with relapsed or refractory Diffuse Large BCell Lymphoma (DLBCL). The trial will also be looking at combining the antibody (Rituximab) with the drug AZD2014 in a small number of patients to see if this can be done without increasing the toxicity. 36 patients will be recruited to the trial. 30 will receive AZD2014 alone and the remaining 6 will receive AZD2014 plus rituximab. AZD2014 will be given as a 125mg tablet that is to be taken twice a day for 2 days out of every 7 (i.e. on days 1 and 2 of every week). Rituximab will be given via IV infusion on day 1 of every 28 days (once every 4 weeks) for a maximum of 6 cycles. Conditions: Diffuse Large B-Cell Lymphoma Intervention / Treatment: DRUG: AZD 2014, DRUG: Rituximab Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) relapsing after at least 1 course of potentially curative, anti-CD20 antibody containing regimen (e.g. RCHOP, GCHOP, RGCVP). High grade transformation from low grade lymphoma (e.g. follicular lymphoma, lymphoplasmacytic lymphoma, chronic lymphocytic leukaemia) is permitted. Patients must have relapsed post-ASCT or be considered not suitable for ASCT. * Tissue biopsy (or bone marrow trephine if no other tissue available) confirming histology within 3 months of enrolment. * Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses. * Aged at least 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. * Females should be using adequate contraceptive measures (as described in the protocol, different for patient receiving rituximab), should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: * Post-menopausal defined as amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments * Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation * Male patients should be willing to use barrier contraception (i.e. condoms) as described in the protocol, (different for patient receiving rituximab\*) * Ability to swallow and retain oral medication * CT measurable disease with at least 1 lesion having short axis ≥ 1.5cm or splenomegaly ≥ 14cm in cranio-caudal length attributable to relapsed lymphoma * Patients must have negative virology for HIV, hepatitis B and hepatitis C prior to trial entry. Patients with an isolated anti-hepatitis B sAg antibody may be entered as this indicates previous vaccination.. These patients MUST have HBV DNA tested. Exclusion Criteria: Patients must not enter the study if any of the following exclusion criteria are fulfilled: * Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents, and any investigational agents within 14 days of registration (not including palliative radiotherapy at focal sites). Corticosteroids are permitted during screening but should be weaned down to a maximum dose of prednisolone 10mg daily (or equivalent) by day 1 of cycle 1. - With the exception of alopecia, any unresolved toxicities from prior chemotherapy should be no greater than CTCAE (Version 4.0) Grade 2 at the time of registration. * Major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study. * Exposure to potent or moderate inhibitors or inducers of CYP3A4/5 if taken within the stated washout periods before the first dose of study treatment. * Exposure to potent or moderate inhibitors or inducers of CYP2C8 if taken within the stated washout periods before the first dose of study treatment. * Exposure to sensitive or narrow therapeutic range substrates of the drug metabolising enzymes CYP2C8, CYP2C9, CYP2C19, CYP2D6 or the drug transporters Pgp (MDR1), BCRP, OATP1B1, OATP1B3, OCT1 and OCT2 within the appropriate wash-out period (a minimum of 5 x the reported terminal elimination half-life of each drug) before the first dose of study treatment. * Previous treatment with any first generation mTORC1 inhibitors (rapamycin, sirolimus, temsirolimus, everolimus) or any dual mTORC1/2 inhibitors (e.g. AZD2014, AZD8055). * Patients who have experienced intolerable AEs prejudged by the treating Investigator due to other mTORC1 or mTORC1/2 inhibitors, PI3 kinase inhibitors, or AKT inhibitors. * Patients with proven central nervous system (CNS) involvement. * As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases (e.g., severe hepatic impairment, interstitial lung disease (e.g.bilateral, diffuse, parenchymal lung disease), uncontrolled chronic renal diseases (e.g. glomerulonephritis, nephritic syndrome, Fanconi Syndrome or Renal tubular acidosis) or current unstable or uncompensated respiratory or cardiac conditions, or uncontrolled hypertension, active bleeding diatheses or active infection. Screening for chronic conditions is not required. * Patients who have experienced any of the following procedures or conditions currently or in the preceding 12 months: * coronary artery bypass graft * angioplasty * vascular stent * myocardial infarction * angina pectoris * congestive heart failure New York Heart Association Grade ≥2 * ventricular arrhythmias requiring continuous therapy * supraventricular arrhythmias including atrial fibrillation, which are uncontrolled * haemorrhagic or thrombotic stroke, including transient ischaemic attacks or any other central nervous system bleeding * Abnormal echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) at baseline (left ventricular ejection fraction \[LVEF\] <50%). * Torsade's de Pointes within 12 months of study entry. * Mean (3 consequent ECGs 1 minute apart) resting QTcF and QTcB >470 msec as per local reading. * Concomitant medications known to prolong QT interval, or with factors that increase the risk of QTc prolongation or risk of arrhythmic events (such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age). * Patients with Diabetes Type I or uncontrolled Type II (HbA1c >7 mmol/L assessed locally) as judged by the local investigator. * Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values unless due to underlying NHL infiltration. * Absolute neutrophil count <1.5 x 10\^9/L (without GCSF / GMCSF support) * Platelet count <100 x 10\^9/L * Haemoglobin <90 g/L (transfusions permissible) * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 times the upper limit of normal (ULN) if no demonstrable liver involvement or >5 times ULN in the presence of liver involvement * Total bilirubin >1.5 times ULN unless in the presence of Gilbert's syndrome with an elevated indirect fraction * Serum creatinine >1.5 times ULN concurrent with creatinine clearance ≤50 mL/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is >1.5 times the ULN * Current refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD2014. * History of known hypersensitivity to active or inactive excipients of AZD2014 or drugs with a similar chemical structure or class to AZD2014. * Judgment by the Investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements. * Previous history of other active malignant disease other than fully excised basal or squamous cell carcinoma of the skin, carcinoma in situ of the uterine cervix or localised disease treated with curative intent using surgery alone, within the last 3 years. For the rituximab cohort only, patients must not enter the study if any of the above or below exclusion criteria are fulfilled: * Known hypersensitivity to recombinant proteins, murine proteins or to any excipients of rituximab infusions * Vaccination with live virus vaccine within the 4 weeks prior to study entry or intention to do so during the study treatment

Study Objectives A non-randomized phase II study to determine the efficacy and safety of the combination of Gemcitabine and Oxaliplatin followed by Gemcitabine and radiotherapy in patients with surgically resected pancreatic cancer. Conditions: Pancreatic Neoplasms Intervention / Treatment: DRUG: Gemcitabine, DRUG: Oxaliplatin, PROCEDURE: Radiotherapy Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Pathologically confirmed adenocarcinoma of the pancreas * Patient have undergone a potentially curative resection * No previous irradiation to the planned field * Negative pregnancy test for child bearing women Exclusion Criteria: * Non-adenocarcinoma pancreatic cancer * Treatment with any drug within the last 30 days that has not received regulatory approval. * Serious systemic disorder * Metastatic disease * Pregnancy, breast feeding

Study Objectives Phase II trial to study the effectiveness of bortezomib in treating patients who have low-grade lymphoproliferative disorders. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Conditions: Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma Intervention / Treatment: DRUG: bortezomib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed lymphoproliferative disorder of 1 of the following subtypes: * \* Relapsed or refractory grade I, II, or III follicular center cell lymphoma * Relapsed or refractory mantle cell lymphoma * Measurable disease for non-Hodgkin's lymphoma (NHL) only * At least 1 unidimensionally measurable lesion * At least 2 cm by conventional techniques OR at least 1 cm by spiral CT scan * Lymph nodes no greater than 1 cm in short axis considered normal * Absolute lymphocytosis greater than 5,000/mm\^3 with B-cell phenotype (CD19, 20,or 23 positive) with more than 30% bone marrow lymphocytes for CLL or other leukemic forms of NHL * No known brain metastases * Performance status - Karnofsky 70-100% * At least 3 months * See Disease Characteristics * Absolute neutrophil count greater than 1,500/mm\^3 (500/mm\^3 if lymphomatous involvement of bone marrow) * Platelet count greater than 50,000/mm\^3 * Bilirubin less than 1.5 times upper limit of normal (ULN) * AST and ALT no greater than 2.5 times ULN (4 times ULN in case of liver metastases) * Creatinine less than 1.5 times ULN * No symptomatic congestive heart failure * No New York Heart Association class III or IV heart disease * No unstable angina pectoris * No cardiac arrhythmia * No myocardial infarction within the past 6 months * No cerebrovascular accident or transient ischemic attack within the past 6 months * No history of orthostatic hypotension * No evidence of acute ischemia or significant conduction abnormality (left anterior hemiblock in the presence of right bundle branch block or second or third degree atrioventricular blocks) on electrocardiogram * No uncontrolled hypertension requiring antihypertensive medication * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Febrile episodes up to 38.5°C allowed if no evidence of active infection * No other uncontrolled concurrent illness * No known or active HIV infection * No ongoing or active infection * No psychiatric illness or social situation that would preclude study entry * At least 3 months since prior monoclonal antibody therapy (e.g., rituximab) * No more than 3 prior regimens of conventional cytotoxic chemotherapy * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * At least 1 week since prior steroid therapy * At least 4 weeks since prior radiotherapy and recovered * At least 4 weeks since prior major surgery * No other concurrent investigational agents

Study Objectives The Study Buddy ECA acts as an advisor to patients on chemotherapy regimens, promoting protocol adherence and retention, providing anticipatory guidance and answering questions, serving as a conduit to capture information about complaints or adverse events, providing a venue for communicating about updates. The Study Buddy will use the web-based ECA infrastructure developed for use on another project. We will use web browsers on tablets provided to study participants to access the Study Buddy, providing anywhere, anytime access to its functions. Usability metrics will include session time, satisfaction, and error rates. Conditions: Patient Satisfaction, Patient Compliance, Guideline Adherence Intervention / Treatment: BEHAVIORAL: Chemo Buddy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * speaks English fluently * is able to independently consent into this study and parent cancer study * has adequate corrected vision to use the ECA system (based on a 1-minute functional screener) * has adequate hearing to use the ECA system Exclusion Criteria: * suicidal or homicidal * currently in police custody * do not live in the Boston area * plan on leaving the Boston area for more than 4 weeks in the next 6 months * score 6 or less on the SPMSQ screening test

Study Objectives The main aim of this study is to determine whether there is a difference in time to diagnosis of advanced colorectal neoplasms using quantitative Fecal Immunochemical Tests (FIT) to prioritize referral for colonoscopy (intervention) compared to usual care (qualitative FIT and appointment-based referral). Conditions: Colorectal Cancer Intervention / Treatment: OTHER: Qualitative fecal immunochemical test, OTHER: Quantitative fecal immunochemical test, PROCEDURE: Colonoscopy, OTHER: Cost analysis, OTHER: Anxiety scores, OTHER: Patient satisfaction scores Location: Malaysia Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SCREENING Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Adults aged 50 years and above Exclusion Criteria: * Lower gastrointestinal tract symptoms such as diarrhoea, constipation, per rectal bleeding * Personal history of colorectal tumour or cancer * Family history of familial adenomatous polyposis or hereditary non-polyposis colorectal cancer

Study Objectives This study is intended to test an experimental drug called EMD 525797 (Abituzumab). This drug is not yet approved for sale and has only been tested in a small number of people to date (prior to this study starting another research study was carried out involving 37 healthy volunteers receiving the study drug). Until more is known about this study drug, it can only be used in research studies. This research study is planned to answer important questions about how the study drug is tolerated and how it may work in subjects with ovarian and colorectal cancer which has spread to the liver (i.e. metastatic cancer). The Sponsor (Merck KGaA) of this study is developing the study drug. Conditions: Colorectal and Ovarian Cancer Patients With Liver Metastases Intervention / Treatment: BIOLOGICAL: EMD 525797 Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Provision of signed written informed consent * Male or female subjects, aged at least 18 years * Subjects with liver metastases (3 to 10 centimeter \[cm\] diameter) from colorectal and ovarian cancers * Failure of standard cancer therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at study entry and an estimated life expectancy of at least 3 months * Adequate haematological function, defined by absolute neutrophil count (ANC) greater than or equal to (>=) 1.5 x 10\^9 per liter (/L), platelet count >= 100 x 10\^9 / L, and haemoglobin concentration >= 9 gram per deciliter (g/dL) * As subjects with documented liver metastases are treated in this trial, liver function test values are accepted as followed: up to the upper limit of Grade 2 as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. This includes total bilirubin level less than or equal to (=<) 3 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels =<5 x ULN * Adequate renal function defined by serum creatinine =<1.5 x ULN or a creatinine clearance of >=50 milliliter per minute (mL/min) calculated by Cockcroft-Gault * Effective contraception (example: double barrier method) for both male and female subjects if the risk of conception exists. These subjects must be willing to avoid pregnancy during the study (screening to end of study \[EOS\]) as well as for at least 3 months after the last dosing. Exclusion Criteria: * Any systemic cancer treatment within 30 days before treatment with EMD 525797 * Thrombolytics or oral or parenteral anticoagulants (except to maintain patency of preexisting, permanent indwelling intravenous catheters) within 10 days prior to study start and during treatment * Radiotherapy, chemotherapy, surgery, or any investigational drug in the 30 days before the start of treatment in this study, and/or diagnostic biopsies within 2 weeks before the start of treatment in this study * Previous treatment with anti-integrin therapy or anti angiogenic therapy within the last 6 months * Confirmed or clinically suspected brain metastases * Known hypersensitivity reactions to the study medication * History of allergic reactions to other monoclonal antibody (mAb) therapy * Uncontrolled hypertension (systolic blood pressure greater than (>) 180 millimeter of mercury (mmHg), diastolic >100 mmHg) * Current history of chronic daily aspirin therapy (doses of =< 150 mg is permitted), bleeding disorders, and/or history of thromboembolic events * Severe peripheral vascular disease or ulceration * Unstable angina pectoris, or myocardial infarction within 6 months before start of study treatment, clinical significant abnormal electrocardiogram (ECG) at screening; * In women of childbearing potential, pregnancy (absence to be confirmed by beta human chorionic gonadotropin \[β HCG\] test, unless a subject has previously undergone hysterectomy or bilateral ovariectomy), or lactation period * Known alcohol or drug abuse * Participation in another clinical trial within the past 30 days before start of study treatment * All other significant diseases which, in the opinion of the principal investigator (PI), might impair the subject's tolerance of study treatment * Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent * Legal incapacity or limited legal capacity (not applicable only in rare cases) * Known human immuno deficiency (HIV) infection and/or active hepatitis B or C virus infections * Ongoing uncontrolled infections * Contraindications to magnetic resonance imaging (MRI)

Study Objectives Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients. The ONCO-CODES (Computerized DEcision Support in ONCOlogy) trial is a pragmatic, parallel group, randomized controlled study with 1:1 allocation ratio Study Duration 12 month Study Center(s) Single-center Objectives: The primary outcome of this trial is a process outcome. i.e. the rate at which the issues reported by the reminders are resolved (resolution rates). Conditions: Medical Oncology Intervention / Treatment: OTHER: computer reminders on clinical practice, OTHER: Control group Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: HEALTH_SERVICES_RESEARCH Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * The Investigators will include all the EHRs of patients admitted to the facilities of the IRST IRCCS. Exclusion Criteria: * There are no exclusion criteria.

Study Objectives The purpose of this study is to evaluate efficacy, safety, and patient reported outcomes (PRO) of different regimens of transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC). Conditions: Hepatocellular Carcinoma Intervention / Treatment: PROCEDURE: Transarterial chemoembolization (TACE), PROCEDURE: Transarterial chemoembolization (TACE), PROCEDURE: Transarterial chemoembolization (TACE) Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: FACTORIAL Masking: SINGLE

Inclusion Criteria: * Adult patients with minimal height of 150cm and minimal weight of 50 KG * Histological confirmed HCC * with no previous treatment * With unresectable tumor * With solitary or multiple intrahepatic tumor, the diameter of the largest one must larger than 7cm. * No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A only * No significant renal impairment (creatinine clearance < 30 mL/minute) * The following laboratory parameters: * Platelet count ≥ 60,000/µL * Hemoglobin ≥ 8.5 g/dL * Total bilirubin ≤ 1.5 mg/dL * ASL and AST ≤ 5 x upper limit of normal * Serum albumin ≥ 35 g/L * Serum creatinine ≤ 1.5 x upper limit of normal * INR ≤ 1.5 or a Pt/PTT within normal limits * Absolute neutrophil count (ANC) > 1,500/mm3 * Ability to understand the protocol and to agree to and sign a written informed consent document Exclusion Criteria: * Avascular tumor * Main portal vein obstruction without cavernous transformation * Evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy * Obstructive jaundice * Severe underlying cardiac or renal diseases * Known or suspected allergy to the investigational agent or any agent given in association with this trial * Pregnant or breast-feeding patients. * History of organ allograft * Active clinically serious infections * Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study

Study Objectives Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The phase I study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemo-radiotherapy in patients with locally advanced esophageal cancer tumours. Conditions: Advanced Esophageal Intervention / Treatment: DRUG: Nimotuzumab Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Informed consent form signed before performing any of the study's specific procedures. * ECOG performance status 0-2. * Age > 18 and < 75. * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, greater than or equal to 1 cm (longest diameter) by spiral computed tomography (CT) scan and MRI or greater than or equal to 2 cm by other ordinary radiographic technique. * Histologically confirmed diagnosis of locally advanced esophageal. * Life expectancy of more than 3 months. * Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy. * No serious blood producing,abnormal function of heart,lung, liver, or kidney or immuno-deficiency * Neutrophils ≥3×109/L, platelet count≥100×109/L and haemoglobin≥9g/dL ,Creatinine ≤ 1.5 x NUL Exclusion Criteria: * Previous radiotherapy or chemotherapy * Pregnant or breast-feeding women * Drug abuse, unhealthy drug/alcohol addiction,or virus (HIV) infection * Evidence of distant metastasis * Participation in other clinical trials * Patients with aphthosis, complete obstruction, fistula or deep peptic ulcer in the esophagus, or haematemesis * Uncontrolled psychiatric disease or seizure * Patients not fit for the clinical trial judged by the investigators

Study Objectives To decide maximum tolerated dose and/or recommended dose of Gemcitabine or S-1 adjuvant therapy after hemihepatectomy Conditions: Biliary Tract Cancer Intervention / Treatment: DRUG: Gemcitabine, DRUG: S-1 Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Biliary tract cancer (>= UICC Stage IB) * R0 or R1 resection due to biliary tract cancer (BTC) * ECOG performance status must be 0 or 1 * The patient underwent no other treatment than surgery for BTC * Neutrophil must be over 1500/μl, platelet must be over 100,000/μl, AST and ALT must be less than five times the normal limit, total bilirubin must be less than three times the normal limit, and creatinin must be less than 1.2 mg/dl. * The patient can intake drugs per os. * From 4 to 12 weeks after the surgery * Written informed consent Exclusion Criteria: * Existence of active double cancer * The patient suffered from severe drug allergy * Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on) * Any active infections exist. * Pregnancy * Severe mental disorder * Others

Study Objectives The purpose of the study is the identification of chromosomal aberrations in urine samples. The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classification of UroVysion FISH stained Urine samples. Conditions: Bladder Cancers Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Well stained slides with bright FISH signals Exclusion Criteria: * Very old slides that were already bleached

Study Objectives The overall study objective is to evaluate the effectiveness and safety of Trastuzumab emtansine (T-DM1) and Pertuzumab under real-world disease conditions in the Spain, and specifically in patients treated under compassionate use or early access program Conditions: Breast Neoplasms Location: Spain Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Adult patients (age ≥ 18 years at enrolment) with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) or Pertuzumab. * Patients who initiate Trastuzumab emtansine (T-DM1) and Pertuzumab under Spanish compassionate use or early access program. Exclusion Criteria: * Given the characteristics of the study there are no exclusion criteria.

Study Objectives Cancer related fatigue (CRF) has been defined as a "distressing, persistent, subjective sense of tiredness or exhaustion related to cancer or cancer treatment that is not proportional to recent activity and interferes with usual functioning". CRF has been found to affect between 59-99% of patients undergoing active treatment. Approximately a third of cancer survivors will continue to experience moderate to severe fatigue upwards of 10 years post-diagnosis. Given the prominence of CRF, guidelines for the assessment and management of CRF have been developed, including guidelines by the Canadian Association for Psychosocial Oncology (CAPO). Despite the availability of guidelines for CRF and a plethora of interventions that have demonstrated effectiveness in aiding patients manage CRF, implementation has been lacking. The objective of this study is to adapt, implement, and evaluate an already existing intervention for CRF in the community using the Knowledge-to-Action framework. This study is an implementation study and evaluation of an evidence-based cognitive-behavioral therapy intervention for CRF in a community setting. An evident knowledge to practice gap exists for CRF management in Ottawa, Canada. Through partnership with a community organization, the Ottawa Regional Cancer Foundation, and an emphasis on long-term sustainability, this project aims to provide more accessible treatment for cancer survivors who are experiencing CRF in the Ottawa region. Conditions: Cancer, Fatigue, CBT Intervention / Treatment: BEHAVIORAL: Cognitive Behavioral Therapy to manage cancer-related fatigue Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Aged 18 and over * Has received a cancer diagnosis * Has completed cancer treatment, * Self-reports experiencing fatigue, * Fluent in English. Exclusion Criteria: * Currently in treatment * Has a diagnosis of brain cancer and is experiencing cognitive difficulties

Study Objectives The purpose of this study is to learn whether 3 tesla (3T) MRI functional imaging will map a tumor more accurately allowing a more targeted delivery of radiation. The investigators hope to learn whether tomotherapy will be able to deliver higher radiation doses safely to the tumor while sparing the surrounding normal tissue. Conditions: Glioblastoma, Glioma Intervention / Treatment: PROCEDURE: Functional MRI imaging and tomotherapy Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed glioblastoma multiforme * Ages 18-65 * Karnofsky Performance Scale (KPS) equal to or less than 70 * Minimal neurological deficit * Eligible for concurrent temozolomide chemotherapy Exclusion Criteria: * Prior radiation therapy to hand or neck area, chemotherapy, or radiosensitizer

Study Objectives Improvements in cancer treatment have led to an increasing number of patients being cured or in remission, but they are followed up to detect recurrence, manage persistent symptoms and late treatment effects. With growing survivors, traditional hospital follow-up is not sustainable. New models of follow-up care are needed. This research project aims to develop and establish the feasibility of introducing a new electronic care pathway/system for remote monitoring ovarian cancer patients in remission. The project includes a development phase, followed by an audit \& pilot intervention phase to explore the feasibility of a new pathway/system for remote monitoring. Conditions: Cancer Intervention / Treatment: DEVICE: ePRIME Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: HEALTH_SERVICES_RESEARCH Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Adult patients (aged 18 years or over) attending St James' University Hospital Bexley Wing, Bradford Teaching Hospitals NHS Foundation Trust, Calderdale \& Huddersfield NHS Foundation Trust, and Airedale NHS Foundation Trust with stage 2-4 ovarian/fallopian/peritoneal/endometrial cancer in remission following the end of first or second line chemotherapy or end of maintenance Avastin/Bevacizumab (where indicated) * Patients may have recently completed treatment or already been on routine clinic-based face-to-face follow-up at the time of recruitment into the pilot intervention phase * Able and willing to give informed consent * Able to read and understand English * Access to the internet Exclusion Criteria: * Exhibiting overt psychopathology/cognitive dysfunction * Taking part in other clinical trials involving the completion of extensive patient reported outcome or quality of life measures or requiring scheduled face-to-face clinical outpatient appointments (Intervention group only)

Study Objectives To evaluate the safety and primary immunogenicity of the quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (hansenula polymorpha) in Chinese female subjects aged 9-45 years. Conditions: HPV Infections Intervention / Treatment: BIOLOGICAL: HPV vaccine, BIOLOGICAL: Placebo Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Healthy females between, and including, 9 and 45 years of age at the time of enrolment * Be able to provide legal identification for the sake of recruitment * Be able to understand and sign informed consent form prior to enrollment and for subjects aged 9-17 years, they and their legal guardian(s) are supposed to understand and sign informed consent form together * Subjects who the investigator believes that they can and will comply with the protocol requirements * Subject must be not pregnant at the enrollment and agree to use adequate contraceptive precautions within 7 months or don't have pregnancy plan Exclusion Criteria: * Fever or axillary temperature> 37.0℃ before vaccination * Previous vaccination against HPV, or planned administration/administration of a vaccine not foreseen by the study protocol within 30 days preceding first dose of vaccine; Planned to take part in other clinical research within 7 months after participating this study * Abnormal laboratory tests parameters * Administration of any whole blood, plasma or immunoglobulins products within 3 months preceding first vaccination * Interval between administration of the study vaccination and any attenuated live vaccine less than 14 days, and other vaccines less than 10 days * History of serious allergic disease requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock) * History of to adverse event to vaccine, or allergic to some food or drug * History of epilepsy, seizures or convulsions, or family history of mental illness * Subjects are immunocompromised or have been diagnosed as suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis inflammation (JRA), inflammatory bowel disease or other autoimmune diseases, administration of immunosuppressants with six months prior to the first vaccine dose. * Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy * Subject to severe hepatorenal disease, cardiovascular disease, hypertension, diabetes, malignant tumor, all kinds of infectious diseases and acute illness, or during chronic disease acute attack period * Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder * During menstrual period or acute disease period of onset * Breastfeeding, pregnancy (including pregnancy test positive), or planned to be pregnant within 7 months * Abnormal cervical cancer screening or subject to CIN or acuteness wet wart that relevant to HPV infection in the past two years * Planned to moveout of local before the end of the study or leave the local for a long time during the study period * Other unsuitable factors for the study judged by investigators

Study Objectives Treatment standard for patients with rectal cancer depends on the initial staging and includes surgical resection, radiotherapy as well as chemotherapy. For stage II and III tumors, radiochemotherapy should be performed in addition to surgery, preferentially as preoperative radiochemotherapy or as short-course hypofractionated radiation. Advances in surgical approaches, especially the establishment of the total mesorectal excision (TME) in combination with sophisticated radiation and chemotherapy have reduced local recurrence rates to only few percent. However, due to the high incidence of rectal cancer, still a high absolute number of patients present with recurrent rectal carcinomas, and effective treatment is therefore needed. Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increase relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on the cell line as well as the endpoint analyzed. Japanese data on the treatment of patients with recurrent rectal cancer previously not treated with radiation therapy have shown local control rates of carbon ion treatment superior to those of surgery. Therefore, this treatment concept should also be evaluated for recurrences after radiotherapy, when dose application using conventional photons is limited. Moreover, these patients are likely to benefit from the enhanced biological efficacy of carbon ions. In the current Phase I/II-PANDORA-01-Study the recommended dose of carbon ion radiotherapy for recurrent rectal cancer will be determined in the Phase I part, and feasibility and progression-free survival will be assessed in the Phase II part of the study. Within the Phase I part, increasing doses from 12 x 3 Gy E to 18 x 3 Gy E will be applied. The primary endpoint in the Phase I part is toxicity, the primary endpoint in the Phase II part its progression-free survival. Conditions: Recurrent Rectal Cancer Intervention / Treatment: RADIATION: Carbon Ion Radiotherapy Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria * Locally recurrent rectal cancer * Inoperable lesion * Macroscopic tumor up to 1000ml volume- prior photon radiation of 20-60 Gy * time between initial radiotherapy and re-irradiation of at least 12 months * age ≥ 18 years of age * Karnofsky Performance Score >60 * For women with childbearing potential, (and men) adequate contraception. * Ability of subject to understand character and individual consequences of the clinical trial * Written informed consent (must be available before enrolment in the trial) Exclusion Criteria * refusal of the patients to take part in the study * advanced metastatic disease * Patients who have not yet recovered from acute toxicities of prior therapies * Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy- Pregnant or lactating women * Participation in another clinical study or observation period of competing trials, respectively.

Study Objectives Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in colorectal cancer could play an important role in diagnosis, predicting the risk for tumor recurrence, and providing novel target therapy biomarkers. In view of these facts, the investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting human tumor cells of colorectal cancer in normal peripheral blood after cryosurgery with or without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR) method. Conditions: Neoplastic Cells, Circulating Intervention / Treatment: OTHER: Flow cytometry (FCM), OTHER: RT-PCR Location: China Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Age:18-75 * Karnofsky performance status >60 * Diagnosis of colorectal cancer based on histology or the current accepted radiological measures. * Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ * Will receive cryosurgery and/or DC-CIK treatment * Life expectancy: Greater than 3 months * Patients' routine blood test, liver function and kidney function have no obvious abnormalities * Ability to understand the study protocol and a willingness to sign a written informed consent document Exclusion Criteria: * Patients with other primary tumor except colorectal cancer * History of coagulation disorders or anemia

Study Objectives The first-line treatment of anaplastic oligodendrogliomas, radiotherapy exclusive or combined with PCV, will be defined by the pending results of phase III of the EORTC. If the phase II study proposed here achieves its objective, it may help define a new treatment regimen that will be compared to the standard arm from phase III of the EORTC. In addition, this study, by prospectively testing the predictive value of 1p and 19q deletions and of REGF amplification, may allow characterization of patients using these markers. If validated, this characterization can constitute a key element in any therapeutic evaluation (patient stratification), and potentially a major tool for medical decision support in these tumors. Conditions: Oligodendroglioma; Oligoastrocytoma Intervention / Treatment: DRUG: Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically proven oligodendroglioma or anaplastic oligoastrocytoma, newly diagnosed, resulting or not from a low grade glioma * Tumor with measurable contrast enhancement (at least 15 mm in diameter) * Surgical procedure limited to a biopsy or partial excision * In the event of partial excision, an early postoperative check-up (<72 hours) performed at best by MRI, if not by CT, is required. * Time between surgery and inclusion less than or equal to one and a half months (45 days) * Age> 18 years old; <70 * Karnofsky index> 60 * Stable or reduced dose of corticosteroids in the 15 days prior to inclusion * Polynuclear neutrophils> 1500; platelets> 100,000 * Bilirubin <1.25 x UNL; SGOT, SGPT, PAL <2.5 x UNL * Absence of serious uncontrolled pathology * Patient having received and understood the information and having signed the consent Exclusion Criteria: * Presence of GBM foci within the tumor * Absence of evaluable residue after surgery * Previous chemotherapy or radiotherapy * Unsatisfactory expected monitoring conditions * Pregnant or breastfeeding woman; lack of effective contraception if of childbearing age * History of malignant disease (with the exception of CIS of the cervix and basal cell cancer) * Contraindications related to the examination of the I.R.M.

Study Objectives This is a study of pembrolizumab (MK-3475) in participants with previously systemically treated advanced hepatocellular carcinoma (HCC). The primary objectives of this study are to determine 1) Progression-Free Survival (PFS) and 2) Overall Survival (OS) of pembrolizumab plus best supportive care (BSC) compared with placebo plus BSC. The primary hypotheses of this study are: 1) pembrolizumab plus BSC prolongs PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, assessed by Blinded Independent Central Review compared to placebo plus BSC, and 2) pembrolizumab plus BSC improves OS compared with placebo plus BSC. Effective with Amendment 4: Upon study completion, participants are discontinued and may be enrolled in a pembrolizumab extension study, if available. Conditions: Hepatocellular Carcinoma Intervention / Treatment: BIOLOGICAL: Pembrolizumab, DRUG: Placebo, OTHER: Best Supportive Care Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Has a HCC diagnosis confirmed by radiology, histology or cytology (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible). * Has Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach. * Has a Child-Pugh Class A liver score within 7 days of first dose of study drug. * Has a predicted life expectancy >3 months. * Has at least one measurable lesion based on RECIST 1.1 as confirmed by the blinded central imaging vendor. * Has a performance status of 0 or 1 using the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 7 days of first dose of study drug. * Has documented objective radiographic progression during or after treatment with sorafenib or intolerance to sorafenib. * Participants with chronic infection by Hepatitis C Virus (HCV) who are treated (successfully or treatment failure) or untreated are allowed on study. In addition, participants with successful HCV treatment are allowed as long as there are ≥4 weeks between achieving sustained viral response (SVR12) and start of study drug. * Has controlled Hepatitis B Virus (HBV) infection. * Is willing to use an adequate method of contraception for the course of the study through at least 120 days or longer based on local regulation after the last dose of study drug (male and female participants of childbearing potential). * Demonstrates adequate organ function. Exclusion Criteria: * Is currently participating, or has participated in a study of an investigational agent and received study drug, herbal/complementary oral or IV medicine, or used an investigational device within 4 weeks of the first dose of study drug. Participants must also have recovered from associated therapy (i.e., to Grade ≤1 or baseline) and from adverse events (AEs) due to any prior therapy. * Has received sorafenib within 14 days of first dose of study drug. * Has had esophageal or gastric variceal bleeding within the last 6 months. * Has clinically apparent ascites on physical examination. Note: ascites detectable on imaging studies only ARE allowed. * Portal vein invasion at the main portal (Vp4), inferior vena cava, or cardiac involvement of HCC based on imaging. * Has had clinically diagnosed hepatic encephalopathy in the last 6 months. * Has had a solid organ or hematologic transplant. * Has had prior systemic therapy for HCC in the advanced (incurable) setting other than sorafenib, prior to the start of study drug. * Has a known severe hypersensitivity (≥Grade 3) to pembrolizumab, its active substance and/or any of its excipients. * Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. * Has received locoregional therapy to liver (transcatheter chemoembolization \[TACE\], transcatheter embolization \[TAE\], hepatic arterial infusion \[HAI\], radiation, radioembolization, or ablation) within 4 weeks prior to the first dose of study drug. * Has had major surgery to liver or other site within 4 weeks prior to the first dose of study drug. * Has had minor surgery (i.e., simple excision, tooth extraction) ≤7 days prior to the first dose of study drug (Cycle 1, Day 1). * Has not recovered adequately (i.e., Grade ≤1 or baseline) from the toxicity and/or complications from any intervention prior to starting study drug. * Has a diagnosed additional malignancy within 3 years prior to first dose of study drug with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cancers. * Has known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis. * Has a history of non-infectious pneumonitis that required steroids or current pneumonitis. * Has an active infection requiring systemic therapy. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the first dose of study drug through 120 days or longer based on local regulation after the last dose of study drug. * Has received prior immunotherapy including anti-programmed cell death-1 (anti-PD-1), anti-PD-ligand-1 (anti-PD-L1), or anti-PD-L2 agents, or if the participant has previously participated in Merck pembrolizumab (MK-3475) studies. * Has a known history of human immunodeficiency virus (HIV). * Has dual active HBV infection and HCV infection at study entry. * Has received a live vaccine within 30 days of planned start of study drug (Cycle 1, Day 1).

Study Objectives The purpose of this study is to see if using a form of imaging during surgery helps the doctors to guide the placement of radiation catheters more accurately. This method, called "image-guided surgical navigation" may allow the doctors to deliver radiation to the tumor that the patient needs and decrease the amount of radiation delivered to the nearby areas. Conditions: Metastatic or Recurrent Lesions in the Spine, Metastatic or Recurrent Lesions in the Pelvis Intervention / Treatment: RADIATION: Ir-192 high dose rate (HDR) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have histologic proof of a malignancy suitable for radiation therapy. * Patients must have received prior external beam radiation therapy to the region proposed for HDR brachytherapy treatment; evaluation of doses previously delivered to spinal cord/cauda equine, pelvis, and other critical structures (bowel, kidneys, rectum) will be taken into consideration. * If repeat irradiation would exceed any normal tissue constraint set by MSKCC Radiation Oncology Department dose constraint criteria, the patient will potentially be eligible. * If the total prior radiation dose to the cord or pelvis exceeds 100 Gy BED equivalent, the patient will be potentially eligible, where a total of 100 BED Gy equivalent is determined by the biological equivalent dose (BED) calculation; BED = nd(1 + d/α/β), where n = number of fractions and d = dose per fraction; α/β is the constant for spinal cord late effect and equals 2. \[Rades 2005, Nieder 2005, Sahgal 2012\] * KPS ≥ 60 * Age ≥ 18 years old Exclusion Criteria: * Patients who may receive therapeutically effective doses via an external beam approach to the lesion of interest as specified by MSKCC Radiation Oncology Department dose constraint criteria. * Patients with kyphoplasty cement or hardware that would preclude effective catheter placement. * Patients with paraspinal extension of disease with visceral involvement. * Abnormal complete blood count. Any of the following: * Platelet count < 75,000/ml * Hb level < 9gm/dl * WBC < 3.5/ml * Abnormal coagulation profile: INR > 2.5 and/or PTT > 80 * Patients who are on anticoagulation medication that may not be safely held for the procedure (≥ 5 days for antiplatelet agents and warfarin; ≥ 24 hours for low-molecular weight heparin formulations) will be excluded. * Contraindications to general anesthesia

Study Objectives Primary Objectives: 1. To determine the toxicities and maximum tolerated dose (MTD) of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks in subjects with advanced solid tumors. 2. To determine the pharmacokinetic profile of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks. Secondary Objective: 1. To determine the anti-tumor effects of ZIO-101. Conditions: Solid Tumors Intervention / Treatment: DRUG: ZIO-101 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with histological confirmation solid malignancy refractory to conventional standard therapies for their condition. * Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable lesions MUST not have been in a previously irradiated field or injected with biological agents. * Pediatric patients will be eligible at the discretion of the primary investigator. * ECOG performance status score <= 2. * Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive or double barrier device), and must have a negative blood or urine pregnancy test within 1 week before beginning treatment. Sexually active men must also use acceptable contraceptive methods. * Patients must provide written informed consent prior to treatment. * At least four weeks from completion of prior therapy to day 1 of study drug. * Baseline toxicity assessment less than or equal to grade 1 except treatment induced alopecia (NCI Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0). * Evidence of adequate multi-organ functional status as reflected by the following clinical laboratory values: - Serum creatinine <= 2 times the upper normal limit OR a calculated creatinine clearance <= 50 cc/min. - Total bilirubin <= 2 times the upper normal limit. - Alanine aminotransferase (ALT), OR aspartate aminotransferase (AST) <= 3 times the upper limit of normal. * Granulocytes in peripheral blood greater than or equal to 1 x 10(9) per liter, hemoglobin greater than or equal to 8.5 g/dL, and platelets greater than or equal to 50,000 cells/microL. Exclusion Criteria: * Uncontrolled systemic infection (documented with microbiological studies). * Active heart disease as defined by an acute myocardial infarction within the previous 6 months before starting therapy, stable or unstable angina, clinically significant arrhythmia requiring medical management, OR New York Heart Association Classification of Functional Activities. Class 3: Patient has marked limitation in activities due to symptoms, even during less-than-ordinary activity and is comfortable only at rest OR Class 4: Severe limitations. Patient experiences symptoms even while at rest. * Concomitant therapy for solid cancer. * Pregnant subjects and those who are breast-feeding. * History of an invasive second primary malignancy diagnosed within the previous 3 years except for Stage I Endometrial/Cervical Carcinoma or Prostate Carcinoma treated surgically, and non-melanoma skin cancer. * Documented personal or family history of prolonged QT syndrome. * 12 lead electrocardiogram with a corrected QT interval >= 460 milliseconds. * History of confusion or dementia. * History of seizure disorder.

Study Objectives Oxaliplatin-induced neuropathy is a major dose-limiting side effect in patients with colorectal cancer treated with the FOLFOX chemotherapy regimen. Hypersensitivity to cold is the sensory hallmark of oxaliplatin-induced neuropathy, and it can predict the development of long-term neuropathy. In this study, the investigators aim to determine whether intravenous lidocaine can prevent oxaliplatin-induced cold hypersensitivity. Conditions: Neuropathy, Painful, Chemotherapy-induced Peripheral Neuropathy, Colorectal Cancer Intervention / Treatment: DRUG: Lidocaine Hydrochloride, DRUG: Placebo, DRUG: FOLFOX regimen Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Stage III and IV colorectal cancer. * Scheduled for oxaliplatin treatment in mFOLFOX6-based chemotherapy regimen. * Able to understand and willing to sign an IRB-approved written informed consent document. Exclusion Criteria: * Renal insufficiency (defined as calculated Creatinine clearance < 30mL/min) * Moderate to severe liver failure (defined as ALT or AST > 3 times upper limit of normal if no liver metastases are present; ALT or AST > 5 times upper limit of normal if liver metastases are present). * Presence of brain metastases. * Patients with currently uncontrolled cardiac arrhythmias (non-sinus rhythm). * Patients with history of arrhythmias under pharmacological/pacemaker control will be allowed, except if receiving antiarrhythmic medication listed in "contra-indicated medications". * Contraindication or allergy to intravenous lidocaine. * Pre-existing symmetric peripheral painful neuropathy. * Treated with chemotherapy within the past 12 months. * Pregnancy or breastfeeding * Currently treated with any of the following contraindicated medications: Saquinavir, Lopinavir, Amprenavir, Atazanavir, Delavirdine, Mexiletine (and other types of sodium-channel blocker antiarrhythmics), Phenytoin, Carbamazepine, Oxcarbazepine, Lamotrigine, Amiodarone, Dronedarone, Dihydroergotamine, Cimetidine

Study Objectives Acute leukaemia (AL) is an aggressive but potentially curable cancer that can affect women of childbearing age. When a pregnancy is complicated by a diagnosis of AL, clinicians face a complex dilemma: to balance risking the mother's survival through delaying treatment, against the potential harm to the foetus through exposure to cancer drugs. Reports suggest that, providing the first trimester is avoided, successful treatment of AL during pregnancy is possible, and considered safe. However, there is currently no standard approach to treatment of these women. This observational study aims to monitor and record the current treatment and outcomes of patients diagnosed with acute leukaemia during or prior to pregnancy. Patients will receive the treatment recommended by their doctor, the study will not alter the treatment pathway of participants. This study will establish a new research database of Leukaemia in Pregnancy, initially collecting data from cases since August 2009, and any new cases that are diagnosed during the current funding period. The initial planned analyses from this dataset will enable more robust, evidence-based recommendations to be made on how to monitor and manage these patients, and will add value to and improve the existing British Committee for Standards in Haematology (BCSH) guidelines, which were largely derived from expert opinion. This should enable healthcare professionals to have greater confidence in managing these patients, leading to a more standardised approach to providing high quality care. The study will benefit National Health Service (NHS) Trusts and patients across the United Kingdom (UK) through more informed clinical decision making with regards to the care they receive. It will also provide an important data resource which researchers can apply to use in further analyses, with plans to continue data collection if further funding is obtained. Conditions: Acute Leukemia Location: United Kingdom Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Women who have a diagnosis of acute leukaemia (AL) or high-risk myelodysplasia (MDS) in pregnancy, or who have later conceived after receiving previous treatment for either AL or high-risk MDS. Exclusion Criteria: * Pregnant women not meeting the inclusion criterion.

Study Objectives Despite the fact that a substantial response rate may be obtained in small-cell lung cancers (using double-drug chemotherapy: cisplatin-etoposide, PE), a cure remains an exception. More aggressive regimens remain controversial and recent attempts at increasing dose-intensity have been restricted to patients with a more favourable presentation. Bevacizumab is a humanized monoclonal antibody which binds to VEGF (Vascular Endothelial Growth Factor). In association with double-drug standard chemotherapies, it has been proven that bevacizumab can improve survival of previously untreated advanced non-small-cell lung cancers (NSCLC), compared to chemotherapy without bevacizumab). Such promising effects on NSCLC deserve to be tested on small-cell lung cancers. In this trial (IFCT-0802), standard chemotherapy (PCDE or PE) will be compared to experimental treatment (PCDE or PE + bevacizumab 7.5 mg/kg) for previously untreated SCLC patients. Conditions: Small Cell Lung Cancer Intervention / Treatment: DRUG: Standard Chemotherapy (PCDE or PE), DRUG: Experimental Treatment (PCDE or PE + bevacizumab), DRUG: Prerandomization Chemotherapy (PCDE or PE) Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria (must be checked at the inclusion, week -8): * Small-Cell Lung Cancer histologically or cytologically proved * Extended disease as defined by Veteran's Administration Lung Cancer Group (VALG) * At least one unidimensionally measurable lesion (RECIST criterion) * Age between 18 and 75 years * Weight loss < 10% for the last three month * Performance Status (PS)≤ 2 * Creatininemia < 110 µmol/L and creatinin clearance > 60 mL/min * Neutrophils ≥ 1,500/µL and platelets ≥ 100,000/µL * Bilirubin ≤ 1.5 x normal value * Transaminases, Alkaline Phosphatase ≤ 2.5 x ULN excepted in case of liver metastasis (5xULN) * Left ventricular ejection fraction (measured by echocardiographic or isotopic method) > 50% if PCDE is planned * Electrocardiogram without uncontrolled coronaropathy * Signed informed consent Randomization Criteria (to be checked during the randomization (week 0)): * Partial or complete tumoral response as defined by RECIST * All chemotherapy-induced toxicities decreased to level ≤ 2 as defined by NCI CTC VS 3 (except for alopecia) * Inclusion criteria concerning creatininemia, clearance, neutrophils, platelets, transaminases, alkaline phosphatases and left ventricular ejection fraction must be checked again Exclusion Criteria: * Non-Small-Cell Lung Cancer or mixed cancer (small-cell / non-small-cell) * Previous antitumoral treatment of the small-cell lung cancer (chemotherapy, radiotherapy, immunotherapy, surgery) * Non-extended disease as defined by VALG * Natremia < 125 mmol/L * Hypercalcemia whereas a corrective treatment * Pathology contra-indicating the hyper-hydration * Hemoptysis in the last three months * Tumor invading large vessels or invading the proximal trachea-bronchial tree (visible at the medical imagery). Investigator or radiologist must reject tumors adjoining, merging or extending to large vessel's lumen (for example : pulmonary artery, superior vena cava) * Symptomatic cerebral or meningeal metastasis * Other cancer in progress or medical history of cancer in the five last years (excepted basal cell carcinoma or in situ cervical cancer of the uterus. * Important surgical intervention (including surgical biopsy), traumatic lesion during 28 days before starting the treatment, or anticipation of an important surgical intervention during the study * Minor surgical intervention, including implanting permanent catheter during the 24 hours before the first administration of bevacizumab * Unhealed wound, evolutive gastroduodenal ulcer, fractured bone * Medical history of abdominal fistula, trachea-oesophageal fistula, of another type with a severity rank of 4, gastrointestinal perforation or intraabdominal abscess during 6 month before inclusion * Ongoing or recent use of aspirin (during 10 days before the first administration of bevacizumab) (>325 mg/day) or use of another platelet aggregation inhibitor (dipyridamole, ticlopidine, clopidogrel > 75 mg/day), or ongoing or recent use of a therapeutic dose (during 10 days before the first administration of bevacizumab) of anticoagulant or thrombolytic drugs per os or in parenteral injection. Prophylactic use of anticoagulant drug is allowed * Medical history or genetic predisposition to bleeding or coagulopathy * Clinically significative cardiac disease: infarct or CVA during 6 month before inclusion, unstable angina, congestive cardiac failure level > II as defined by New York Heart Association (NYHA) or cardiac arrythmia needing a specific treatment which risk to interfere with the study, or uncontrolled arrythmia. * Known allergy or hypersensibility to monoclonal antibodies (bevacizumab), to chinese hamster ovary cells or to any humanized or recombinant antibody * Uncontrolled high blood pressure (systolic pressure > 150 mm Hg and/or diastolic pressure > 100 mm Hg), with or without hypotension treatment. Patients presenting an high blood pressure are eligibles if their treatment can decrease their blood pressure to the values required by the protocol. * Severe ongoing infectious disease or fever > 38.5°C or evidence of any other pathology, organic or neurologic functions deterioration, physical examination or laboratory result which cause suspicion of a disease which contra-indicate use of any studied treatment. * Woman with a positive pregnancy test or who has not made a pregnancy test (unless pregnancy risk can be excluded) * Lactating woman * Sexually active woman who don't use hormonal or mechanical contraceptive method or sexually active man who has a sexually active partner who don't want to use an effective contraceptive method during the course of the study and during the 6 months after last treatment administration * Patient who as already been included and treated in the present study * Patient who participate or who has participated in another study during 4 weeks before treatment administration * Patient who receive a previous antiangiogenic treatment (experimental or commercial : bevacizumab, thalidomide, CP-547632, sunitinib, sorafenib...) * Geographical or psychological condition which not allowed a good comprehension or compliance to protocol * Liberty deprived patient

Study Objectives The purpose of this study is to determine if an alternative imaging protocol done at the time of radiotherapy treatments for patients with breast cancer can improve accuracy in patient set-up. Conditions: Breast Cancer Intervention / Treatment: RADIATION: Anterior electronic portal images (EPI) Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * All patients (male or female) receiving tangential breast/chest wall radiotherapy only, or three or four field breast/chest wall and nodal radiotherapy will be eligible. Exclusion Criteria: * Those patients receiving partial breast treatment, those patients requiring an electron match field, those on another breast cancer radiotherapy trial, those who require radiotherapy using deep inspiration breath hold or multi-field intensity modulated radiotherapy, and all non-breast cancer patients will be excluded.

Study Objectives To show if one MRI contrast agent is better than another one in the diagnosis of malignant breast lesions compared to histopathology Conditions: Breast Cancer Intervention / Treatment: DRUG: Multihance, DRUG: Magnevist Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: DIAGNOSTIC Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: TRIPLE

Inclusion Criteria: * Provides written informed consent * Female * Age 18 years or older * Suspicious or known breast lesion based on results from mammography or ultrasound * Planned to undergo histological diagnosis of breast lesion by having a non surgical biopsy or breast surgery within 30 days after the MRI exam Exclusion Criteria: * Body weight > 100 kg * Pregnant or lactating * Server or end-stage organ failure * Moderate to severe renal impairment * Undergoing radiotherapy or completed radiotherapy in the last 18 months * Chemotherapy within 6 months of the 1st MRI exam

Study Objectives The purpose of this study is to investigate whether tocotrienol can improve the effect and reduce the side effects of standard chemotherapy before operation for breast cancer. Conditions: Breast Cancer Intervention / Treatment: DRUG: Epirubicin 90 mg/m2 iv, DRUG: Cyclophosphamide 600 mg/m2 iv, DRUG: Docetaxel 100 mg/m2 iv OR paclitaxel 80 mg/m2 iv, DRUG: Trastuzumab 8 mg/kg iv saturation, then 6 mg/kg iv (HER2 positive patients only), DRUG: Pertuzumab 840 mg iv saturation, then 420 mg iv (selected HER2 positive patients only), DIETARY_SUPPLEMENT: Tocotrienol 300 mg x 3 daily Location: Denmark Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Women with histologically verified breast cancer (adenocarcinoma) * Age ≥ 18 years. * Neoadjuvant treatment indicated according to departmental guidelines * PS 0-2 and suited for surgery. * Normal heart function, LVEF ≥ 50% by MUGA/ECHO in patients receiving neoadjuvant trastuzumab * Normal bone marrow function: Hemoglobin ≥ 6 mmol/l; ANC ≥ 1.5x10\^9/l; Thrombocytes ≥ 100x10\^9/l. * Normal liver function: Bilirubin ≤ 1.5 x upper level of normal, ALAT ≤ 2.5 x upper level of normal, BASP ≤ 2.5 x upper level of normal. * Normal kidney function: Creatinine ≤ upper level of normal. In case of increased creatinine, measured/calculated GFR must be ≥ 50 ml/min. * Fertile women must present a negative pregnancy test and use a safe contraceptive during and 3 months after the treatment. Intrauterine device without hormone is considered safe. * Written and orally informed consent Exclusion Criteria: * Bilateral breast cancer or suspected dissemination. Verified by bilateral mammography, bone scintigraphy, chest and abdomen CT, and PET-CT. * Pregnant and breastfeeding women * Mental or social conditions that will prevent treatment or follow-up * Other simultaneous experimental treatment * Immunosuppressive treatment (other than prednisolone during neoadjuvant chemotherapy) * Vitamin or nutritional supplements (other than multivitamin tablet and calcium tablet with vitamin D) * Active or latent viral/bacterial infection * Rheumatoid arthritis or other autoimmune disease * Other malignant disease within the past 5 years excl. non-melanoma cancer of the skin and carcinoma in situ cervicis uteri. * Previous treatment with docetaxel, paclitaxel, epirubicin, cyclophosphamide, trastuzumab, pertuzumab or tocotrienol * Hypersensitivity to any of the active or auxiliary substances

Study Objectives This two part study will evaluate the safety and tolerability of MK0429 in addition to assessing it's pharmacokinetic profile and pharmacodynamic response. Conditions: Prostatic Neoplasms Intervention / Treatment: DRUG: Comparator: MK0429, DRUG: Comparator: MK0429, DRUG: Comparator: MK0429, DRUG: Comparator: MK0429 Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Eligible patients must have: * Prostate cancer * Bone metastases without symptoms * Lack of response to hormone therapy as evidenced by a rising PSA or clinical progression Exclusion Criteria: * Prostate cancer-related bone pain * Previously received bisphosphonate therapy (e.g. zoledronate) * Received any investigational treatment within the last 30 days

Study Objectives A study to assess the activity of Iressa in patients who's prostate cancer has recurred, and who have rising PSA levels Conditions: Prostate Cancer Intervention / Treatment: DRUG: Gefitinib Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Prostate cancer diagnosis * no evidence of metastasis * Age 18 or older Exclusion Criteria: * Prior chemotherapy for recurrent prostate cancer * Radiotherapy completed within 28 days of starting the study * Incomplete healing from prior cancer or other major surgery

Study Objectives To test whether pre - disinfection skin scrub with 4% chlorhexidine gluconate is more effective on the reduction of surgical site microbial colonization and subsequent infection than is normal saline. Conditions: Liver Tumors Intervention / Treatment: DRUG: Chlorhexidine gluconate, DRUG: 0.9% Sodium Chloride Location: Taiwan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * patient who received elective hepatectomy for liver tumors Exclusion Criteria: * patients who were younger than 18 years of age * patients who had a history of radiation to the operative sites * patients who received repeat hepatectomy * patients who had a history of allergy to CHG, ethyl alcohol or povidone - iodine * patients whose tumors were metastatic cancers * patients who had a preoperative active remote infection

Study Objectives This is an open-label, single-arm, phase II, multicenter study designed to evaluated the efficacy and safety of atezolizumab in combination with bevacizumab in PD-L1-selected patients with Stage IIIB-IV Non-Squamous NSCLC harbored EGFR mutation after EGFR TKI therapy. Conditions: Carcinoma, Non-Small-Cell Lung Intervention / Treatment: DRUG: Atezolizumab, DRUG: Bevacizumab Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Life expectancy ≥ 10 months * Histologically or cytologically confirmed stage IIIB, IIIC, or IV non-squamous NSCLC. Patients with tumors of mixed histology are eligible if the major histological component appears to be non-squamous. * No prior treatment for Stage IIIB, IIIC, or IV non-squamous NSCLC, with the following exceptions: Patients with a sensitizing mutation in the EGFR gene must have experienced disease progression or were intolerant to treatment with one or more EGFR TKIs. Patients who have progressed on or were intolerant to first-line osimertinib or other thirdgeneration EGFR TKIs are eligible. Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs, and who have no evidence of the EGFR T790M mutation after TKI therapy are eligible. Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs and who have evidence of the T790M mutation must have also progressed on or were intolerant to osimertinib to be eligible. * TKIs approved for treatment of NSCLC discontinued >7 days prior to enrollment. * Measurable disease per RECIST v1.1. PD-L1 expression of ≥1% as documented through central testing of a representative tumor tissue specimen either from previously obtained archival tumor tissue or tissue obtained from a biopsy at screening * ECOG Performance Status of 0-1 * Adequate hematologic and end-organ function * Negative HIV test at screening * Negative hepatitis B surface antigen (HBsAg) test at screening * Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive total HBcAb test. * Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test. * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs. * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm. Exclusion Criteria: * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments * History of leptomeningeal disease * Prior chemotherapy or other systemic therapy for stage IIIB, IIIC, or IV disease * Active or history of autoimmune disease or immune deficiency * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan * Active tuberculosis * Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina * History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death * Prior allogeneic stem cell or solid organ transplantation * Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab * Current treatment with anti-viral therapy for HBV * Treatment with investigational therapy within 28 days prior to initiation of study treatment * Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies * Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment * Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment * History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins * Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or bevacizumab formulations * Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab, 6 months after the final dose of bevacizumab * Prior history of hypertensive crisis or hypertensive encephalopathy * Significant vascular disease within 6 months prior to initiation of study treatment * History of Grade ≥ 2 hemoptysis within 1 month prior to enrollment * Evidence of bleeding diathesis or coagulopathy. Current or recent use of aspirin, clopidogrel or treatment with dipyramidole, ticlopidine, or cilostazol * Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes that has not been stable for > 2 weeks prior to enrollment * History of stroke or transient ischemic attack within 6 months prior to enrollment * Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of bevacizumab * History of abdominal or tracheosphageal fistula or gastrointestinal perforation within 6 months prior to enrollment * History of intra-abdominal inflammatory process within 6 months prior to initiation of study treatment, including but not limited to active peptic ulcer disease, diverticulitis,or colitis * Clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding * Evidence of abdominal free air not explained by paracentesis or recent surgical procedure * Proteinuria * Clear tumor infiltration into the thoracic great vessels is seen on imaging * Clear cavitation of pulmonary lesions is seen on imaging

Study Objectives The purpose of the trial is to investigate, if remote ischemic preconditioning reduces the risk of complications in patients undergoing resection of head and neck cancer and immediate reconstruction with autologous free tissue transfer. Remote ischemic preconditioning is a treatment, which is carried out by inducing brief episodes of upper arm occlusion using an inflatable tourniquet. Blood samples will be taken during the operation and postoperatively to evaluate the effects of remote ischemic preconditioning. These blood samples will be analyzed for clotting properties and markers of inflammation. Furthermore, effects on the blood supply of the transferred tissue flap will be measured by infrared thermography. Effects on surgical complication rates will be obtained by clinical follow-up and patient chart review. Conditions: Head and Neck Neoplasms Intervention / Treatment: PROCEDURE: Remote ischemic preconditioning, PROCEDURE: Sham Location: Denmark Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Histologically verified or clinically suspected malignant tumor in the oral cavity, maxillae, mandible, pharynx, larynx, and/or esophagus. * Will undergo tumor resection and immediate free flap reconstruction at Aarhus University Hospital, Denmark. * The reconstruction is planned with a single free flap. Exclusion Criteria: * Arterial and/or venous thromboembolism within the last three months. * The reconstruction is planned with more than one free flap.

Study Objectives The purpose of this study is to find out what effects a new drug SB939 has on you and your sarcoma. This research is being done because there is a need for better treatment options for advanced or recurring sarcoma. SB939 has been shown to shrink tumours in animals and some people and seems promising but it is not clear if it has any positive effects in sarcoma. Conditions: Metastatic Sarcoma Intervention / Treatment: DRUG: SB939 Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with histologically diagnosed sarcomas that are associated with chromosomal translocation producing a fusion transcription factor oncogene. * Patients must have measurable disease. * A tissue block from primary or metastatic tumor must be available for confirmation of diagnosis, translocation subtype and correlative studies. * Up to 1 prior chemotherapy regimen in the metastatic setting is permitted providing 28 days have elapsed. * Prior radiation permitted provided a minimum of 28 days have elapsed. * Surgery permitted provided at least 3 weeks have elapsed. * Prior hormone therapy permitted. * Patients must have life expectancy ≥ 12 weeks. * Metastatic or locally recurrent disease incurable with standard treatment. * Acceptable end-organ function. ECOG 0, 1 or 2. * granulocytes ≥1.5x10/9/L * platelets ≥100x10/9/L * bilirubin ≤UNL * potassium ≤UNL * calcium, magnesium within normal limits * AST, ALT ≤2.5 x UNL * serum creatinine ≤UNL or creatinine clearance ≥50mL/min * QTc ≤450m sec * LVEF ≥50% * Troponin I or T ≤ UNL Exclusion Criteria: * Cardiac exclusions; Patients with any preexisting uncontrolled cardiac condition. * History of myocardial infarction at any time in the past. * Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 5 years. * Patients with documented CNS metastases, unless adequately treated with radiation at least 30 days prior to enrollment. Patients cannot have concurrent anti-convulsants or dexamethasone for control of symptoms. Patients with leptomeningeal disease, even with treatment, cannot be enrolled due to generally poor prognosis. * Inability to take oral medication. Patients must be able to swallow SB939 capsules and have no gastrointestinal abnormalities (e.g. bowel obstruction or previous gastric resection) which would lead to inadequate absorption of SB939. * Previous treatment with an HDAC inhibitor. * Treatment with another investigational therapy or other anticancer therapy within 28 days prior to study entry. * Known HIV, hepatitis B or hepatitis C infections. * Dysrhythmic drugs - use of agents with a known risk of Torsades De Pointe is not permitted during the study. A comprehensive list can be found at http://torsades.org. * Presence of any chronic medical condition or comorbidity such as pulmonary disease, active CNS disease, active infection, psychiatric condition, or laboratory abnormality that may increase the risks associated with study participation/study drug administration or may interfere with the interpretation of study results. * Women or men who are not sterile unless they use an adequate method of birth control. Female patients that are post-menopausal for at least 12 months or are surgically sterile are considered sterile.

Study Objectives Aim: to observe the graft versus tumor effect of Pegylated Interferonα-2b in patients with hematological malignancies relapsed after allogeneic hematopoietic stem cell transplantation (alloHSCT) Patients: patients relapsed after alloHSCT, men and women aged 14-60 years, without vital organ dysfunction or ongoing graft-verus-host disease (GVHD). Number of subjects: 50, Single center, one group, prospective. Drug: pegylated interferon alpha-2b (Peg Intron®; Schering-Plough) 1\~1.5ug/kg qw, until occurrence of grade II or higher grade of acute GVHD, or no response to treatment after 8 doses of treatments. Conditions: Hematological Neoplasms, Recurrence Intervention / Treatment: DRUG: Peg interferon alfa-2b Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age 14-60 years, male or female * Allo-HSCT recipients with malignant hematological diseases * Disease relapse after allo-HSCT, including hematological relapse, molecular relapse * Able to provide written informed consent and to comply with all study procedures Exclusion Criteria: * Pregnant or nursing woman * Cardiac ejection factor < normal lower limit * Active acute or chronic GVHD with immunosuppressant treatment * Known hypersensitivity or allergy to interferon * Patient might develop serious complications according to investigator's experiences * Patient is undergoing other experimental medication

Study Objectives Due to colorectal cancer is the fourth most common malignancy in the world. Some patients had present locally advance stage and need to preoperative concurrent chemoradiation (CCRT) before radical surgery. But predictor for pathologic complete response (pCR) after preoperative CCRT remain unclear. Objectives: To identify possible factor for predict of pCR of rectal cancer after preoperative CCRT. Conditions: Rectum Cancer Location: Thailand Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * rectal cancer and received preoperative chemoradiation Exclusion Criteria: * distant organ metastasis * previous colorectal surgery

Study Objectives This is a prospective diagnostic performance study which compares three new imaging methods with the current standard imaging method for the diagnosis of metastatic lymph nodes. Conditions: Surgically Staged Endometrial and Cervical Carcinoma, Cervical Cancer: Invasive Disease, FIGO Stage 1B1 or Higher, Endometrial Cancer, Stage 1A With Myometrial Invasion or Any Higher Stage and Grade 3, Stage 1A With Myometrial Invasion or Any Other Higher Stage and Serous Papillary or Clear Cell Sub-types, Stage II Disease or Above and Any Histology Grade Intervention / Treatment: DIAGNOSTIC_TEST: Diffusion-weighted MRI, DIAGNOSTIC_TEST: Fluorodeoxyglucose-18-PET/CT, DIAGNOSTIC_TEST: Fluoro-ethyl-coline-PET/CT Location: United Kingdom Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Females 18 years or older; (no upper limit). * Patients with histologically confirmed cancer of the cervix or endometrium. 1. In patient with cervix cancer, there must be confirmation of invasive disease; FIGO stage 1B1 or higher FIGO stage demonstrated clinically and/or on MRI. In patients with advanced disease being considered for chemoradiotherapy treatment, patients may be considered for entry if nodal lymphadenectomy is being used to inform radiotherapy planning; 2. In patients with endometrial cancer, a) stage 1A with myometrial invasion or any higher stage and grade 3 b) stage 1A with myometrial invasion or any other higher stage and serous papillary or clear cell sub-types 3. stage II disease or above and any histology grade The MDT decision may be based on the combination of tumour characteristics on histology, clinical and imaging findings. * No contra-indication to FDG-PET/CT, FEC-PET/CT or MRI. * Fit for surgical lymphadenectomy, as determined by the local MDT. The patient should also be considered fit for extended field radiotherapy in cases where lymphadenectomy is being undertaken to inform radiotherapy planning. The extent of lymph node dissection will be made by the local multidisciplinary team, based on the presence of risk factors for lymph node metastases, according to the protocol. Patients must be considered fit to undergo lymph node dissection. * Able and willing to give written informed consent and to comply with the study protocol procedures Exclusion Criteria: * Known contra-indication to MRI or PET/CT scan. * Known allergy to FDG or FEC. * Not considered fit for lymphadenectomy (open or laparoscopic) or, where appropriate, radiotherapy, as determined by the local MDT. * If the patient is pregnant or breast-feeding. * Females of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control) from the time consent is signed until 6 weeks after the last PET/CT scan unless undergoing hysterectomy. Note: subjects are not considered of childbearing potential if they are surgically sterile (they have undergone bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal * Females of childbearing potential must have a negative pregnancy test within three weeks prior to being registered for the study. * Participation in another Clinical Trial of an Investigational Medicinal Product (CTIMP). If patient's have recently completed a CTIMP trial they must have had their last dose(s) of study drug prior to their first imaging procedure on the MAPPING study. * Participation in another clinical trial (CTIMP or non-CTIMP) where the protocol contains imaging procedures that would occur during the MAPPING study. * Medical or psychiatric illness, which makes the patient unsuitable or unable to give informed consent.

Study Objectives To evaluate the safety of reoperation in patients with renal tumors who have ipsilateral tumor recurrence after nephron-sparing partial nephrectomy. Conditions: Renal Cell Carcinoma, Robotic Surgical Procedures Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * ipsilateral local rRCC (any recurrence in the ipsilateral kidney and retroperitoneum) Exclusion Criteria: * With distant metastasis; * Lacking essential sugery information.

Study Objectives The purpose of the study is to compare the intratumoral biodistribution of FAZA and F-miso in patients with non-small cell lung cancer and correlate the results of PET scans with immunohistochemistry. Conditions: Non-small Cell Lung Cancer Intervention / Treatment: DEVICE: Miso PET scan, DEVICE: FAZA PET scan Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: OTHER Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Male or female * More than 18 years old * Patient with non-small cell lung cancer (histologically proved) * PS inferior or equal to 1 (good general state) * Patient must have surgery for their non-small cell lung cancer * Stage of tumor Superior or equal to 2a without metastasis * Tumoral fixation with 18-FDG-PET superior to mediastinal background noise * Written inform consent Exclusion Criteria: * Histology other than primitive non-small cell lung cancer * In situ form at the histological study * Patient without evaluable target * No fixation on the pretherapeutic FDG-PET scan * PS Superior or equal to 2 * neoplastic disease (less than 2 years or progressive) * Pregnant woman or child-bearing * Patient Under guardianship or curators

Study Objectives The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma. Conditions: Melanoma Intervention / Treatment: BIOLOGICAL: Nivolumab/rHuPH20, BIOLOGICAL: Nivolumab Location: Spain, United States, Italy, Poland, Belgium, United Kingdom, Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Stage IIIA/B/C/D or Stage IV melanoma and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins * Complete resection performed within 12 weeks prior to randomization or treatment assignment * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 Exclusion Criteria: * History of uveal or mucosal melanoma * Untreated/unresected CNS metastases or leptomeningeal metastases * Active, known or suspected autoimmune disease * Serious or uncontrolled medical disorder 4 weeks prior to screening * Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization or treatment assignment. Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible * Prior immunotherapy treatments for any prior malignancies are not permitted Other protocol-defined inclusion/exclusion criteria apply

Study Objectives This laboratory study is looking into biomarkers in samples from younger patients with acute myeloid leukemia. Studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer Conditions: Childhood Acute Monoblastic Leukemia (M5a), Childhood Acute Monocytic Leukemia (M5b), Childhood Acute Myeloblastic Leukemia Without Maturation (M1), Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies, Childhood Acute Myelomonocytic Leukemia (M4) Intervention / Treatment: OTHER: laboratory biomarker analysis Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Frozen bone marrow aspirates obtained from childhood acute myeloid leukemia (AML) patients possessing defined cytogenetic mutations; AML1-ETO or inv(16) * Samples of cytogenetically normal AML cases obtained from the University of Alabama at Birmingham (UAB) as controls

Study Objectives This randomized phase I trial studies the side effects and best dose of dinaciclib and Akt inhibitor MK2206 in treating patients with pancreatic cancer that cannot be removed by surgery. Dinaciclib and Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Conditions: Pancreatic Adenocarcinoma, Recurrent Pancreatic Carcinoma, Stage III Pancreatic Cancer AJCC v6 and v7, Stage IV Pancreatic Cancer AJCC v6 and v7, Unresectable Pancreatic Carcinoma Intervention / Treatment: DRUG: Akt Inhibitor MK2206, DRUG: Dinaciclib, OTHER: Laboratory Biomarker Analysis, OTHER: Pharmacological Study Location: Canada, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients must have a histologically confirmed, unresectable pancreatic adenocarcinoma * Patients must have already received or refused 1st-line treatment * Measurable disease will be required; biopsiable disease will be required * Eastern Cooperative Oncology Group (ECOG) performance status =< 1 * Life expectancy of greater than 16 weeks * Leukocytes >= 3,000/mcL * Absolute neutrophil count >= 1,500/mcL * Platelets >= 100,000/mcL * Total bilirubin =< 1.5 institutional upper limit of normal (IULN) * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \[SGPT\]) =< 2.5 X IULN if no liver metastasis or =< 5 X IULN if liver metastases are present * Creatinine not to be above IULN OR creatinine clearance >= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of MK-2206 and dinaciclib administration * Patients must be able to swallow whole tablets (for MK-2206); nasogastric or gastrostomy (G) tube administration is not allowed; tablets must not be crushed or chewed * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered to =< grade 1 (or =< tolerable grade 2 for neuropathy) adverse events due to agents administered more than 4 weeks earlier * Patients who are receiving any other investigational agents * Patients with known brain metastases should be excluded from this clinical trial * History of allergic reactions attributed to compounds of similar chemical or biologic composition to dinaciclib or to MK-2206 * Patients receiving any medications or substances that are strong inhibitors/inducers, sensitive substrates, or substrates with a narrow therapeutic index of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or permeability glycoprotein (P-gp) are ineligible; caution should be exercised when dosing dinaciclib and/or MK-2206 concurrently with CYP3A4 or P-gp substrates, inhibitors/inducers; if subjects are taken off a forbidden medicine, a one-week washout is required for inhibitors and two weeks for inducers; subjects on Coumadin are eligible but more frequent monitoring of the international normalized ratio (INR) (weekly during the first cycle, then at least each cycle thereafter) is recommended; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product * Patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK-2206, but the hyperglycemia should be well controlled before the patient enters the trial (glycosylated hemoglobin \[Hba1c\] < 7.5) * Concurrent medications associated with a risk of corrected QT (QTc) prolongation and/or torsades de pointes are not allowed; those medications listed as reported but lacking substantial evidence for causing QTc prolongation and torsades de pointes will be allowed, although if an alternative medication can be substituted, that would be preferable; for this study, a baseline electrocardiogram (EKG) will be performed and will be repeated during cycle 1 and then every 3 cycles while on treatment * Patients with current evidence of significant cardiovascular disease (New York Heart Association class III or IV cardiac disease), symptomatic congestive heart failure, dilated/hypertrophic or restrictive cardiomyopathy, myocardial infarction (within the past 6 months), unstable angina, unstable arrhythmia or a need for anti-arrhythmic therapy (use of medications for rate control for atrial fibrillation is allowed such as calcium channel blockers and beta-blockers, if stable medication for at least last month prior to initiation of MK-2206 treatment and medication not listed as causing torsades de pointes), or evidence of acute ischemia on electrocardiogram (ECG); marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval > 450 msec\*; long QT syndrome; the required use of concomitant medication that may cause torsades de pointes or may cause a significant prolongation of the QTc * Note: Due to difficulties assessing QTc in patients with heart block, they may be eligible if deemed safe by a cardiologist * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MK-2206 and/or dinaciclib * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible * Clinically significant ascites

Study Objectives In this Phase II trial, the investigators will evaluate the combination of gemcitabine, carboplatin, and panitumumab in the treatment of patients with metastatic triple-negative breast cancer. In addition, to assess the efficacy of this combination, tumor tissue will be examined for the presence of various markers, including K-ras and PI3K-activating mutations, EGFR, PTEN, and p53. Correlation of tumor response with marker expression may define a patient subset that is particularly responsive to treatment with a panitumumab-containing combination. Conditions: Metastatic Breast Cancer Intervention / Treatment: DRUG: Panitumumab, DRUG: Carboplatin, DRUG: Gemcitabine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Female patients >=18 years of age. * Histologically or cytologically confirmed diagnosis of unresectable locally advanced or stage IV breast cancer. * No more than 1 prior treatment regimen for metastatic breast cancer. * Estrogen receptor and progesterone receptor negative (defined as <10% staining by IHC). * Paraffin-embedded tumor tissue (from the primary tumor or metastasis) for biomarker testing. (In the absence of paraffinembedded tissue, unstained paraffin-embedded tumor slides are acceptable). * Measurable disease, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) guidelines * HER2 negative tumors. HER2 negativity must be confirmed by one of the following: * FISH-negative (FISH ratio <2.2), or * IHC 0-1+, or * IHC 2-3+ AND FISH-negative (FISH ratio <2.2) * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1. * Absolute neutrophil count (ANC) >=1.5 × 109/L; platelet count >=100 × 109/L; hemoglobin >=9.0 g/dL. * Creatinine <=1.5 mg/dL, or creatinine clearance >=40 mL/min (as calculated by the Cockcroft-Gault method, as follows: Female creatinine clearance = (140 - age) × (weight in kg) × 0.85 (serum creatinine × 72) * Adequate hepatic function, defined as follows: total bilirubin <=1.5 x ULN; aspartate aminotransferase (AST) <=3 × ULN (or <= 5 x ULN if liver metastases); alanine aminotransferase (ALT) <=3 x ULN (or <=5 x ULN if liver metastases). * Magnesium level >= the institutional lower limit of normal (LLN). * Women of childbearing potential must agree to use adequate contraception (per institutional standard of care) during treatment and until 6 months after the last administration of investigational products. Exclusion Criteria: * Patients with brain metastases are not eligible. * History of another primary cancer, with the exception of the following: * Curatively treated in situ cervical cancer; * Curatively resected non-melanoma skin cancer; * Other primary solid tumor curatively treated with no known active disease present and no treatment administered for >=5 years prior to study enrollment. * History of interstitial lung disease (e.g., pneumonitis, pulmonary fibrosis), or any evidence of interstitial lung disease on the CT scan of the chest performed at the baseline visit. * Prior anti-EGFR antibody therapy (e.g., cetuximab), or treatment with small-molecule EGFR inhibitors (e.g., gefitinib, erlotinib, lapatinib). * Radiotherapy <=14 days prior to study enrollment. Any acute effects of radiotherapy must be resolved prior to the administration of study drugs. * Systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved proteins/antibodies (e.g., bevacizumab) <=21 days prior to study enrollment. * Prior therapy with gemcitabine or carboplatin in the metastatic setting is not permitted. Patients who received gemcitabine or carboplatin as part of adjuvant therapy are eligible, as long as recurrence was first documented >12 months after the last exposure to the drug(s). * Major surgery within 28 days or minor surgery within 14 days of study enrollment. * Requirement of chronic use of immunosuppressive agents (e.g., methotrexate, cyclosporine). * Any investigational agent or therapy <=30 days prior to study enrollment. * Uncontrolled or intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. * History of any medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with the study participation or administration of the investigational products, or that may interfere with the interpretation of the results. * Unwillingness or inability to comply with study requirements. * Women who are pregnant or breastfeeding. * Patients with known human immunodeficiency virus (HIV), hepatitis C virus, and/or acute or chronic hepatitis B virus infection.

Study Objectives RATIONALE: Palliative care teaching sessions may be more effective than standard care in improving caregiver burden, caregiver skills preparedness, quality of life, and distress in family caregivers of patients with non-small cell lung cancer. PURPOSE: This clinical trial is studying the effects of palliative care teaching sessions in family caregivers of patients with non-small cell lung cancer. Conditions: Lung Cancer Intervention / Treatment: OTHER: educational intervention, OTHER: questionnaire administration, PROCEDURE: end-of-life treatment/management, PROCEDURE: psychosocial assessment and care, PROCEDURE: quality-of-life assessment Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * The primary family caregiver as identified by a patient with early or late stage non-small cell lung cancer (NSCLC) participating in Project 1 and 2 * Patients having been accrued to project 1 or project 2

Study Objectives This is a Phase 1, multiple dose, ascending-dose escalation study and expansion study designed to define a maximum tolerated dose and/or recommended dose of XmAb22841 monotherapy and in combination with pembrolizumab; to assess safety, tolerability, pharmacokinetics, immunogenicity, and anti-tumor activity of XmAb22841 monotherapy and in combination with pembrolizumab in subjects with select advanced solid tumors. Conditions: Melanoma, Cervical Carcinoma, Pancreatic Carcinoma, Triple Negative Breast Cancer, Hepatocellular Carcinoma, Urothelial Carcinoma, Squamous Cell Carcinoma of the Head and Neck, Nasopharyngeal Carcinoma, Renal Cell Carcinoma, Non-small Cell Lung Carcinoma, Small Cell Lung Carcinoma, Gastric or Gastroesophageal Junction Adenocarcinoma, Advanced or Metastatic Solid Tumors, Prostate Carcinoma, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Intrahepatic Cholangiocarcinoma, Squamous Cell Anal Cancer, Squamous Cell Penile Carcinoma, Squamous Cell Vulvar Carcinoma, Colorectal Carcinoma, Endometrial Carcinoma Intervention / Treatment: BIOLOGICAL: XmAb®22841, BIOLOGICAL: Pembrolizumab (Keytruda®) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: PART A (Dose Escalation Cohorts) * All subjects' cancer must have progressed after treatment with all available therapies that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment. * All subjects must have adequate archival tumor, or give consent to a fresh tumor biopsy. * Subjects have an ECOG performance status of 0-1. * Subjects in monotherapy and combination therapy cohorts must have histologically or cytologically confirmed advanced or metastatic solid tumors, including the following: 1. Melanoma 2. Cervical carcinoma 3. Pancreatic carcinoma 4. Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative (TNBC) 5. Hepatocellular carcinoma 6. Urothelial carcinoma 7. Squamous cell carcinoma of the head and neck (HNSCC) 8. Nasopharyngeal carcinoma (NPC) 9. Renal cell carcinoma 10. Colorectal carcinoma or endometrial carcinoma 11. Small cell lung carcinoma or NSCLC 12. Gastric or gastroesophageal junction adenocarcinoma 13. Prostate adenocarcinoma 14. Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer 15. Intrahepatic cholangiocarcinoma * Subjects in the combination cohorts in Part A with XmAb22841 and pembrolizumab may have an advanced solid tumor that either: * has progressed after treatment with all available therapies that are known to confer clinical benefit, or is intolerant or has refused standard treatment (as for the XmAb22841 monotherapy cohorts), or * is of a tumor type for which pembrolizumab is an approved indication and has not previously been treated with an agent targeting PD1 or PDL1. PART B (Dose Expansion Cohorts) XmAb22841 Single Agent Cohort * Must have histologically or cytologically confirmed advanced or metastatic solid tumor that has progressed after treatment with all available therapies that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment. Eligible tumor types include the following: * Anti-PD1 refractory melanoma (or any uveal melanoma) * Anti-PD1 refractory NSCLC * Anti-PD1 refractory renal cell carcinoma (with clear cell component) * Anti-PD1 refractory urothelial carcinoma * Head and neck squamous cell carcinoma * Hepatocellular carcinoma * Gastric adenocarcinoma * Cervical carcinoma * Breast carcinoma that is estrogen receptor, progesterone receptor, and HER2 negative (TNBC) * Epithelial ovarian cancer * Nasopharyngeal carcinoma * Squamous cell anal carcinoma * Squamous cell penile carcinoma * Squamous cell vulvar carcinoma XmAb22841 + Pembrolizumab Cohorts * Anti-PD-1 refractory melanoma (excluding uveal melanoma) * Anti-PD-1 naïve melanoma (excluding uveal melanoma) * Anti-PD-1 refractory NSCLC * Anti-PD1 naïve NSCLC a. Must be PD-L1 high (TPS ≥ 50%), with no EGFR or ALK aberrations * Anti-PD1 naïve urothelial carcinoma 1. Must be PDL1 positive (CPS of ≥ 10), or ineligible for any platinum-containing chemotherapy regardless of PDL1 status; or 2. Had disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy Exclusion Criteria: * Prior treatment with an investigational anti-LAG3 therapy. * Treatment with any CTLA4 antibody within 16 weeks of the start of study drug for Cohorts 1M, 2M, 3M, 1P, and 2P; within 8 weeks for Cohorts 4M, 5M, 3P, 4P and 4Pi; and within 3 weeks for Cohorts 6M, 7Mi, 7M, 5P, and 6P. * Systemic antineoplastic therapy, unconjugated antibody therapy within 4 weeks of the first dose of study treatment; or radiotherapy within 2 weeks of the first dose of study treatment; or small molecule kinase inhibitors within 6 elimination half-lives of the first dose of study treatment. * Have received prior therapy with an anti-PD1, anti-PDL1, or anti PDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA4, OX 40, CD137) AND were permanently discontinued from that treatment due to an irAE. * Failure to recover from any irAE from prior cancer therapy to Grade ≤ 1. * Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to Grade ≤ 2. * Active known or suspected autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus; residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and non-steroidal anti-inflammatory drugs). * Receipt of an organ allograft. * Treatment with antibiotics within 14 days prior to first dose of study drug. * Participants with known HIV. * Participants with known chronic hepatitis B virus (HBV) infection treated for less than 3 months prior to study enrollment and/or with a detectable HBV viral load; or hepatitis C virus (HCV) infection that has been treated for less than 4 weeks prior to study enrollment and/or with a detectable HCV viral load; or active HBV/HCV coinfection.

Study Objectives Prostate cancer is the most common cancer in men. Early detection of primary diseases and recurrence is crucial for patient counseling and management. Conventional imaging modalities (CT-MRI) are limited to detect recurrence. Choline-based PET/CT is currently widely used as primary staging tool in prostate cancer and in patients with suspicious recurrent disease. Compared to choline-based tracers, 68Ga-PSMA ligands have been shown to have a higher diagnostic efficacy and to increase the detection of metastases even at low PSA levels. The most widely used prostate-specific membrane antigen (PSMA) ligand is PSMA-11. A supplier, ANMI, has developed a kit formulation of PSMA-11 which will be test in this clinical trial. Conditions: Prostatic Neoplasm Intervention / Treatment: COMBINATION_PRODUCT: Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit Location: Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * For all individuals * Male gender * Normal renal function (MDRD glomerular filtration rate >60/ml/min/1.73m2) * Normal liver function (bilirubin, alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and gamma glutamyltransferase \[GGT\] <2x upper limit of normal \[ULN\] * Normal bone marrow function (hemoglobin \[Hb\]>12g/dl, white blood cells \[WBC\]>4500/µl, platelets>140,000/µl) * Informed consent For patients with limited recurrent prostate cancer * ≥18 years of age * Radical therapy by surgery or radiotherapy * Prostate specific antigen \[PSA\] level between 0.5 and 2ng/ml confirmed within two weeks before inclusion * Negative or inconclusive findings with standard imaging techniques as assessed by the referring physician with e.g. thoraco-abdominal Computed Tomography \[CT\] scan, bone scan or Magnetic Resonance Imaging \[MRI\] within the previous two months before inclusion * Ability to undergo a one-day experimental study and the appropriate follow-up For healthy volunteers * 18 - 70 years of age * No known prostate disease according to medical history, current symptoms and digital rectal examination * PSA level <3ng/ml * Ability to undergo a two-day experimental study within a time interval of 7-15 days and the appropriate follow-up. Exclusion Criteria: * For all individuals * Urinary incontinence * Chronic renal disease (except nephroangiosclerosis or early diabetic nephropathy) even if renal function is normal * Concomitant malignant disease or diagnosis of cancer within five years prior to enrollment (except basal cell carcinoma) * History of salivary gland disease (except recovered childhood mumps) * History of surgery or radiotherapy of the salivary gland or neck * Medical or psychiatric condition that would preclude the conduct of the study to its end * Pregnant partner

Study Objectives The aim of this study was to define the maximum tolerated dose (MTD) of bolus mitomycin C (MMC) in combination with 24 h-continuous infusion of 5-fluorouracil (FU) plus folinic acid, and to assess the toxicity and activity in patients with previously treated colorectal and gastric cancer. Escalating doses of MMC starting from 6 mg m(-2) in 2 mg m(-2)-steps to a maximum of 10 mg m(-2) were applied on days 1 and 22, given to fixed doses of 5-FU (2.600 mg m(-2)) as 24 h infusion and folinic acid 500 mg m(-2) prior to 5-FU weekly for 6 weeks Conditions: Gastrointestinal Neoplasms, Neoplasm Metastasis Intervention / Treatment: DRUG: Mitomycin C, DRUG: 5-FU, DRUG: Folinic acid Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Phase 1 (dose escalation) * patients with histological proven gastrointestinal neoplasms, without standard therapy option * measurable or evaluable disease * >= second-line therapy (metastasized stage) Phase 2 (efficacy) * patients with proven colorectal neoplasms * measurable disease, metastasized * previous chemotherapy with 5-FU/FA ("AIO-regimen") * age between 18 and 75 years, both male and female * life expectancy > 3 months * WHO-performance status <= 2 * adequate bone marrow function: hemoglobin >= 10 mg/dl, neutrophils >= 2.0 \* 1000000000/l, thrombocytes >= 150 \* 1000000000/l * adequate renal and liver function: bilirubin <= 1.25 \* ULN(<= 1.5 ULN \* by liver metastases), creatinine <= 1.25 \* ULN, ASAT and ALAT <= 3 \* ULN (<= 5\* ULN by liver metastases; AP <= 3\* ULN * written informed consent prior to inclusion into the study Exclusion Criteria: * pretreated with mitomycin c * contraindication concerning 5-FU (e.g. anxiety, myocardial infarction within last 6 months, significant toxicities during previous therapy with 5-FU * florid infections * ileus or subileus, morbus crohn or colitis, ulcerative * actual chronic diarrhea * other uncontrolled severe concurrent disease excluding cytotoxic intervention * second malignancy except basal cell carcinoma or cervical carcinoma in situ * known cns metastases or carcinomatous leptomeningitis * pregnancy or lactation period * no effective contraception * concomitant treatment with another antineoplastic agents * participation in another clinical trial within the last 4 weeks * patients being unwilling or unable to undergo trial specific procedures

Study Objectives This feasibility study will compare two smoking cessation methods, traditional nicotine replacement therapy and Electronic Nicotine Delivery Systems (electronic cigarettes) in patients with gynecological conditions. Conditions: Cervical Dysplasia Intervention / Treatment: OTHER: Nicotine Replacement Therapy, DEVICE: Electronic Cigarettes Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Female * Smokers (defined as those who have smoked at least daily for the last year and who have smoked greater than or equal to 10 or more combustible cigarettes per day during the last year. * Patients with diagnoses of Cervical Dysplasia, Cervical Cancer and Lower Genital Tract Dysplasia and Cancer * Ages 18-65 years Exclusion Criteria: * Patients unwilling to commit to a 6-week intervention that may include either NRT or ENDS. * Patients with previous diagnoses of or treatment for cancer - with the exception of non-melanoma skin cancer. * Presence of any known stroke, heart disease, heart attack, or irregular heart beat. * Pregnancy and lactation. * Plan to continue to use other nicotine in addition to the products supplied by the study. These would include: chewing tobacco, snuff, an additional nicotine patch or other nicotine containing products. * High blood pressure, not well controlled with medication. * Patients using a non-nicotine "smoking cessation medication." * Patients taking a prescription medicine for depression or asthma.

Study Objectives Its to explore the expression pattern, diagnostic and prognostic potentials of miRs (106b-5p, 601 and 760) in serum of NSCLC patients Conditions: Non Small Cell Lung Cancer Intervention / Treatment: OTHER: No intervention Location: Egypt Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * First time and recently diagnosed NSCLC patient Exclusion Criteria: * Recurrent NSCLC * Start of chemotherapy, radiotherapy or surgical intervention * Previous treatment * Cancer history

Study Objectives This is a multicentre randomised controlled trial evaluating global health related quality of life outcomes in patients with malignant pleural effusions. Patients will be randomised to receive either chest drain and talc pleurodesis or indwelling pleural catheter and talc pleurodesis. Patients will be followed up for 3 months post intervention Conditions: Pleural Effusion, Malignant Intervention / Treatment: DEVICE: Chest Drain Insertion and Talc Pleurodesis, DEVICE: Indwelling Pleural Catheter Insertion and Talc Pleurodesis Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Diagnosis of malignant pleural effusion * WHO performance status 2 or less unless performance status is impaired by presence of effusion and likely to significantly improve with drainage * Expected survival greater than 3 months Exclusion Criteria: * Age less than 18 years old * Pregnant or lactating * Known allergy to Talc or Lignocaine * Lack of symptomatic relief from effusion drainage * At least twice weekly drainage cannot be undertaken * Lymphoma or small cell carcinoma except\*: 1. Failure of chemotherapy 2. Deemed for palliative management * Non malignant effusions * Loculated pleural effusion * Unable to provide written informed consent to trial participation

Study Objectives Brain Tumour (BT) survivors struggle with disabling physical, emotional, cognitive and psychosocial sequelae. Unfortunately, to-date there has been very limited research into rehabilitative interventions for this population. With 55,000 BT survivors in Canada alone1, access to effective, evidence-based rehabilitative treatment that would improve BT survivors' quality of life (QOL) and capacity to cope is a necessity. Mindfulness-Based Therapy's (MBTs) are emerging as a potential treatment to address this need. MBTs are group-based psychological treatments for coping with illness or disability, with the goal of improving psychological wellbeing. Recent studies have begun to suggest a role for MBTs in addressing symptom burden and QOL in the acquired brain injury (ABI) population, a heterogeneous population that includes survivors of stroke and traumatic brain injury, as well as BT survivors. High quality research including within-subject controlled trials, are needed to demonstrate whether MBTs can provide efficacious, accessible and cost-effective treatment to improve the lives of BT survivors. Conditions: Brain Tumour, Depressive Symptoms, Survivors Intervention / Treatment: BEHAVIORAL: Mindfulness-based Therapy Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * consenting brain tumour survivor at The Odette Cancer Centre * >six months post-treatment * Ability to communicate, in written and spoken English Exclusion Criteria: * Minimal depressive symptoms (score below 14 on the BDI-II) * Previous head injuries or non-BT neurological diseases * Unaware of deficits (determined through clinical judgement) * Substance abuse / dependence within three months * History of dementia, a recent suicide attempt, or current self-injurious behavior * Previously completed >four weeks of a MBI, or general CBT, in the past three years

Study Objectives The purpose of this study is to investigate whether a training program with intensified physical exercise prior to and after surgery for breast cancer enhances postoperative recovery. Conditions: Breast Cancer Intervention / Treatment: BEHAVIORAL: Physical activity Location: Sweden Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * All female patients at the participating hospital scheduled for breast cancer surgery will be asked to participate. Exclusion Criteria: * Inability to understand given information. * Inability to perform the intervention, as assessed by the person performing inclusion. * Withdrawal of informed consent. * Male sex. * Stage IV breast cancer at diagnosis. * Neoadjuvant breast cancer treatment.

Study Objectives Cancer of the anus occurs at very high rates in young men with HIV and is caused by a virus called human papillomavirus (HPV). Anal cancer has increased during the HIV epidemic despite effective therapies for HIV. Unfortunately, anal cancer presents at a late stage because there is no screening program to find it at an early stage. Rates of other cancers such as cervical cancer have been reduced through the use of Pap smears. The researchers' plan is to do the same type of screening for anal cancer as has been done for cervical cancer. If abnormalities are found then treatment can be started. The researchers hope that this approach will help to prevent anal cancer. Testing for HPV will also be done to see if this helps to detect early cancer and to see how accurate different tests, pathologists and clinical examiners are at detecting and agreeing on any abnormalities. The main outcome is the presence of any pre-cancerous or early cancer changes as determined by high resolution anoscopy (HRA). HRA involves looking through a microscope into the anus and this allows very tiny changes to be identified. Pieces of tissue can then be taken to make a definite diagnosis. Conditions: HIV Infections, Anal Cancer, Anal Dysplasia, Papillomavirus Infections Location: Canada Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * HIV-infected men, * History of anal receptive intercourse, * Minimum age 18 years. Exclusion Criteria: * Known anal cancer, * Bleeding diathesis that might preclude anoscopy and biopsy.

Study Objectives The purpose of this study is to determine whether UTD1 Injection in combination with capecitabine is effective in the treatment of advanced metastatic breast cancer using capecitabine as a control. Conditions: Breast Cancer Intervention / Treatment: DRUG: UTD1 Injection plus capecitabine, DRUG: Capecitabine Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically and/or cytologically diagnosed patients with advanced, metastatic breast cancer,or lacking standard therapy or being failed to or recurrent after standard therapy; * Patients who have previously treated with ≤4 chemotherapeutic regimes; * Patients who have previously treated with an anthracyclin antibiotics and a taxane; * Age 18 -70 years old, ECOG performance status of 0-2; Life expectancy of 3 months or more; * Patients with at least 1 measurable target lesion determined by CT within 2 weeks prior to enrollment; * Neuropathy <CTC2 degree （NCI CTC4.03）within 4 weeks prior to enrollment; * Basically normal results from routine blood test within 1 week prior to enrollment; * Basically normal liver and renal functions within 1 week prior to enrollment; * No abnormal function for major internal organs, no heart diseases. Exclusion Criteria: * Received chemotherapy, radiotherapy, therapies with hormones or molecularly targeted drugs 4 weeks prior to enrollment, or received other chemotherapies while participating in this trial; * Patients with documented hypersensitivity to Cremophor EL, or patients with previous taxane treatment related SAE; * Patients of pregnancy or breast feeding; * Patients with previous standard capecitabine treatment ineffective, or patients received standard capecitabine treatment effective, but with less than 6 months of capecitabine clearance period; * Patients with uncontrolled brain metastasis or bone metastasis, which plan for recent surgery or local radiotherapy, or other emergency treatment; * Patients combined with severe and /or uncontrolled medical conditions, including severe cardiovascular disease, uncontrolled diabetes and high blood pressure, severe infection, severe gastrointestinal ulceration, and patients with incontrollable psychiatric history; * Patients with poor compliance; * Patients not fitted for this study determined by the investigators.

Study Objectives The goal of this study is to develop additional long term data to evaluate the safety and effectiveness of this treatment. Indications for use for this system is: 'The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not seeking treatment for reasons of improving fertility.' Conditions: Leiomyoma Intervention / Treatment: DEVICE: ExAblate 2000 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Women who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility. * Able and willing to give consent and able to attend all study visits. * Patient is pre or peri-menopausal (within 12 months of last menstrual period). * Able to communicate sensations during the ExAblate procedure. * Uterine fibroids, which are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone). * Fibroids(s) clearly visible on non-contrast magnetic resonance imaging (MRI). Exclusion Criteria: * Metallic implants that are incompatible with MRI * Sensitive to MRI contrast agents * Severe claustrophobia that would prevent completion of procedure in MR unit * Women who are pregnant or desire to become pregnant in the future. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus. * Pedunculated fibroids * Active pelvic inflammatory disease (PID) * Active local or systemic infection * Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia * Intrauterine device (IUD) anywhere in the treatment path * Dermoid cyst of the ovary anywhere in the treatment path * Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g., due to Caesarean section or repeated abdominal surgeries) * Undiagnosed vaginal bleeding

Study Objectives In this study, investigators utilize a radiopathomics integrated Artificial Intelligence (AI) supportive system to predict tumor response to neoadjuvant chemoradiotherapy (nCRT) before its administration for patients with locally advanced rectal cancer (LARC). By the system, whether the participants achieve the pathologic complete response (pCR) will be identified based on the radiopathomics features extracted from the pre-nCRT Magnetic Resonance Imaging (MRI) and biopsy images. The predictive power to discriminate the pCR individuals from non-pCR patients, will be validated in this multicenter, prospective clinical study. Conditions: Rectal Cancer Location: China Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * pathologically diagnosed as rectal adenocarcinoma * defined as clinical II-III staging (≥T3, and/or positive nodal status) without distant metastasis by enhanced Magnetic Resonance Imaging (MRI) * intending to receive or undergoing neoadjuvant concurrent chemoradiotherapy (5-fluorouracil based chemotherapy, given orally or intravenously; Intensity-Modulated Radiotherapy or Volume-Modulated Radiotherapy delivered at 50 gray (Gy) in gross tumor volume (GTV) and 45 Gy in clinical target volume (CTV) by 25 fractions) * intending to receive total mesorectum excision (TME) surgery after neoadjuvant therapy (not completed at the enrollment), and adjuvant chemotherapy * MRI (high-solution T2-weighted imaging, contrast-enhanced T1-weighted imaging, and diffusion-weighted imaging are required) examination is completed before the neoadjuvant chemoradiotherapy * biopsy H\&E stained slides are available and scanned with high resolution before the neoadjuvant chemoradiotherapy Exclusion Criteria: * with history of other cancer * insufficient imaging quality of MRI to delineate tumor volume or obtain measurements (e.g., lack of sequence, motion artifacts) * insufficient imaging quality of biopsy slides imaging to delineate tumor volume or obtain measurements (e.g., tissue dissection, color anomaly) * incomplete neoadjuvant chemoradiotherapy * no surgery after neoadjuvant chemoradiotherapy resulting in lack of pathologic assessment of tumor response * tumor recurrence or distant metastasis during neoadjuvant chemoradiotherapy

Study Objectives This study will examine the effectiveness and side effects of an experimental vaccine to prevent recurrence of nasopharyngeal cancer. The likelihood of this cancer returning is higher in patients whose original lesion was large, whose cancer had spread to the adjacent lymph nodes, or who had surgery for metastatic disease (cancer that spread beyond the primary site). Nasopharyngeal tumors are caused by a common virus called Epstein-Barr virus, which produces a protein called LMP-2. Vaccination with specific pieces, or peptides, of the LMP-2 protein may boost the immune system's fight against the cancer. The vaccine injections are mixed with an oil-based substance called Montanide ISA-51, which is intended to increase the immune response to the peptide. Patients 18 years of age and older whose nasopharyngeal cancer has been controlled by standard treatment with surgery, chemotherapy, or radiation therapy and who are currently free of disease may be eligible for this study. Candidates are screened with a physical examination and blood and urine tests. x-rays and other imaging studies are also done in patients who have not had these tests recently. All candidates are tested for HLA tissue type. Only patients with type HLA-A\*1101 or HLA-A\*2402 - the types on which the two vaccines in this study are based - receive vaccine therapy; others are offered standard medical treatment and observation. Participants are randomly assigned to receive injections of one of two different vaccines (LMP-2:340-349 or LMP-2:419-427) to determine which peptide may offer the best immunity. Each treatment course consists of weekly immunizations for 8 consecutive weeks. The injections are given under the skin of the thigh. After every other treatment course (about every 3 months), patients undergo a series of x-rays and scans to look for tumor. The immunizations are given at the NIH Clinical Center. Patients are monitored for 1 hour after each injection and have blood tests and a physical examination to look for treatment side effects. Immunizations may continue for up to 12 months as long as the cancer does not return. Patients are followed with blood tests every 12 weeks to monitor body functions. They also undergo leukapheresis-a procedure to collect white blood cells-before starting treatment and about 3 to 4 weeks after the fourth vaccine to evaluate how the vaccines affect the action of the immune system cells. For this procedure, blood is drawn through a needle in the arm, similar to donating blood. The blood is processed by a machine that separates and removes the lymphocytes (white blood cells), and the rest of the blood is returned through a needle in the other arm. Patients not receiving the vaccine also undergo leukapheresis to assess their natural response to LMP-2. Some patients may have a biopsy-surgical removal of a small piece of tissue under local anesthetic-of normal skin and tumor or lymph node tissue to examine the vaccine's effects on the tumor immune cells. Patients who show no evidence of immunization against the LMP-2 protein after two courses of vaccine treatment are subsequently be followed with observation alone. Those who do respond to the vaccine are offered two additional courses of treatment to strengthen the response or to be followed by observation alone. Patients whose disease recurs after completing the first two treatment courses are taken off the study and referred back to their local physician or to another study, if an appropriate one is available. Conditions: Nasopharyngeal Neoplasms Intervention / Treatment: DRUG: EBV-LMP-2 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT

INCLUSION CRITERIA: * HLA-A\*1101 and HLA-A\*2402 patients, greater than 18 years of age, with advanced local disease (T3-T4N0-1M0), nodal disease (T1-T2N2-3M0) and loco-regional disease (T3-T4N2-3M0) at onset but presently controlled by standard therapy (combination of chemotherapy and radiotherapy) or with completely resected metastatic disease, 3 months after the completion of their primary treatment will be considered. All subjects will be judged disease free based on physical examination, ENT endoscopy, CT scan of abdomen, chest, neck and nasal sinuses and MRI of the head. All subjects must have received standard surgical, chemotherapy and radiation therapy appropriate for their stage of disease. Currently, standard treatment for locally advanced NPC in the U.S. consists of concomitant cisplatin with radiation followed by 3 courses of cisplatin and 5-fluorouracil. This, or comparable standard therapies will be considered part of standard therapy and patients will be considered for accrual three or more months after its completion. Patients must demonstrate evidence of local control with no histological or radiological evidence of recurrent disease three months after the end of standard therapy and be, otherwise, clinically disease free at the time of protocol entry as documented by radiological studies within 6 weeks of patient entry. Physical and histological evidence of disease recurrence at the time of patients' screening and during follow up will be performed under the supervision of Dr. Carter Van Waes during an out patient evaluation. Similar enrollment criteria will be used with patients who do not bear HLA-A\*1101 or HLA-A\*2402. However, these patients will be followed by observation only. * Pathologic confirmation of nasopharyngeal carcinoma by the NCI Laboratory of Pathology (NPC). * serum creatinine of 2.0 mg/dl or less, * Total bilirubin 1.6 mg/dl or less, except for patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl. * WBC 3000/mm(3) or greater, * platelet count 90,000 mm(3) or greater, * serum AST/ALT less than three times normal, * ECOG performance status of 0 or 1. * Patients of both genders must be willing to practice effective birth control during this trial because the potential for teratogenic effects are unknown. * Patients may have had prior adjuvant treatment or may have had treatment for metastatic disease and are now with no evidence of disease, including chemotherapy or biotherapy, as long as 1 month has elapsed since prior systemic therapy. EXCLUSION CRITERIA: Patients will be excluded: * Who are undergoing or have undergone in the past 3 weeks any systemic therapy except surgery for their cancer, and must have recovered from any adverse effects of treatment prior to entry, other than those that do not have clinical implications, e.g. alopecia. In the case a patient has received surgical intervention; at least one month should pass before enrollment in the study. All toxicity from previous therapy must have resolved to less than or equal to Grade 1 by NCI-CTC v 3.0 before enrollment. * Who have active systemic infections, autoimmune disease or any known immunodeficiency disease. d. Who require systemic steroid therapy. e. Who are pregnant (because of possible side effects on the fetus) or breastfeeding (because of unknown effects on the developing child). f. Who are known to be positive for hepatitis BsAG or HIV antibody (because of possible immune effects of these conditions). Patients who may screen or have history positive for hepatitis C may be enrolled if their transaminases levels are within the limits specified in inclusion criteria. g. Who have any form of active primary or secondary immunodeficiency or who have not recovered immune competence after chemotherapy or radiation therapy. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.) Active or secondary immunodeficiency will be judged based on the patient past medical history and normality of circulating T and B cell counts (Normal range 650-2, 108 and 49 to 424 respectively, Department of Laboratory Medicine, CC). In the similar fashion recovery from chemotherapy and radiation therapy will be evaluated. Previous experience in patients with melanoma or renal cell carcinoma who underwent chemotherapy of local radiation demonstrated that they immune response to common T cell epitopes such as Flu or Cytomegalovirus are rapidly restored within the first month from such treatment (unpublished observation). h. Who have known hypersensitivity to any of the agents used in this study.

Study Objectives Although health-related interventions should become increasingly diversity-sensitive, there will always be a need of adapting specific interventions to some immigrant populations. Adapting selected services to the individual cultural and religious background is necessary to reduce health inequalities and provide effective health care and is dependent on the active involvement of users. In this proposal the investigators present a community-based health intervention trial with two parallel interventions aimed at increasing participation of immigrant women to the existing cervical cancer-screening program. Through this study, the investigators will provide new practice-based knowledge and a firmer evidence base to improve health interventions that can contribute to equal health care and good health for all - including the immigrant population. Based on identified barriers and factors that influence the interactions between immigrants and health care professionals for screening of cervical cancer in Norway, the investigators have develop two adapted interventions. One strategy will target immigrant women, and the other one will focus on general practitioners. Thus, this proposal will specifically contribute to the development of personalized health prevention interventions for the most common cancer-screening program in Norway, with a focus on immigrant's personal circumstances and health care needs. Conditions: Cervical Cancer Intervention / Treatment: BEHAVIORAL: User intervention, BEHAVIORAL: Health professional intervention Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Inclusion Criteria: * For the women: Women from Somalia and Pakistan living in the intervention areas * For the health professionals: GPs working in the intervention areas * Exclusion Criteria: None

Study Objectives To investigate bevacizumab in combination with carboplatin and capecitabine for patients with unresectable or metastatic GEJ or gastric cancers. We hope that by adding bevacizumab to standard chemotherapy for this patient population we will improve Progression Free Survival by 90% over historical controls. Conditions: Stomach Cancer, Gastric (Stomach) Cancer, Neoplasm of Cardioesophageal Junction, Gastrointestinal Stromal Tumor (GIST) Intervention / Treatment: DRUG: bevacizumab, DRUG: carboplatin, DRUG: capecitabine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Subjects must be treated at Stanford University Medical Center for the entire length of study participation. * Patients with histologically or cytologically confirmed adenocarcinoma of the GEJ or stomach. * Patients must be deemed unresectable due to involvement of critical vasculature or adjacent organ invasion. If unresectable, patients must show evidence of disease progression prior to enrollment. * Patients with prior surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless an interval of > 5 years has elapsed between the primary surgery and the development of metastatic disease. Clinicians should consider biopsy of lesions to establish diagnosis of metastatic disease if there is substantial clinical ambiguity regarding the nature or source of apparent metastases. * Prior carboplatin as neoadjuvant or adjuvant therapy will be allowed if >= 6 months from the time of study entry. * If patients use aspirin (>325mg/day) or NSAIDS at the time of enrollment, they must have a 10 day washout period prior to beginning protocol treatment. * Low molecular weight heparin (or its equivalent, excluding warfarin) will be allowed for treatment of venous thromboembolic events if patients have no evidence of bleeding on full-dose anticoagulation. * Patients must have a primary or metastatic lesion measurable in at least one dimension by Modified RECIST criteria (see Section 11.2.3) within 4 weeks prior to entry of study * Patients must have ECOG performance status of 0-1 * Patients must be >= 18 years of age * Laboratory values <= 2 weeks prior to randomization: * Absolute Neutrophil Count (ANC) >= 1.5 x 109/L (>= 1500/mm3) * Platelets (PLT) >= 100 x 109/L (>= 100,000/mm3) * Hemoglobin (Hgb) >= 9 g/dL * Serum creatinine <= 1.5 x ULN * Serum bilirubin <= 1.5 x ULN (<= 3.0 x ULN if liver metastases present) * Aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT) <= 3.0 x ULN (<= 5.0 x ULN if liver metastases present). Note: ERCP or percutaneous stenting may be used to normalize the liver function tests. * Life expectancy >= 12 weeks * Inclusion and exclusion criteria for DCE-MRI and DWI imaging will be determined by CT scan as part of routine post-chemotherapy imaging. Subjects will be eligible if one liver metastasis is greater than 1 cm in size. Participation in the DCE-MRI and DWI correlate is not required for eligibility. * Ability to give written informed consent according to local guidelines Exclusion Criteria: * Disease-Specific Exclusions 1. Prior chemotherapy for metastatic disease 2. Prior full field radiotherapy <= 4 weeks or limited field radiotherapy <= 2 weeks prior to enrollment. Patients must have recovered from all therapy-related toxicities. The site of previous radiotherapy should have evidence of progressive disease if this is the only site of disease. 3. Prior biologic or immunotherapy <= 2 weeks prior to registration. Patients must have recovered from all therapy-related toxicities 4. Prior therapy with anti-VEGF agents 5. If history of other primary cancer, subject eligible only if she or he has: * Curatively resected non-melanomatous skin cancer * Curatively treated cervical carcinoma in situ * Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 3 years 6. Concurrent use of other investigational agents and patients who have received investigational drugs <= 4 weeks prior to enrollment. 7. Hypersensitivity to capecitabine, fluorouracil, or any component of the formulation and or a known deficiency of dihydropyrimidine dehydrogenase. * General Medical Exclusions 1. Subjects known to have chronic or active hepatitis B or C infection 2. History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study results 3. Male subject who is not willing to use adequate contraception upon enrollment into this study and for 6 months following the last dose of second-line treatment 4. Female subject (of childbearing potential, post-menopausal for less than 6 months, not surgically sterilized, or not abstinent) who is not willing to use an oral, patch or implanted contraceptive, double-barrier birth control, or an IUD during the course of the study and for 6 months following the last dose of second-line treatment 5. Female subject who is breast-feeding or who has positive serum pregnancy test 72 hours prior to randomization 6. Pleural effusion or ascites that causes respiratory compromise (>= CTCAE grade 2 dyspnea) 7. Any of the following concurrent severe and/or uncontrolled medical conditions within 24 weeks of enrollment which could compromise participation in the study: * Unstable angina pectoris * Symptomatic congestive heart failure * Myocardial infarction <= 6 months prior to registration and/or randomization * Serious uncontrolled cardiac arrhythmia * Uncontrolled diabetes * Active or uncontrolled infection * Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung. * Chronic renal disease * Acute or chronic liver disease (e.g., hepatitis, cirrhosis) 8. Patients unwilling to or unable to comply with the protocol 9. Life expectancy of less than 12 weeks 10. Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study * Bevacizumab-Specific Exclusions 1. Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications) 2. Any prior history of hypertensive crisis or hypertensive encephalopathy 3. New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix A) 4. History of myocardial infarction or unstable angina within 6 months prior to study enrollment 5. History of stroke or transient ischemic attack within 6 months prior to study enrollment 6. Known CNS disease, brain metastases. 7. Significant vascular disease (e.g., aortic aneurysm, aortic dissection) 8. Symptomatic peripheral vascular disease 9. Evidence of bleeding diathesis or coagulopathy 10. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study 11. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment 12. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment 13. Serious, non-healing wound, ulcer, or bone fracture 14. Urine protein >= 2+ on urinalysis dipstick and >= 1.0 gram on 24-hour urine collection 15. Known hypersensitivity to any component of bevacizumab 16. History of hemoptysis (bright red blood of ½ teaspoon or more per episode) within 3 months prior to study enrollment. 17. Current, ongoing treatment with full-dose warfarin.

Study Objectives All patients undergoing breast cancer surgery are left with scars which can significantly affect their physical and psychological well being. Patients with breast cancer, motivated to optimize healing and function, have inquired about the advisability of scar massage after surgery. Although this is a popular technique advocated by physiotherapists and massage therapists to improve pain, range of motion, and scar pliability, there is currently no scientific research to prove the benefits and/or risks of scar massage in breast cancer patients. We propose to study the effect of scar massage on pain, arm function, scar formation, and quality of life in patients with breast cancer. Patients who have had breast cancer surgery and who have been referred to the BC Cancer Agency, Vancouver Island Centre will be offered participation in this research study. To objectively evaluate the effects of scar massage, those who agree to participate will be randomly assigned to one of two groups. One group will be taught to perform self-massage of the scars as soon as the scars have adequately healed. The massage should be done about 10 minutes each day for a total of 6 months. The other group will not be taught self-massage and will be asked to not massage their breast scars. In both groups, we will monitor pain, upper body range of motion, scar characteristics and quality of life using standardized criteria for 2 years from the time of surgery. Problems with infections or blood or fluid accumulation at the scar areas will also be monitored. After 2 years, the information collected will be analyzed and compared to see if there are differences in pain, function or quality of life between the two groups. The results from this study will provide scientific proof of whether or not scar massage after surgery is beneficial for patients with breast cancer. Conditions: Breast Cancer Intervention / Treatment: PROCEDURE: Scar massage. Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients must be able to provide informed consent and be physically able to perform daily self-administered breast scar massage * Female or male patients with histologically-confirmed invasive or in situ breast cancer * Definitive surgery with BCS or mastectomy +/- axillary dissection or sentinel node sampling * Adequate surgical healing as judged by treating oncologist during pre-enrolment assessment * Age 18 years or older with ability to provide written informed consent. * Ability to start massage within 8 weeks from surgery and comply with daily regimen if randomized to the intervention cohort * Ability to comply with not performing massage if randomized to the control cohort

Study Objectives The primary objective of this study is to evaluate the safety and feasibility of Magnetic Resonance Image (MRI) guided focal prostate cancer laser thermal ablation in males, ages 40-80 with biopsy confirmed early clinical stage prostate cancer (T1c or T2a) with an identifiable lesion on mutliparametric MRI, with a Prostate Specific Antigen (PSA) of \< 15ng/ml, who have not yet undergone pelvic radiation or hormonal deprivation therapy. Conditions: Prostate Cancer Intervention / Treatment: PROCEDURE: MRI Targeted Focal Laser Thermal Therapy Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Men 45-80 years of age; * Histologically proven prostate carcinoma; * Prostate cancer clinical stage T1c and T2a * Prostate MRI must confirm area suspicious for cancer in the sector of the positive biopsy; * Prostate specific antigen (PSA) level less than 15 ng/mL * 12 cores biopsy, with histologically proven prostate carcinoma, in the suspicious region on MRI. * IPSS and IIEF complete prior to procedure * Life expectancy of greater than 5 years, based on co-morbidity not related to prostate cancer. Exclusion Criteria: * Medically unfit for focal therapy of the prostate * Patients who are unwilling or unable to give informed consent; * Patients who have received androgen suppression therapy * Patients who have received or are receiving chemotherapy for prostate carcinoma; * Patients previously treated with surgery to the prostate (traditional, endoscopic or minimally invasive including HIFU, TUNA, RITA, microwave, TURP, cryotherapy or any curative treatment * Patients who have undergone radiation therapy for prostate cancer or to the pelvis * Any condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies); * Patients with a history of non compliance with medical therapy and/or medical recommendations; * Patients who are unwilling or unable to complete the patient self-assessment questionnaires; * Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter abnormalities, or any other symptom that prevents normal micturition. * Patients who have participated in a clinical study and/or received treatment with an investigational treatment and/or product within the past 90 days; * If the patient is unable to undergo regional anesthesia * Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent) * Any condition, or history of illness that, in the opinion of the investigator will confound or increase the patient risk during the study

Study Objectives Endoscopic characterization of colorectal lesions has become essential to predict histology and choose the best therapeutic strategy. We have created the CONECCT classification grouping all the endoscopic criteria already published in a single table. To validate this classification, we carried out this comparative study evaluating the endoscopic characterization performance of all recognized classifications and CONECCT in terms of inter-observer agreement and histological prediction. Conditions: ENDOSCOPIC CHARACTERIZATION Intervention / Treatment: PROCEDURE: DIGESTIVE ENDOSCOPY Location: France Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * none Exclusion Criteria: * none

Study Objectives Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with rituximab may kill more cancer cells. This phase II trial is studying how well giving bortezomib together with rituximab works as first-line therapy in treating patients with low-grade B-cell non-Hodgkin's lymphoma. Conditions: Non-Hodgkin's Lymphoma Intervention / Treatment: DRUG: Rituximab, DRUG: bortezomib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed low-grade B-lymphocyte non-Hodgkins lymphoma * Life expectancy > 12 months Exclusion Criteria: * No known history of HIV infection * No other active infection * No peripheral neuropathy ≥ grade 2 within the past 14 days * No uncontrolled hypertension * None of the following cardiac conditions: * Myocardial infarction within the past 6 months * No heart failure * Uncontrolled angina * Severe uncontrolled ventricular arrhythmias * Electrocardiographic evidence of acute ischemia * Active conduction system abnormalities * No serious medical or psychiatric illness that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior therapy for non-Hodgkins lymphoma * No prior bortezomib or rituximab * At least 3 weeks since prior chemotherapy, radiation therapy, immunotherapy, systemic anticancer biologic therapy, or anticancer hormonal therapy * At least 2 weeks since prior investigational drugs * No other concurrent systemic cytotoxic chemotherapy or investigational agents + No leukemia

Study Objectives Background: Stem cell transplantation (SCT) is associated with pulmonary complications and may lead to high morbidity and mortality. We encountered several children post-SCT with a clinical picture suggestive of airway hyper-reactivity (AHR) and evidence of reversible airway obstruction that was not reported pre-transplant. Our aim was to determine if SCT induced AHR as assessed by methacholine challenge test (MCT) and to determine any correlation between AHR and pulmonary complications. Methods: Prospective study evaluating consecutive patients referred for SCT to the Department of Pediatric Hemato-Oncology at Meyer Children's Hospital. Evaluation included pulmonary function test and methacholine challenge test before and after the transplantation, and assessment of pulmonary complications. Conditions: Cancer Location: Israel Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * age 4.5-20 years * ability to perform spirometry consistently * FEV1>70% predicted Exclusion Criteria: * FEV1<70% * inability to perform methacholine challenge test before and after stem cell transplantation.

Study Objectives RATIONALE: Biological therapies, such as denileukin difitox, may stimulate the immune system in different ways and may prevent tumor cells from growing. PURPOSE: This phase I trial is studying the side effects and best dose of denileukin diftitox in treating patients with advanced refractory ovarian cancer, primary peritoneal carcinoma, or epithelial fallopian tube cancer. Conditions: Fallopian Tube Cancer, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mixed Epithelial Carcinoma, Ovarian Mucinous Cystadenocarcinoma, Ovarian Serous Cystadenocarcinoma, Ovarian Undifferentiated Adenocarcinoma, Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer Intervention / Treatment: BIOLOGICAL: denileukin diftitox, PROCEDURE: intraperitoneal administration, OTHER: laboratory biomarker analysis, OTHER: enzyme-linked immunosorbent assay, OTHER: flow cytometry Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with a histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or epithelial fallopian tube carcinoma * Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, transitional cell carcinoma, and mixed epithelial carcinoma * Patients with advanced stage refractory ovarian carcinoma: patients unable to achieve first complete remission (CR) with first or second line chemotherapy OR patients with disease relapse after achieving second CR * Patients must be 30 days out from last chemotherapy; previous chemotherapy must include a platinumbased regimen and paclitaxel (Taxol) * Patients must have undergone primary debulking surgery * Patients must have a peritoneal catheter suitable for I.P. infusion * White blood cell count (WBC) > 3.0 THOU/ul * Serum creatinine =< 2.5 mg/dL * ALT =< 2.5 x upper limit of normal * AST =< 2.5 x upper limit of normal * Total bilirubin =< 2.0 x upper limit of normal * Albumin >= 3.0 g/dL * Subjects must have a Performance Status Score (Zubrod/SWOG Scale) =< 2 * Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment * Lymphocytes > 1.0 THOU/ul * Platelets >= 100 THOU/ul Exclusion Criteria: * Prior treatment with ONTAK (DAB389IL-2) or DAB486IL-2 * Known history of hypersensitivity to diphtheria toxin or IL-2 * Moderate (symptomatic requiring the use of diuretics) or severe (symptomatic requiring paracentesis or other invasive intervention) ascites * Active autoimmune disease * Known history of pulmonary disease except controlled asthma * Known history significant cardiac disease * Concurrent malignancy requiring active treatment * Clinical or radiological evidence of acute bowel obstruction within 30 days of enrollment

Study Objectives In this study Drug-eluting microbeads (DEB) loaded with Doxorubicin will be delivered into the target Desmoid Fibromatoses (DF) tissue via selective arterial embolization by angiographic technique. The objective of the study is to demonstrate the safety and efficacy of this treatment. Conditions: Desmoid, Desmoid Fibromatosis of Skin, Desmoid Neoplasm of Chest Wall, Desmoid Tumor Caused by Somatic Mutation, Aggressive Fibromatoses, Fibromatosis Desmoid, Desmoid Fibromatosis Intervention / Treatment: PROCEDURE: Drug Eluting Bead Embolization (DEB) for Desmoid Fibromatosis Location: Israel Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age 3-80 years. * Histologically confirmed diagnosis of Desmoids Fibromatosis. * After at least one systemic treatment line. Standard first line systemic treatment may include: Methotrexate, Vinblastine, Doxorubicin, Liposomal Doxorubicin (Doxil), NSAIDS or hormonal treatment. If first line treatment is renounced, this treatment decision must be documented. Considering the trend of avoiding surgical treatment, the documentation must include that the treatment decision is not associated to the resectability of the tumor. * Karnofsky performance status (PS)>50% for patients older than 16 years or Lansky PS >50% for patients under 16 years. * At least one measurable lesion, with a long diameter of at least 30mm, with an anatomical location accessible for endovascular treatment. * T2 signal increase on MRI. * No evidence of prior treatment toxicity, adequate washout period after prior treatment: * 14 days after myelosuppressive chemotherapy treatment. * 7 days after GCSF (Granulocyte colony-stimulating factor), 14 days after Neulastim. * 7 days after targeted/biologic treatment. * Female patients of childbearing potential must be willing to use an adequate method of contraception (hormonal, barrier or abstinence) for the treatment period and up to 90 days after the treatment completion. * Willing and able to provide written informed consent for the trial. Exclusion Criteria: * Participation in another interventional study. * Congestive heart failure, characterised by LVEF (Left Ventricular Ejection Fraction) < 50% or Shortening fracture < 27%. * Previous treatment with anthracycline of a accumulative dose of more than 360 mg/m2. * History of allergic reaction attributed to Doxil or doxorubicin treatment. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements.

Study Objectives This is an open-label Phase 1a dose escalation study of single-agent OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies. Study includes a dose escalation phase and expansion phase. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. Conditions: Relapsed or Refractory Lymphoid Malignancies Intervention / Treatment: DRUG: OMP-52M51 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Lymphoid malignancy that has relapsed or is refractory after two or more treatments that are FDA approved or are commonly used clinically. * Subjects must have progressive disease requiring therapy. Subjects who are candidates for observation only are not eligible. * Subjects are either not currently considered to be candidates or refuse potentially curative therapies including peripheral stem cell or bone marrow transplant * Subjects must have measurable disease as per disease specific criteria * Must have received their last chemotherapy, biologic, radiotherapy, or investigational therapy at least 4 weeks prior to enrollment; 12 weeks from their last radioimmunotherapy; 3 months if the last therapy was bone marrow/ peripheral stem cell transplant. * Age >18 years * ECOG performance status <2 * Normal Ejection Fraction on ECHO scan * Subjects must have normal organ and marrow function as defined below: Absolute neutrophil count >1000/mL Platelets >75,000/mL For subjects with known marrow infiltration, ANC ≥500 and platelets ≥30,000 Total bilirubin <1.5 X institutional upper limit of normal (ULN) (<2X ULN for subjects with Gilbert's syndrome) AST (SGOT) and ALT (SGPT) <3 X institutional ULN (for subjects with hepatic involvement <5 X institutional ULN) PT/INR and aPTT within 1.5 X institutional ULN Creatinine <1.5 X institutional ULN OR Creatinine clearance >60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal * Women of childbearing potential must have had a prior hysterectomy or have a negative serum pregnancy test and be using adequate contraception prior to study entry and must agree to use adequate contraception from study entry through at least 6 months after discontinuation of study drug. Men must also agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and from study entry through at least 6 months after discontinuation of study drug. Should a woman enrolled in the study or a female partner of a man enrolled in the study become pregnant or suspect she is pregnant while participating in this study or within 6 months after discontinuation of study, she should inform the Investigator immediately. * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Subjects who meet any of the following criteria will not be eligible for participation in the study: * Currently receiving any therapeutic treatment for lymphoid malignancies including other investigational agents * Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors * Active CNS involvement, uncontrolled seizure disorder, or active neurologic disease * History of a Grade 4 allergic reaction attributed to humanized or human monoclonal antibody therapy * Significant intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women or nursing women * Ongoing malignancies or malignancies in remission <3 years other than the lymphoid malignancies included in this trial. Patients with history of known skin cancers including non-melanotic skin cancers within the past 3 years will not be included in this trial. The following prior malignancies are allowable irrespective of when they occurred: in situ carcinoma of the cervix, in situ ductal breast cancer, and low-grade local bladder cancer. * Subjects with known HIV infection * Known bleeding disorder or coagulopathy * Subjects receiving heparin, warfarin, or other similar anticoagulants, except for subjects on low molecular weight heparin for DVT/PE prophylaxis. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents. * New York Heart Association Classification II, III, or IV * Subjects with a blood pressure of >140/90 mmHg that is not responsive to medical therapy. Subjects taking antihypertensive medications must be taking ≤2 medications to obtain this level of blood pressure control. * Subjects with EKG evidence of ischemia or ≥Grade 2 ventricular arrhythmia, subjects who have a history of acute myocardial infarction within 6 months, or subjects with unstable angina. * Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease * Subjects with diarrhea at time of enrollment or have an ongoing requirement for anti diarrheal therapy

Study Objectives This pilot early phase I trial studies the side effects of temozolomide, radiation therapy, and tumor treating fields therapy using Novo tumor treatment fields (TTF)-200A device in participants with glioblastoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. NovoTTF-200A device is a portable device that produces alternating electrical fields that may disrupt growth of cancer cells. Giving temozolomide, radiation therapy, and tumor treating fields therapy using NovoTTF-200A device may work better in treating participants with glioblastoma. Conditions: Glioblastoma Intervention / Treatment: DRUG: Temozolomide, RADIATION: Radiation Therapy, DEVICE: NovoTTF-200A Device, PROCEDURE: Tumor Treating Fields Therapy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with pathology confirmed newly diagnosed World Health Organization (WHO) grade IV glioma * Karnofsky performance status (KPS) ≥ 60 * Patients must have recovered from the effects of surgery per treating physician's judgment; there must be a minimum of 21 days from the day of surgery to the day of protocol treatment; for core or needle biopsy, a minimum of 14 days must have elapsed prior to the day of protocol treatment * Absolute neutrophil count (ANC) ≥ 1,000 cells/mm\^3 * Platelets ≥ 100,000 cells/mm\^3 * Hemoglobin ≥ 9.0 g/dl * Creatinine clearance > 30 mL/min * Bilirubin < 2.0 mg/dL * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 3 x upper limit of normal range * Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 14 days prior to registration * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 4 months after last dose of temozolomide * Is able to have magnetic resonance imaging (MRI) with contrast of the brain * All subjects must be able to comprehend and sign a written informed consent document. If the subject can comprehend the informed consent but is unable to sign, a LAR may sign the written informed consent document. Exclusion Criteria: * Infratentorial disease (defined as glioblastoma \[GBM\] derived from cerebellum or brainstem) * Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias * A skull defect (such as, missing bone with no replacement) * Women of childbearing potential who are pregnant or breastfeeding * Evidence of increased intracranial pressure (midline shift > 5 mm, clinically significant papilledema) * Serious medical or psychiatric illness likely to interfere with participation in this clinical study, in the opinion of the investigator * Prior radiation treatment to the brain * Prior treatment with temozolomide * Known hypersensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes * Known active collagen vascular disease

Study Objectives This single arm study will evaluate the benefit of adding MabThera to standard induction chemotherapy in patients with newly diagnosed mantle cell lymphoma. The safety and tolerability of a MabThera-containing first line regimen will also be assessed. All patients will receive MabThera (375mg/m2 iv) every 3 weeks for 8 cycles, in combination with standard chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals. Conditions: Mantle Cell Lymphoma Intervention / Treatment: DRUG: rituximab [MabThera/Rituxan], DRUG: First line chemotherapy Location: Hungary Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * histologically-proven mantle cell lymphoma; * previously untreated disease at stage II, III and IV, requiring therapy. Exclusion Criteria: * known hypersensitivity reaction to rituximab, or known anti-murine antibody reactivity or known hypersensitivity to murine antibodies; * active malignancy other than mantle cell lymphoma within 5 years of start of study, with the exception of resected basal cell cancer, squamous cell cancer of the skin, or in situ cancer of the cervix; * serious disorders interfering with full standard dosing chemotherapy; * stage I disease.

Study Objectives Serrated polyposis syndrome (SPS) is the most common colorectal polyposis syndrome and is characterized by the combination of large and/or numerous serrated lesions (SLs) throughout the colorectum. SLs are classified into sessile serrated polyps (SSP) with or without dysplasia, hyperplastic polyps (HP) and traditional serrated adenomas (TSA). In 2010 the World Health Organization (WHO) defined this syndrome by any one of the following conditions: criterion I, at least 5 SLs proximal to the sigmoid colon with 2 or more of these being \>10mm in size; criterion II, any SLs proximal to the sigmoid colon in a first-degree relative with SPS; criterion III, more than 20 SLs of any size distributed throughout the colon. It has been demonstrated that 11.8-28.5% of patients with SPS present with colorectal cancer (CRC) at diagnosis. Tandem colonoscopy studies have demonstrated that a significant number of lesions are missed during conventional colonoscopy. This finding is even more evident when focusing SLs where a 31% miss rate has been reported. SLs are often overlooked due to their typical appearance: flat morphology, similar colour to the surrounding mucosa, subtle and indistinctive borders. Chromoendoscopy (dye spraying onto the surface of the colon) enhances the detection of subtle and flat polyps in the colon. Until the date no studies have assessed the use of dye-based chromoendoscopy in SPS patients. The aim of this trial was to evaluate the usefulness of panchromoendoscopy with indigo carmine for the detection of polyps in the colon in patients with SPS. Secondary aims were to estimate the SLs and adenoma miss rates in these patients. Patients were randomized in a 1:1 distribution to one of the two arms of the study by a list of random numbers distributed by the coordinator center. After randomization, patients were submitted to tandem colonoscopies by the same endoscopist: * In group A (HR-WLE) the first inspection was on high-resolution white-light endoscopy from the cecum/ileo-colonic anastomosis to the rectum, followed by a second inspection also on HR-WLE. * In group B (HR-CE) the first inspection was on HR-WLE from the cecum/ileo-colonic anastomosis to the rectum, followed by a second inspection with panchromoendoscopy. For this, the lumen was sprayed in a segmental fashion using 0.4% indigo carmine delivered via a specially designed dye spray catheter (Olympus PW-5V1) or via the accessory channel with a 50cc syringe filled with indigo carmine and air. After allowing a few seconds for the dye to settle onto the mucosal surface, excess pools of indigo carmine were suctioned and the mucosa was then scrutinised. Time to withdrawal from the cecum was measured using a stopwatch excluding time needed for polypectomy and biopsies. Lesions detected during each inspection were described and then removed. Size (measured in comparison with an open biopsy forceps), morphology (using the Paris classification), location and polypectomy technique were recorded before removal. Histology was used as gold standard. Conditions: Colonic Polyp, Colonic Neoplasms, Colonic Cancer Intervention / Treatment: DEVICE: chromoendoscopy with indigo carmine Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients with Serrated Polyposis Syndrome aged 18 years or older, fulfilling WHO criteria I or III. * Clearing of all polyps previously achieved. Polyp "clearing" considered when all polyps >3 mm were removed during previous colonoscopies and/or partial colonic surgery when needed. * Surveillance colonoscopy. Exclusion Criteria: * Inflammatory bowel disease. * Hereditary CRC syndromes (i.e, APC, MUTYH - biallelic - and MMR genes germline mutations). * Total colectomy. * Decline for participation.

Study Objectives This qualitative study explores how patients deal with the side effects from chemotherapy at their home, what factors and ideas influence their symptom self-management and how professional caregivers contribute to the management of their symptoms at home. Data are collected through semi-structured interviews with adult patients treated with chemotherapy and analysed using a Grounded Theory approach. Conditions: Exploration of How Patients Deal With Side Effects From Chemotherapy Intervention / Treatment: OTHER: No intervention Location: Belgium Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Adult (≥18 years) patients with (any type and any stage of) cancer who were undergoing chemotherapy treatment in an ambulatory setting or during short hospital stays * Dutch speaking * Able to provide informed consent and to participate in an interview Exclusion Criteria: * Patients who were in the first 2 cycles of treatment * Patients for whom an interview was considered physically, mentally and/or emotionally too burdensome. * Patients who had reported not to experience any side effect from treatment at all

Study Objectives With the increased availability of next-generation sequencing, oncologists are starting to incorporate genomic profiling into routine care of cancer patients. If a genomic alteration is identified during profiling, it could help guide the choice of therapy and improve treatment outcomes. This study will examine the anti-tumor activity of selected commercially available molecularly matched targeted therapies in patients who have failed first-line treatment for one of the following tumor types: non-small cell lung cancers; urothelial cancer; non-colon gastrointestinal cancers, and upper aerodigestive tract cancer. Conditions: Non-small Cell Lung Carcinoma, Urothelial Carcinoma, Gastrointestinal Carcinoma, Non-colon, Upper Aerodigestive Tract Carcinoma Intervention / Treatment: DRUG: Afatinib, DRUG: Regorafenib, DRUG: Cabozantinib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients with a histologically or cytologically confirmed diagnosis of one of the following tumor types whose disease has progressed following one line of standard therapy and/or for which no standard treatment is available that has been shown to prolong survival: 1. Non-small cell lung cancer 2. Urothelial carcinoma 3. Non-colon gastrointestinal cancers (including hepatobiliary, pancreatic, and gastroesophageal tumors) 4. Upper aerodigestive tract cancers (including lip, tongue, salivary gland, gum, oral cavity, mouth, tonsils, oropharynx, nasopharynx, nasal cavity, sinus, and larynx tumors) * Patients must have a predefined genomic alteration that can be targeted with any of the FDA-approved targeted agents used in this study. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Age greater than or equal to 18 years. * Adequate hematologic function defined as: * Absolute neutrophil count (ANC) ≥1500/μL * Platelets ≥75,000/μL * Adequate liver function defined as: * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x the upper limit of normal (ULN) or ≤ 5.0 X ULN if liver metastases present * Total bilirubin ≤1.5 x ULN (unless the patient has Grade 1 bilirubin elevation due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin) * Adequate renal function defined as serum creatinine ≤1.5 x the upper limit of normal OR measured or calculated creatinine clearance ≥50 mL/min for patients with creatinine levels greater than or equal to 1.5 x the upper limit of normal. * Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to receive either regorafenib or afatinib provided that their medication dose and INR/PTT are stable. Close monitoring is mandatory if the patient is receiving anticoagulants. If values are above the therapeutic range the anticoagulant doses should be modified and assessments should be repeated until stable. * Male patients with female partners of childbearing potential and women patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 90 days following last dose of study drug(s). Male patients must also refrain from donating sperm during their participation in the study and for 90 days after the last dose of study drug. * Willingness and ability to comply with study and follow-up procedures. * Ability to understand the nature of this study and give written informed consent. Exclusion Criteria: * Two or more prior chemotherapy regimens in the metastatic setting. * Most recent chemotherapy ≤ 3 weeks and > Grade 1 chemotherapy-related side effects, with the exception of neuropathy (> grade 2 excluded) and alopecia. * Use of a study drug or targeted therapy ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of study treatment. For study drugs for which 5 half-lives is ≤21 days, a minimum of 10 days between termination of the study drug and administration of study treatment is required. * Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study drug or has not recovered from side effects of such therapy. * Major surgical procedures ≤28 days of beginning study drug, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement. * Previously untreated brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed at least 2 weeks prior to study entry and there is no evidence of central nervous system disease progression, mild neurologic symptoms, and no requirement for chronic corticosteroid therapy. Enzyme-inducing anticonvulsants are contraindicated. * Pregnant or lactating * Acute or chronic liver, renal, or pancreas disease. * Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy. * Any of the following cardiac diseases currently or within the last 6 months: * Unstable angina pectoris * Congestive heart failure (New York Heart Association (NYHA) ≥ Grade 2 * Acute myocardial infarction * Conduction abnormality not controlled with pacemaker or medication * Significant ventricular or supraventricular arrhythmias (patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible) * Valvular disease with significant compromise in cardiac function * Inadequately controlled hypertension. * Thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of treatment. * Evidence or history of bleeding diathesis or coagulopathy; any haemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of treatment. * For patients receiving cabozantinib only: Do not administer cabozantinib to patients that have high risk or at high risk for severe haemorrhage. Examples include: 1. The patient has radiographic evidence of cavitating pulmonary lesion(s). 2. The patient has tumor invading or encasing any major blood vessels. 3. The patient has had hemoptysis of ≥ 0.5 teaspoon (2.5ml) of red blood within 3 months before the first dose of study treatment. 4. The patient has experienced clinically significant GI bleeding within 6 months of the first dose of study treatment. 5. The patient has experienced any other signs indicative of pulmonary hemorrhage within 3 months of the first dose of study treatment. * For patients receiving cabozantinib only: Do not administer cabozantinib to patients that have high risk or at high risk of perforation or fistula: 1. The patient has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (eg, Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction. 2. Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose. 3. The patient has pre-existing fistula of head and neck area. Note: Treatment areas should be healed with no sequelae from prior radiation therapy that would predispose to fistula formation. 4. The patient has pre-existing osteonecrosis of the jaw. * Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors. \[Patients receiving cabozantinib only\] * Note: Low-dose aspirin for cardioprotection (per local applicable guidelines), low-dose warfarin (< 1 mg/day), and low dose, low molecular weight heparins (LMWH) are permitted. Anticoagulation with therapeutic doses of LMWH is allowed in subjects without radiographic evidence of brain metastasis, who are on a stable dose of LMWH for at least 12 weeks before randomization, and who have had no complications from a thromboembolic event or the anticoagulation regimen.Presence of a non-healing wound, non-healing ulcer, or bone fracture. * Patients with phaeochromocytoma. * Serious active infection at the time of treatment, or another serious underlying medical condition that would impair the ability of the patient to receive protocol treatment. * Known diagnosis of human immunodeficiency virus, hepatitis B, or hepatitis C. * Presence of other active cancers unless indolent and not requiring therapy. Patients with Stage I cancer who have received definitive local treatment and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma are eligible, as are patients with history of non-melanoma skin cancer. * Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.

Study Objectives This is a multicentre, non-interventional, prospective study to be carried out in representative hospitals in order to assess 1st line treatment management and diagnostic approaches applied to ovarian, peritoneal and fallopian tube cancer management in Russia and assess patients' characteristics and the occurrence of BRCA (Breast Cancer gene) mutations among Russian women with serous and endometrioid ovarian, peritoneal and fallopian tube cancer. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice. Conditions: Ovarian, Peritoneal, Fallopian Tube Cancer, BRCAm+ in Russia Location: Russian Federation Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * The voluntary obtained informed consent signed by both the subject and the investigator. * Confirmed serous and endometrioid ovarian cancer or fallopian tube cancer or peritoneal cancer diagnosed 3 months before enrolment into the study or later * Patients on treatment for OC (Ovarian Cancer) or FTC (Fallopian Tube Cancer) or PC (Peritoneal Cancer) Exclusion Criteria: * The ovarian cancer histology other than serous and endometrioid. * Patients participating in clinical studies. * Any medical condition which on the opinion of the investigator may interfere the patient's participation in the trial.