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Study Objectives The main purpose of this study is to evaluate the safety and efficacy of the study drug known as galunisertib administered in combination with the anti-programmed cell death-ligand 1 (PD-L1) antibody durvalumab in participants with refractory metastatic pancreatic cancer. Conditions: Metastatic Pancreatic Cancer Intervention / Treatment: DRUG: Galunisertib, DRUG: Durvalumab Location: Spain, United States, Italy, France, Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Must have histologic or cytologic confirmation of recurrent metastatic pancreatic adenocarcinoma based on standard diagnostic criteria. Recurrence must be documented by diagnostic biopsy. * Have measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. * Have had disease progression, been refractory or intolerant to no more than 2 prior systemic regimens for locally advanced or metastatic pancreatic cancer. Participants who have received prior neoadjuvant therapy and who now have metastatic disease must have received 1 of the following for their metastatic disease: FOLFIRINOX, nanoparticle albumin-bound paclitaxel/gemcitabine, TS-1 (tegafur gimeracil oteracil potassium), irinotecan liposome injection/5-fluorouracil (5FU)/Leucovorin or single-agent gemcitabine prior to enrolment in this study. * Dose Escalation: Able and willing to give valid written consent to undergo a new tumour biopsy (prior to study treatment) or to provide an available archival tumour sample if taken <3 years prior to enrolment if a new tumour biopsy is not feasible with an acceptable clinical risk. * Cohort Expansion: Able and willing to give valid written consent to undergo a new tumour biopsy (prior to study treatment). Able and willing to undergo a second tumour biopsy on treatment. Where possible, tumour lesions used for new biopsies should not be the same lesions used as RECIST target lesions, unless there are no other lesions suitable for biopsy. Archival samples may be required if there is inadequate tissue in the biopsy specimen. * Have adequate organ function. * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale. * Use approved contraceptive methods. Exclusion Criteria: * Have moderate or severe cardiovascular disease: * Have the presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled hypertension. * Have documented major electrocardiogram (ECG) abnormalities (not responding to medical treatments; for example, atrial fibrillation, bundle branch blocks, or as approved by the sponsors). * Have major abnormalities documented by ECHO with Doppler (for example, moderate or severe heart valve function defect including moderate or severe valve stenosis or regurgitation, left ventricular ejection fraction <50%, evaluation based on the institutional lower limit of normal, septal aneurysm or other heart aneurysm, any aneurysm of the major vessels or any condition that results in increased risk of aneurysm (eg, Marfan syndrome, patent foramen ovale \[PFO\]). * Have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress (for example, family history of aneurysms, Marfan syndrome, PFO, bicuspid aortic valve, evidence of damage to the large vessels of the heart documented by computerized tomography \[CT\] scan with contrast or magnetic resonance imaging \[MRI\]). * Have evidence of interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity or active, noninfectious pneumonitis.

Study Objectives Background: Hepatocellular carcinoma (HCC) is the most common primary liver cancer with aggressive tumor behavior. Radiofrequency ablation (RFA) or microwave ablation (MWA) is an effective curative treatment for early stage HCC. This thermal ablation of liver tumor induces host immune response with changes in serum concentration of various cytokines. It is not clear whether this host immune response correlates with tumor recurrence and long-term patient survival. Objective: This prospective study is to investigate the change of cytokines' level following RFA or MWA for HCC and its clinical correlation with tumor recurrence and patients' long-term survival data. Hypothesis: Thermal ablation of HCC creates tumor antigen source for the generation of antitumor immunity and enhances host immune responses. The resulting inflammation and changes in cytokines may augment tumor cell death by increasing neutrophil infiltration and oxidative burst mechanisms. On the other hand, there may be negative effects via the production of growth factors, which could stimulate tumor cell growth within the sub-lethal margin. Therefore, the ultimate clinical consequences would be significantly affected by these immune responses. Study design: This is a prospective study on the measurement of changes of serum cytokines in patients with HCC undergone RFA or MWA using the commercially available kit (MILLIPEX, Human cytokine/chemokine magnetic bead panel - Immunology Multiplex Assay ), which measure 10 cytokines, including IL-1β, IL-6, IL-10, IL-12 (p40), IL-12 (p70), TNF-α, CXCL8, CXCL9, CXCL10, CCL2, CCL5. Statistical correlation will be performed between the cytokine change and long-term patients' clinical outcome using the prospectively collected database. Subjects: Patients with HCC undergone RFA or MWA in the Department of Surgery, The Chinese University of Hong Kong will be recruited. Exclusion criteria were evidence of extrahepatic metastasis, patients receiving combined hepatectomy and other local ablative therapy and patients with decompensated liver function that preclude local ablative treatment. Intervention: RFA or MWA will be performed for patients with HCC. The serum samples of all consecutive recruited patients will be collected prospectively during the intervention. The measurement of cytokines level will be performed in the Laboratory of Department of Chemical Pathology, The Chinese University of Hong Kong under the standard protocol. Main outcome measures: Primary outcome measure is early intrahepatic tumor recurrence within one year after thermal ablation. Secondary outcome measures are other tumor recurrence pattern (late intrahepatic recurrence and extrahepatic metastasis), overall survival and recurrence-free survival. Data analysis: All data will be prospectively collected by a research assistant and computerized in a database. Statistical analysis will be performed by Chi-square test or Fisher's exact test, where appropriate, to compare discrete variables and Mann-Whitney U test to compare continuous variables. Cumulative survival will be computed by the Kaplan-Meier method and compared by Log-rank test. Multivariable analysis using logistic regression model will be done to identify the independent prognostic factors affecting early tumor recurrence. Expected results: Understanding the relationship between the cytokines change during thermal ablation and post-treatment tumor recurrence helps to identify high risk patients for the possible adjuvant therapy in future study. Conditions: Hepatocellular Carcinoma Intervention / Treatment: DEVICE: Radiofrequency ablation or microwave ablation Location: Hong Kong Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Consecutive patients with HCC undergoing RFA or MWA will be recruited into this study provided the following criteria are fulfilled. 1. HCC of maximal diameter < 8cm, and/or 2. Multiple tumor nodules < 5, and/or 3. Normal liver (serum total bilirubin level < 50 umol/L and serum albumin > 30 g/L) and renal function (serum creatinine level <120 mmol/L) 4. Child-Pugh class A or B Exclusion Criteria: * Evidence of extrahepatic metastasis * Patients receiving combined hepatectomy and other local ablative therapy * Patients with decompensated liver function that preclude local ablative treatment. * Patients with previous treatment for HCC (TACE, radiofrequency ablation, high intensity focus ultrasound or systemic chemotherapy) * Patients with inadequate serum sample for cytokine analysis

Study Objectives 1. Understanding the smoking change patterns among the newly diagnosis lung cancer patients after cancer diagnosis. 2. Explore the related factors of the smoking change patterns. 3. The type of smoking trajectory impact on survival and quality of life. Conditions: Newly Diagnosed Lung Cancer, Smoking, Cigarette, Survival, Quality of Life Intervention / Treatment: BEHAVIORAL: smoking Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Over 20 years old * Newly diagnosed lung cancer * Conscious clear and able to communicate * Agreed to participate the study Exclusion Criteria: * Consciously confused * Cognitive or psychotic disorders

Study Objectives Integrated PET/MRI has the advantage to assess the metabolism, diffusion, and perfusion parameters of the tumor simultaneously. Recently, PET/MRI has been investigated in several cancers with promising results. In this study, we prospectively investigate the role of multiparametric PET/MRI in evaluating the outcome of patients with esophageal cancer treated by neoadjuvant chemoradiotherapy and surgery. Conditions: Esophageal Cancer Intervention / Treatment: DIAGNOSTIC_TEST: PET/MRI Location: Taiwan Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Biopsy-proven primary esophageal cancer * Willing to receive therapy * The ability to provide written informed consent and receive the scheduled scans Exclusion Criteria: * Woman with pregnancy or during lactation * A history of other malignancies or concomitant cancers in different anatomical locations * Not suitable to receive the PET scan such as serum glucose levels of > 200 mg/dL or space phobia

Study Objectives Patients with first recurrent resistance ovarian cancer and disease progression with peritoneal carcinomatosis will undergo PIPAC procedure. The primary end point is to determine the clinical benefit rate (CBR) of a pressurized intraperitoneal aerosol chemotherapy with a combination of cisplatin and doxorubicin. Conditions: Ovarian Epithelial Cancer Recurrent, Platinum-resistant Intervention / Treatment: DEVICE: Pressurized intraperitoneal aerosol chemotherapy with cisplatin and doxorubicin Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients affected by first or second platinum resistant epithelial ovarian tumor recurrence. * ECOG-performance status ≤ 3. * Adequate respiratory, hepatic, cardiac, kidney and bone marrow function (absolute neutrophil count > 1500 / mm3, platelets > 150 000/μl, creatinine clearance > 60 mL / min according to Cockroft formula). * Patient-compliant and psychologically able to follow the trial procedures. Exclusion Criteria: * Non-epithelial ovarian cancer or borderline ovarian tumor. * Pregnancy or breastfeeding. * Patients affected by major depressive disorder even in treatment or minor mood disorders. * Patients with severe impairment of respiratory, hepatic or renal function. * Patients with cardiac, neurological or metabolic uncontrolled pharmacologically disease * Patients with bowel obstruction. * Inadequate bone marrow, liver, kidney function. * No clear-peritoneal disease at surgical exploration. * Patients with ascites >2000 cc (CT-Scan) * Patients who have already made third line chemotherapy.

Study Objectives This phase Ib trial studies side effects and best dose of pevonedistat when given together with ixazomib in treating patients with multiple myeloma that has come back or does not respond to treatment. Pevonedistat and ixazomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Conditions: Recurrent Multiple Myeloma, Refractory Multiple Myeloma Intervention / Treatment: DRUG: Ixazomib Citrate, DRUG: Pevonedistat 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: * Patients must have RRMM with measurable disease, as defined by at least one of the following: * Serum monoclonal protein >= 0.5 g/dL * Urinary monoclonal protein excretion of >= 200 mg/24 hours * Kappa or lambda light chain level >= 10 mg/dL with an abnormal free light chain ratio * At least two prior lines of therapy and all patients should have at least been exposed to a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody. * For proteasome-sensitive expansion cohort: Patients with MM who relapsed or are refractory to a prior line of therapy not including a proteasome inhibitor * For proteasome-relapsed/refractory expansion cohort: Patients with MM who have relapsed after prior PI exposure or are PI-refractory, defined as nonresponsive to treatment or progresses within 60 days of last exposure to a PI * Age >= 18 years * Because no dosing or adverse event (AE) data are currently available on the use of MLN4924 (pevonedistat) in combination with MLN9708 (ixazomib) in patients < 18 years of age, and as this disease is exceptionally uncommon in this age group, children are excluded from this study * Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) * Leukocytes >= 3,000/mcL * Absolute neutrophil count >= 1,000/mcL * Platelets >= 75,000/mcL * Bilirubin =< institutional upper limit of normal (ULN). * Patients with Gilbert's syndrome may enroll if direct bilirubin =< 1.5 x ULN * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =< 3.0 x institutional ULN * Creatinine clearance (CrCl) by Cockcroft-Gault >= 30 mL/min * Known human immunodeficiency virus (HIV) positive patients who meet the following criteria will be considered eligible: * CD 4 count > 350 cells/mm\^3 * Undetectable viral load * Maintained on modern therapeutic regimens utilizing non-CYP-interactive agents (e.g. excluding ritonavir) * No history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections * The effects of MLN4924 (pevonedistat) and MLN9708 (ixazomib) on the developing human fetus are unknown. For this reason and because NAE inhibitory agents are known to be teratogenic, women of child-bearing potential and men must meet the following criteria: * Female patients who are: * Postmenopausal for at least one year before the screening visit, OR * Surgically sterile, OR * If of childbearing potential, agree to practice 1 highly effective method and 1 additional (barrier) method of contraception, at the same time, from the time of signing the informed consent until 4 months after the last dose of the ixazomib and pevonedistat (female and male condoms should not be used together), or agree to abstain from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject (Periodic abstinence \[e.g,, calendar, ovulation, symptothermal, postovulation methods\] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception) * Male patients, even if surgically sterilized, who: * Agree to practice effective barrier contraception during the entire time enrolled on study through 4 months after completion of ixazomib and pevonedistat administration (female and male condoms should not be used together), OR * Agree to abstain from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner\] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception) * 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 * Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and/or family member available will also be eligible Exclusion Criteria: * Diagnosed or treated for another malignancy within 2 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone resection * Patients who are receiving any other investigational agents, within 30 days of the start of this trial and throughout the duration of this trial * Patients with known central nervous system involvement should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other AEs * History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN4924 (pevonedistat) or MLN9708 (ixazomib) (including boron or boron-containing products) * Patients with uncontrolled intercurrent illness * Pregnant women are excluded from this study because MLN4924 (pevonedistat) is an NAE inhibitory agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with MLN4924 (pevonedistat), breastfeeding should be discontinued if the mother is treated with MLN4924 (pevonedistat). These potential risks may also apply to the use of MLN9708 (ixazomib) in this study * Major surgery within 14 days before the first dose of any study drug or a scheduled surgery during study period * Patients with uncontrolled coagulopathy or bleeding disorder * Known hepatic impairment as defined by known hepatic cirrhosis, hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection * Note: Patients who have isolated positive hepatitis B core antibody (i.e., in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load. Patients who have positive hepatitis C antibody may be included if they have an undetectable hepatitis C viral load * Known cardiopulmonary disease defined as: * Unstable angina; * Congestive heart failure (New York Heart Association \[NYHA\] class III or IV); * Myocardial infarction within 6 months prior to first dose (patients who had ischemic heart disease such as acute coronary syndrome \[ACS\], myocardial infarction, and/or revascularization greater than 6 months before screening and who are without cardiac symptoms may enroll); * Symptomatic cardiomyopathy * Clinically significant arrhythmia: * History of polymorphic ventricular fibrillation or torsade de pointes, * Permanent atrial fibrillation, defined as continuous atrial fibrillation for >= 6 months, * Persistent atrial fibrillation, defined as sustained atrial fibrillation lasting > 7 days and/or requiring cardioversion in the 4 weeks before screening, * Grade 3 atrial fibrillation defined as symptomatic and incompletely controlled medically, or controlled with device (e.g., pacemaker), or ablation in the past 6 months and * Patients with paroxysmal atrial fibrillation or grade < 3 atrial fibrillation for period of at least 6 months are permitted to enroll provided that their rate is controlled on a stable regimen * Clinically significant pulmonary hypertension requiring pharmacologic therapy * Uncontrolled high blood pressure (i.e., systolic blood pressure > 180 mmHg, diastolic blood pressure > 95 mmHg) * Prolonged rate corrected QT (QTc) interval >= 500 msec, calculated according to institutional guidelines * Left ventricular ejection fraction (LVEF) < 50% as assessed by echocardiogram * Known moderate to severe chronic obstructive pulmonary disease, interstitial lung disease, and pulmonary fibrosis * Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of MLN9708 (ixazomib), including difficulty swallowing * Peripheral neuropathy that is grade >= 3, or grade 2 with pain on clinical examination during the screening period * Patients that have previously been treated with MLN9708 (ixazomib) * Systemic treatment, within 14 days before the first dose of MLN9708 (ixazomib), with strong CYP3A inducers (rifampin, rifapentine, rifabutin, ritonavir, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort. Clinically significant metabolic enzyme inducers are not permitted during this study * Radiotherapy within 14 days before enrollment. If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708 (ixazomib) * Female patients who intend to donate eggs (ova) during the course of this study or 4 months after receiving their last dose of study drug(s) * Male patients who intend to donate sperm during the course of this study or 4 months after receiving their last dose of study drug(s)

Study Objectives Individuals on oral chemotherapy (OC) often face many challenges requiring adequate informational support, monitoring, and management. This pilot randomized control trial (RCT) aims to assess the feasibility, acceptability, and preliminary effects of a comprehensive OC intervention on medication adherence self-efficacy, medication adherence, and symptom distress. Conditions: Oral Chemotherapy Intervention / Treatment: OTHER: Oral chemotherapy information and support Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * 18 years of age or older * Diagnosis of cancer, any stage * Being followed by a care team at the affiliated hospital centre * About to start or within the first cycle of oral anticancer treatment (traditional cytotoxic, targeted therapy, hormonal therapy as active ongoing treatment for cancer with the aim of killing cancer cells/shrinking tumor size) * Has a computer/tablet/smartphone device with internet * The ability to communicate, read, and write in English or French Exclusion Criteria: * Receiving IV chemotherapy, immunotherapy, and/or oral hormonal therapy as long-term maintenance treatment for prevention of cancer's return/growth of cancer cells after initial treatment * Significant physical or cognitive limitations that would prevent ability to participate in study as reported by patient, primary healthcare provider, or research staff * At imminent "end-of-life" * Participating in an ongoing clinical trial

Study Objectives Resection of brain tumors in eloquent areas involves the risk of postoperative motor deficits. For brain tumors within or adjacent to the eloquent area, maximizing tumor resection while preserving motor function is crucially important.we used DTI-based tractography to visualize the spatial relationship between brain lesions and the nearby pyramidal tract(PT) in patients with malignant brain tumors and confirmed functional connections of the illustrated PT by direct electrical stimulation. We evaluated the reliability of DTI-based tractography for PT mapping using intraoperative subcortical stimulation ) and the usefulness of the combination of two techniques. Conditions: Glioma, Motor Pathway Intervention / Treatment: PROCEDURE: diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: SINGLE

Inclusion Criteria: * patients with an initial imaging diagnosis of single, unilateral, supratentorial primary glioma (or intrinsic neoplasm). * The lesions were involved in PTs, comprising cortical regions in the motor or somatosensory areas, cortical regions adjacent to the central gyrus, subcortical regions with an infiltrative progression along the PTs, and temporal or insular regions in relation to the internal capsule. * MRI enabled preoperative identification of patients in whom maximal tumor resection was likely to be achieved, and close PT approach within resection cavity at the time of surgery was possible. Exclusion Criteria: * patients with secondary or recurrent gliomas (or intrinsic neoplasm), patients with contraindications for MRI or direct electrical stimulation, and patients in whom initial muscle strength grades of the affected extremities was 2/5 or lower.

Study Objectives This study is a large observational study, set-up to observe how long-term treatment with FIRMAGON (hormone regulator) compare to other treatments in regards to cardiovascular events, changes in bone density, changes in blood sugar levels or liver enzyme levels in subjects with prostate cancer. Subjects will be treated according to their routine clinical care and not dictated by the study. As the study is observational in nature, the study will collect data relating to the events specified above. Subjects that agree to this study will be followed-up for 5 years. Subject data will be collected every 3 months for the first 2 years and every 6 months for the last 3 years. Conditions: Prostate Cancer Location: Portugal, Norway, Ireland, Italy, Germany, Denmark, France, Greece, Belgium, Netherlands, Switzerland, Finland, Hungary, Slovakia, United Kingdom Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Diagnosed with prostate cancer and indicated for androgen deprivation therapy (ADT) * Decision made to prescribe ADT prior to enrolment * Willing and able to provide written informed consent Exclusion Criteria: * Participation in an interventional clinical study in which any treatment or follow-up is mandated * Treatment with a GnRH receptor antagonist other than FIRMAGON * Had previous or is currently under hormonal management of prostate cancer, except for subjects who have undergone therapy with curative intention where neoadjuvant/adjuvant therapy allowed for maximum 6 months. Treatment should be terminated at least 6 months prior to baseline.

Study Objectives This phase I trial studies the side effects and best dose of inotuzumab ozogamicin when given together with combination chemotherapy in treating patients with relapsed or refractory acute leukemia. Immunotoxins, such as inotuzumab ozogamicin, can find cancer cells that express cluster of differentiation (CD)22 and kill them without harming normal cells. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving inotuzumab ozogamicin together with combination chemotherapy may kill more cancer cells. Conditions: Acute Leukemias of Ambiguous Lineage, B-cell Adult Acute Lymphoblastic Leukemia, Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Burkitt Lymphoma Intervention / Treatment: DRUG: cyclophosphamide, DRUG: vincristine sulfate, DRUG: prednisone, BIOLOGICAL: inotuzumab ozogamicin, OTHER: laboratory biomarker analysis 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: * Patients must have a diagnosis of relapsed or refractory CD22-positive acute leukemia including B-ALL, mixed phenotype leukemia (biphenotypic), or Burkitt's leukemia based on World Health Organization (WHO) classification; patients with bilineal leukemia are excluded * Patients must have evidence of acute leukemia in their peripheral blood or bone marrow; patients must have >= 5% blasts in the peripheral blood or bone marrow within 14 days prior to registration; at least >= 20% of those blasts must be CD22-positive (surface) based on local immunophenotyping and histopathology * Patients must be refractory or have relapsed following prior induction therapy; a standard induction regimen is defined as any program of treatment that includes vincristine and prednisone or dexamethasone, cytarabine/anthracycline, or high dose cytarabine * For sites with the B1931022 pharmaceutical trial open, precursor B-cell ALL patients from that site may be eligible for S1312 providing they meet the following criteria: * Patient is in second salvage or more; OR * Patient was treated on the standard of care arm of B1931022 and failed therapy * Patients may have received prior allogeneic transplant or autologous transplant; however, patients with prior allogeneic bone marrow transplant will be eligible only if both of the following conditions are met: * The transplant must have been performed >= 90 days prior to registration * The patient must not have >= grade 2 acute graft versus host disease (GvHD) or either moderate or severe limited chronic GvHD within 14 days prior to registration * Patients known to have Philadelphia chromosome positive (Ph+) ALL must have either failed treatment or been intolerant to treatment with at least two second or third generation tyrosine kinase inhibitors * Patients must not have received prior treatment with inotuzumab ozogamicin; previous treatment with other anti-CD22 antibodies must have been completed at least 90 days prior to registration * Patients must have Zubrod performance status 0-2 * Patients must not have received any chemotherapy, investigational agents, or undergone major surgery within 14 days prior to registration with the following exceptions: * Monoclonal antibodies must not have been received for 1 week prior to registration * Chimeric antigen receptor (CAR) T-cells must not have been received for 28 days prior to registration. * Steroids, hydroxyurea, vincristine, 6-mercaptopurine, methotrexate, thioguanine and intrathecal chemotherapy are permitted within any time frame prior to registration. FDA-approved TKIs may also be administered until 1 day prior to start of study therapy (C1, D1). * All drug-related toxicities must have resolved to =< grade 2 * Patients must not have a systemic bacterial, fungal, or viral infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement despite appropriate antibiotics or other treatment) * Patients must not have any other serious concurrent disease or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that would put the patient at undue risk of undergoing therapy * Patients must not have active central nervous system (CNS) involvement (by clinical evaluation); patients with previous documented history of CNS involvement of acute leukemia, or with clinical signs or symptoms consistent with CNS involvement of acute leukemia, must have a lumbar puncture which is negative for CNS involvement of acute leukemia; the lumbar puncture must be completed within 14 days prior to registration; patients with no previous history of documented CNS involvement and with no clinical signs or symptoms consistent with CNS involvement are not required to have completed a lumbar puncture before registration; note that treatment with intrathecal therapy is recommended during protocol treatment but CNS analysis during treatment is not required * Patients must have a peripheral blast count < 25,000/uL within 2 days prior to registration; (treatment with hydroxyurea and steroids is permitted to bring the countdown) * Patients must have serum creatinine =< 2 x institutional upper limits of normal (IULN) within 7 days prior to registration * Patients must have bilirubin =< 2 x IULN within 7 days prior to registration (unless the bilirubin is primarily unconjugated) * Patients must have < grade 2 neuropathy (sensory/motor) within 7 days prior to registration * Patients must have serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =< 2.5 x IULN within 7 days prior to registration * Patients with a history of a serious allergic or anaphylactic reaction to humanized monoclonal antibodies are not eligible * Patients must not have a history of chronic or active hepatitis B or C infection; patients must have negative hepatitis B and C serologies performed within 28 days prior to registration * Patients must not have evidence or history of veno-occlusive disease or sinusoidal obstruction syndrome * Patients must not have a cardiac ejection fraction < 45% or the presence of New York Heart Association stage III or IV heart failure within 14 days prior to registration; either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) may be used to determine ejection fraction * Patients must not have a myocardial infarction within 6 months prior to registration * Patients must not have a history of clinically significant arrhythmia, prolonged corrected QT (QTc) interval, or unexplained syncope not thought to be vasovagal in nature within 6 months prior to registration * Patients must not have a screening corrected QT using Fridericia's formula (QTcF) interval > 500 milliseconds (by Fridericia calculation) based on the average of triplicate electrocardiogram (EKG) performed within 7 days prior to registration; note that triplicate EKG is required at other timepoints * Patients must not have a history of chronic liver disease (or cirrhosis) * Patients who are known to be human immunodeficiency virus (HIV)+ are eligible providing they meet all of the following additional criteria within 28 days prior to registration: * CD4+ cells >= 350/mm\^3 (nadir) * Viral load of < 50 copies HIV messenger ribonucleic acid (mRNA)/mm\^3 if on combination antiretroviral therapy (cART) or < 25,000 copies HIV mRNA if not on cART * No zidovudine or stavudine as part of cART Patients who are HIV+ and do not meet all of these criteria are not eligible for this study * Patients with evidence of extramedullary disease at diagnosis will have computed tomography (CT) scan of the chest, abdomen and pelvis to obtain baseline values within 28 days prior to registration * Patients must have complete history and physical examination within 28 days prior to registration * Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures * Prior malignancy other than acute leukemia is allowed, provided it is in remission and there is no plan to treat the malignancy at the time of registration * Pretreatment cytogenetics must be performed on all patients; collection of pretreatment specimens must be completed within 14 days prior to registration to S1312; specimens must be submitted to the site's preferred Clinical Laboratory Improvement Amendments (CLIA)-approved cytogenetics laboratory; reports of the results must be submitted as described; note that cytogenetics are required at other time points * Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system * Patients planning to enroll in this study must first have a slot reserved in advance of the registration; all site staff will use OPEN to create a slot reservation

Study Objectives This is a Phase Ib/II study to identify the recommended dose of paclitaxel and nivolumab for further study, and to assess the safety and clinical efficacy of this combined treatment in EBV-related, MSI-high, or PD-L1 positive advanced gastric cancer after first line treatment. Conditions: Recurrent/Metastatic Gastric Cancer Intervention / Treatment: DRUG: Nivolumab, Paclitaxel Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Has provided digned written informed Consent * Is male or female ≥19 years of age * Has a histologically or cytologically confirmed diagnosis of advanced gastric adenocarcinoma * Has documented EBV-related, MSI-high, or PD-L1 positive tumor in primary or metastatic tumor tissue * Has a life expectancy of at least 3 months * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Has measurable or evaluable disease as determined by RECIST 1.1. * Is able to swallow and retain orally administered medication * Has an adequate baseline organ function defined as: * White blood cells ≥3000/mm3 and neutrophils ≥1500/mm3 * Platelets ≥100000/mm3 * Hemoglobin ≥9.0 g/dL * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × upper limit of normal (ULN) of the study site (or ≤5.0 × ULN in patients with liver metastases) * Total bilirubin ≤2.0 × ULN * Creatinine≤1.5 × ULN or creatinine clearance (either measured value or estimated value using the Cockcroft-Gault equation) >60ml/min. Exclusion Criteria: * Has HER2-positive or indeterminate gastric cancer * Have multiple cancers * Have a current or past history of severe hypersensitivity to any other antibody products * Have concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease * Have a current or past history of interstitial lung disease or pulmonary fibrosis diagnosed based on imaging (preferably CT) or clinical findings * Have brain or meninx metastases. Patients may be randomized for the study if they are asymptomatic and require no treatment. * Have pericardial fluid, pleural effusion, or ascites requiring treatment * Have a history of uncontrollable or significant cardiovascular disease * Have systemic infection requiring treatment * Are contraindicated for paclitaxel * Has had prior treatment with: - Require or, within 28 days before treatment, have received systemic corticosteroids or immunosuppressants * Have undergone surgery (any surgery involving general anesthesia) within 28 days before study treatment * Have received radiotherapy for gastric cancer within 28 days before treatment or radiotherapy for bone metastases within 14 days before treatment * Have a positive test result for human immunodeficiency virus-1 (HIV-1) antibody, * Hepatitis B surface protein (HBs) antigen and HBV titer >2000 IU/ml (10,000 copy/ml), or hepatitis C virus (HCV) antibody positive result * Are pregnant or breastfeeding, or possibly pregnant * Has any unresolved ≥Grade 2 (per CTCAE v4.0) toxicity from previous anti-cancer therapy at the time of enrollment such as neuropathy, except alopecia or anemia * Have previously received nivolumab, anti-programmed cell death-1 (PD-1) antibody, anti-PD-L1 antibody, anti-programmed cell death-ligand 2 (PD-L2) antibody, anti-CD137 antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody, or other therapeutic antibodies or pharmacotherapies for the regulation of T-cells * Are incapable of providing consent for specific reasons, such as concurrent dementia * Are otherwise inappropriate for this study in the investigator's or subinvestigator's opinion.

Study Objectives This study was designed in two phases: Phase I is designed to confirm that the surgeon is able to perform accurate liver surface registration including standard liver features used as landmarks during a scheduled laparoscopic liver ablation procedure and acquires a level of comfort with the procedure. The surface of the liver will be manually swabbed with the study tracked laparoscopic probe with landmarks noted during data collection. After registration of the liver is obtained, the registration points obtained during this procedure will be evaluated by the surgeon by moving the tracked laparoscopic probe over the liver surface and evaluating the location of the tracked laparoscopic probe displayed on the guidance system three dimensional (3D) image. The surgeon will accept or reject the registration accuracy. The hypothesis is that the surgeon will be able to successfully acquire liver surface registrations with a small learning curve for technique and will be able to proceed to Phase II of the study. Phase II contains the registration process included above but adds the additional process of tracking the ablation probe used to perform tumor ablation by attaching the Pathfinder Multi-Tool adaptor and collecting data showing the location of the ablation probe as tracked and displayed on the Pathfinder three dimensional (3D) image. The surgeon will use ultrasound (US) guidance to locate tumor location during the laparoscopic procedure. The images collected during this process will be recorded by Pathfinder. Conditions: Liver Cancer Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Scheduled for laparoscopic liver ablation procedure * Had a preoperative CT image that includes the liver Exclusion Criteria: * Severe cirrhosis of the liver * Kidney failure or dialysis * Unable to consent

Study Objectives This investigator driven study will examine the safety, tolerability and efficacy of the combination of 177Lutetium-PSMA (177Lu-PSMA) and pembrolizumab in patients with metastatic Castration Resistant Prostate Cancer (mCRPC). 177Lu-PSMA is a compound that binds to the extra-cellular domain of the prostate-specific membrane antigen. Pembrolizumab is an antibody targeted against anti-programmed cell death 1 (PD-1).This is a single arm study where all patients will be treated with 177Lu-PSMA for upto 6 doses and pembrolizumab for upto 35 cycles. Conditions: Metastatic Castration Resistant Prostate Cancer Intervention / Treatment: DRUG: Pembrolizumab, DRUG: 177Lu-PSMA Location: Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Patients must meet the following criteria for study entry: * Patient who are at least 18 years of age who have provided written informed consent. * Histologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell differentiation. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 (see Appendix 1). * Patients must have progressed on prior enzalutamide, abiraterone and/or apalutamide for treatment of prostate cancer. * Determination of disease progression on second generation androgen receptor targeted agent determined by the local investigator. Progressive disease is defined by PCWG3 as any one of the following: * PSA progression: minimum of two rising PSA values from a baseline measurement with an interval of ≥ 1 week between each measurement. The PSA value at screening should be ≥ 1ng/ml. * Soft tissue or visceral disease progression as per modified RECIST 1.1 criteria (see Appendix 2) * Bone progression: ≥ 2 new lesions on bone scan (Appendix 2) * At least 2 weeks since the completion of surgery or radiotherapy prior to registration. Any clinically relevant sequelae from the surgery or radiotherapy must have improved to grade 1 prior to registration. * Prior surgical orchiectomy or chemical castration maintained on luteinizing hormone-releasing hormone (LHRH) analog (agonist or antagonist). Patients without prior surgical castration must be currently taking and willing to continue luteinizing hormone-releasing hormone (LHRH) analog (agonist or antagonist) therapy throughout the duration of study treatment. * Serum testosterone levels ≤ 50ng/dL. (≤ 1.75nmol/L) within 28 days before registration. * Imaging evidence of metastatic disease documented with either bone scan or CT scan (Appendix 2). * Prior prostate cancer vaccine therapy, radiation therapy, systemic therapies, diethylstilboestrol (DES) or other estrogens are allowed up to 28 days prior to trial registration. Note: bicalutamide flutamide or nilutamide must be discontinued within 4 weeks of registration. * Significant PSMA avidity on 68Ga/18F-PSMA PET/CT, defined as a minimum uptake of SUVmax 20 at a site of disease, and SUVmax > 10 at other sites of disease ≥10mm (unless subject to factors explaining a lower uptake, e.g. respiratory motion, reconstruction artefact). * Patients must have a life expectancy ≥ 24 weeks. * Patients must agree to use a highly effective form of contraception for the entire duration of the study plus an additional 120 days (a spermatogenesis cycle) after the last dose of study treatment and refrain from donating sperm during this period (see section 10.3.3). * Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled assessments. * Patients must have adequate bone marrow, hepatic and renal function documented within 28 days of registration, defined as: * Haemoglobin ≥90 g/L independent of transfusions (no red blood cell transfusion in last 4 weeks) * White blood cells >3x109/L * Absolute neutrophil count ≥1.5x109/L * Platelets ≥100 x109/L * Total bilirubin ≤1.5 x upper limit of normal (ULN) except for patients with known Gilbert's syndrome. * Aspartate transaminase (AST) (SGOT) and alanine transaminase (ALT) (SGPT) ≤2.5 × ULN or ≤5 × ULN for participants with liver metastases. * Serum creatinine ≤1.5 x ULN or a calculated creatinine clearance > 50mL/min (Chronic Kidney Disease Epidemiology (CKD-EPI) equation for patients with creatinine levels above institutional normal. * Albumin >30 g/dl * International normalized ratio (INR), prothrombin time (PT), activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants. * Patients who are deemed by PSMA imaging to have readily accessible disease will be required to consent to 3 serial tumour biopsies - at screening, post combination treatment (at any time between weeks 2-4) and on progression Exclusion Criteria: * Site(s) of disease that are FDG positive with low PSMA expression defined by PSMA SUVmax < 10. * Previous history or presence of brain metastases or leptomeningeal metastases. * Any prior exposure to anti-PD-1, anti-PD-L1/L2, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathway. * Any prior treatment with cabazitaxel. * Any prior exposure to 177Lu-PSMA. * 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. * Patients with active, known or suspected autoimmune disease including Sjogren's syndrome. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are eligible. * Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. * Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy may be eligible. * Patients with a condition requiring systemic treatment with either corticosteroids (> 10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids, and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. * Other malignancies within the previous 2-years other than, melanoma in situ, basal cell or squamous cell carcinomas of skin with a > 30% probability of recurrence within 12 months. * Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection. * Patient has a known history of Human Immunodeficiency Virus (HIV). * Patients with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable for ≥ 4 weeks. * Previous history of interstitial lung disease or non-infectious pneumonitis. * Recent administration of a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. * Recent administration of the influenza vaccine (within 30 days of registration).

Study Objectives This study will compare the safety and efficacy of dalotuzumab (MK-0646) in combination with cetuximab and irinotecan in treating participants with wild type KRAS (wtKRAS) metastatic colorectal cancer (CRC) compared to cetuximab and irinotecan alone. The primary study hypothesis is that administration of dalotuzumab in combination with cetuximab and irinotecan to participants with metastatic CRC expressing the wtKRAS genotype improves Overall Survival OR Progression-free Survival compared to participants treated with cetuximab and irinotecan alone. Conditions: Metastatic Colorectal Cancer Intervention / Treatment: BIOLOGICAL: dalotuzumab, DRUG: irinotecan hydrochloride, BIOLOGICAL: cetuximab, DRUG: placebo Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Participant must have confirmed wtKRAS CRC. * Participant must have previously failed both irinotecan and oxaliplatin containing regimens, and should have progressed on or within 3 months of completing their last line of therapy with objective evidence of progression as verified by previous radiologic scans. Exclusion Criteria: * Participant has had cancer treatment within 2 weeks before the first dose of study drug(s) or if the side effects from the drugs have not gone down to a certain level 2 weeks before the first dose of study drugs. * Participant has had a bad side effect to irinotecan therapy. * Participant has human immunodeficiency virus (HIV). * Participant has Hepatitis B or C. * Participant is pregnant or breast feeding or planning to have a child while on this study.

Study Objectives Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with locally advanced or metastatic pancreatic cancer Conditions: Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer Intervention / Treatment: DRUG: temsirolimus, OTHER: laboratory biomarker analysis 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 adenocarcinoma of the pancreas * Locally advanced or metastatic disease * Radiographic evidence of disease * No known brain metastases * Performance status - ECOG 0-2 * More than 3 months * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present) * Creatinine ≤ 1.5 mg/dL * Creatinine clearance ≥ 50 mL/min * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Fasting serum cholesterol ≤ 350 mg/dL * Fasting triglycerides ≤ 400 mg/dL * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No other concurrent uncontrolled illness * No concurrent prophylactic hematopoietic colony-stimulating factors * No prior chemotherapy for metastatic pancreatic cancer * More than 2 months since prior adjuvant or neoadjuvant chemoradiotherapy for resected pancreatic cancer * Must have radiographic evidence of recurrent disease * More than 2 months since prior chemoradiotherapy for locally advanced pancreatic cancer * Must have radiographic evidence of disease progression * See Chemotherapy * See Chemotherapy * No other concurrent investigational or commercial agents or therapies for the malignancy * No other concurrent anticancer therapy * No concurrent combination antiretroviral therapy for HIV-positive patients

Study Objectives Determine if ICG administered pre-operatively, then imaged intraoperatively using our cameras, will aid in the identification of a suspected thoracic nodules, margins, lymph nodes and satellite nodules during minimally invasive procedures. The investigators intend on enrolling 48 Subjects in this study. The study is focusing on patients presenting with suspected thoracic cancers who are considered to be good minimally invasive surgical candidates Conditions: Neoplasms Intervention / Treatment: DRUG: Indocyanine Green Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Adult patients over 18 years of age * Patients presenting with a thoracic nodule presumed to be resectable cancer on pre-operative assessment * Good minimally invasive operative candidates as determined by a thoracic oncology multidisciplinary team * Subject capable of giving informed consent and participating in the process of consent. Exclusion Criteria: * Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery * Subjects with a history of iodide allergies * At-risk patient populations 1. Homeless patients 2. Patients with drug or alcohol dependence 3. Children and neonates 4. Patients unable to participate in the consent process

Study Objectives Objectives: To investigate the outcomes of fenestration decompression combined with secondary curettage (FDSC) in the surgical treatment of jaw ameloblastoma. Methods: Medical records of patients diagnosed as multicystic ameloblastoma (MA) or unicystic ameloblastoma (UA) by routine pathology were collected from January 2010 to December 2017 in Ninth People's Hospital, Shanghai JiaoTong University Medical College. Patients were divided into two groups based on the management regimen: FDSC group, and local curettage (LC) group. Patients were followed up for 3-8 years, using panoramic radiography to measure the change of the area of the cystic cavity involved in ameloblastoma and the recurrence or malignant transformation of the tumor in both groups. A total of 233 eligible patients were selected for provisional screening, including 145 patients with MA, and 88 patients with UA. Conditions: Cystic Cavity Area Reduction Efficiency, the Recurrence of the Tumor Intervention / Treatment: PROCEDURE: fenestration decompression combined with secondary curettage Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: *Medical records of patients who were diagnosed with multicystic ameloblastoma (MA) or unicystic ameloblastoma (UA) by routine pathology were collected from January 2010 to December 2017 in Ninth People's Hospital of Shanghai JiaoTong University Medical College. Exclusion Criteria: * followed up less than 3 years * For FDSC group, fenestration decompression failed * recurrent ameloblastoma * received other type of surgery;

Study Objectives Outcome of acute promyelocytic leukemia (APL) has greatly improved since the introduction of all-trans-retinoic acid (ATRA). Treatment with ATRA and anthracycline-based chemotherapy (ATRA + chemotherapy) decreases relapses of the disease as well as early hemorrhagic deaths. Nowadays patients with APL have an event-free survival (EFS) of up to 80%. However, there remains a subset of the patients in whom the disease relapses. Recently, a randomized prospective study showed that the addition of ATO to "ATRA + chemotherapy" treatment protocol had a significantly higher EFS in patients with APL than those treated with "ATRA + chemotherapy" protocol. The patients treated with "ATO + ATRA + chemotherapy" had a five years EFS of 89.2%. Moreover, a recent study showed that Indigo naturalis formula (RIF), a traditional Chinese medicine with tetraarsenic tetrasulfide (As4S4), indirubin, and tanshinone IIA as major active ingredients, yielded synergy in the treatment of a murine APL model in vivo and in the induction of APL cell differentiation in vitro . It is about 20 years since RIF was used to treat ALP in China. Clinical studies showed that this agent was effective against APL. Compared to ATO, RIF is relatively inexpensive and can be taken orally, resulting in reducing the number of hospital days and the treatment cost. However, there is no report comparing treatment outcomes of "ATO + ATRA + chemotherapy" and "RIF + ATRA + chemotherapy" protocols in children with APL so far. For this purpose, therefore, investigators are going to conduct a multicenter and randomized prospective study in children with APL. Conditions: Childhood Acute Promyelocytic Leukemia Intervention / Treatment: DRUG: ATO, DRUG: RIF, DRUG: ATRA, DRUG: mitoxantrone, DRUG: Ara-C, DRUG: MTX, DRUG: 6MP, OTHER: intrathecal injection Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients less than 16 years old with newly diagnosed PML-RARa positive acute promyelocytic leukemia. Exclusion Criteria: * Patients who have coma, convulsion or paralysis due to intracranial hemorrhage or central nervous system leukemia at diagnosis.

Study Objectives Irradiation and Accelerated Partial Breast (IPAS) to this day remains a therapeutic concept whose validity is being assessed on its non-inferiority in terms of local control compared to whole breast irradiation. At least eight phase III trials attempting to answer this question and thus provide a sufficient level of evidence to make this concept a new standard of care for sub-groups of patients well defined (1). However, without waiting for the final results of these randomized trials (which will not be fully valid with a drop of at least ten years), the American societies (ASTRO) and European (ESTRO) radiotherapy have all two proposed classification (very similar) into 3 groups according to the risk to the patient in terms of local recurrence after IPAS. And are defined by the ESTRO: * The low-risk group ("suitable" for ASTRO) * The intermediate-risk group ("cautionary" in ASTRO) * The high-risk group ("not suitable" for ASTRO) (2.3). Therefore, it is possible to propose to a patient a randomized clinical tria IPAS, to subject it belongs to the group "low risk." The results of phase II trials as a long-term analysis of the matched team of William Beaumont Hospital (4) and the phase III trial using intra-operative radiation photons in low energy X whose results were recently published (5) confirm the value of this new therapeutic concept for post-operative breast cancer at low risk of local recurrence. In France, the therapists were quickly directed to a sub-population for which the IPAS could represent a real improvement in the therapeutic management in significantly reducing the number of irradiation sessions of thirty in 6 weeks 5 days at 10 in a single view (6). Several French phase II trials were started specifically targeting the female population aged using a balloon catheter (MammoSite ®) (7) or by intra-operative radiation électronthérapie (8). The results of the test using the GERICO-03 brachytherapy with high dose rate (promoter: FNCLCC, National Federation of Anti Cancer Centres , recently merged into Group Health Cooperation entitled UNICANCER) are currently submitted to Journal Green Radiotherapy (Radiotherapy and Oncology from 09/11/11) (9). On a technical level, two main approaches are used (10): * Irradiation intraoperative electron or low-energy photons, * Radiation after surgery The advantage of intraoperative irradiation is the optimal reduction of total processing time radio-surgery because the patient is irradiated during the lumpectomy. However, 15-20% of these patients receive partial breast irradiation, as histo-prognostic criteria provided in the histologically final report, confirm the non-adapted indication of IPAS (5). In contrast, the post-operative IPAS can treat only patients meeting all criteria for IPAS but treatment-related travel are about 5 treatments for bi-fractionated (2 sessions per days separated by at least 6 hours). Conditions: Breast Cancer Intervention / Treatment: RADIATION: IPAS Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patient WITHinvasive breast cancer histologically proved: ductal, lobular, medullary, papillary, tubular or colloid: * All grades histo-prognostic * pT1 tumor size (<20 mm), * healthy Margins surgical * unifocal lesion * Any hormone receptor, * Any Her2 status, * No lymph node (sentinel lymphadenectomy or) or micrometastases (pN0, pN1mic) * Age greater than or equal to 70 years * Score Balducci I or II, * Karnofsky index greater than or equal to 70% * Time between lumpectomy and radiation less than 2 weeks * Implementation of clips in the tumor bed intraoperatively, * Patient having taken note of the information note and who signed the informed consent * Patient receiving social security coverage. Exclusion Criteria: * Lobular carcinoma in situ or pure ductal carcinoma in situ or non-epithelial tumor type sarcoma or lymphoma, * Component extensive ductal in situ associated * Peritumoral lymphatic emboli, * Distance Metastasis * Inflammatory Breast Cancer, * Multifocal tumor (covering a total distance inter-end of 40 mm or more) * Previous treatment for this tumor including breast radiotherapy and / or chemotherapy neoadjuvant or adjuvant * History of plastic surgery breast * Unknown or safety margins positive for invasive carcinoma * Absence of clips in the tumor bed, * Time between lumpectomy and radiation greater than or equal to 2 weeks * Active infection or other serious comorbidity that could prevent the patient receiving the treatment, * History of cancer other than a basal cell skin or carcinoma in situ of the cervix or other cancer in complete remission for more than 5 years * Psychiatric illness

Study Objectives Many studies have shown that inflammation has an important effect on the development, progression, and also response to treatment of tumors. Dexmedetomidine is a potent and selective alpha 2 receptor agonist, known to have a sedative, analgesic and immune-controlling effect. The purpose of this study is to investigate the effect of dexmedetomidine during surgery on postoperative inflammatory response and surgical recovery in gastric cancer patients undergoing robot or laparoscopic gastrectomy. Conditions: Gastric Cancer, Gastrostomy Intervention / Treatment: DRUG: dexmedetomidine, DRUG: saline Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * 1. 20-70 yrs old patients * 2. Scheduled for robot or laparoscopic gastrectomy * 3. Body weight under 90kg and BMI under 32 Exclusion Criteria: * 1. Emergency operation * 2. Reoperation * 3. Co-operation with other surgery department * 4. Co-operation with other organs (except cholecystectomy) * 5. Patients with history of heart failure (unstable angina, congestive heart failure) * 6. Patients with history of arrhythmia (specially AV nodal block), ventricular conduction problem * 7. Patients with history of uncontrolled hypertension (diastolic BP >110mmHg), extremely bradycardia (HR <45 bpm on ECG) * 8. Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia * 9. Patients who is steroid user * 10. Patients who is beta blocker user * 11. Patients with history of liver failure, renal failure, allergic to medicine * 12. Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression) * 13. Patients who cannot read the consent form (examples: Illiterate, foreigner) * 14. Patients who withdraw the consent

Study Objectives This is an in vitro evaluation of cutaneous T-cell lymphoma using patients' blood and tissue to evaluate immune responses related to identified tumor populations and dendritic/CD 8 cells. Conditions: Cutaneous T-cell Lymphoma, Sezary Syndrome, Mycosis Fungoides Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Males or females <18 years of age * Histologically confirmed stage IV cutaneous T-cell lymphoma, with at least 5% of the peripheral blood lymphocytes showing atypical morphology consistent with Sezary cells * Ambulatory and be in stable medical condition * Biopsy positive mycosis fungoides/CTCL or clonal type of CTCL as determined by PCR for TCR and Southern blot for TCR Exclusion Criteria: * Received any chemotherapy or radiotherapy within 4 weeks prior to enrollment * Significant psychiatric illness which would prevent adequate informed consent in the opinion of the principal investigator * Systemic steroid therapy other than maintenance for adrenal suppression * Known coagulopathy for non SS subjects.

Study Objectives Recently, HDR brachytherapy delivering only a 19 Gy fraction was proposed as exclusive treatment for low and intermediate risk prostate cancers. With a median 3-year follow-up, the Spanish team reported a biochemical control rate of 100% and 87%, respectively, for low risk and intermediate risk tumors. In parallel with these encouraging results regarding biochemical control, the authors described excellent urinary and digestive tolerance, notably the absence of grade \> 2 complications. However, it should be noted, in this study, that special protection was provided to the anterior aspect of the rectum by means of a 10 ml transperineal injection of hyaluronic acid into the prostate-rectal interspace. The idea of using a single high dose (in one fraction) was proposed at the MSKCC by the team of Fucks et al. which, in 2008, following a median 18-month follow-up, published a a 90% local control rate for spinal metastases after a single dose at 18 to 24 Gy. The aim of the present study is to analyze acute urinary and digestive toxicity (\< 180 days) observed following interstitial high dose rate prostate brachytherapy delivering a total dose of 20 Gy in one fraction. Conditions: Prostate Cancer Intervention / Treatment: RADIATION: exclusive single-fraction irradiation Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients suffering from histologically-proven adenocarcinoma-type prostate cancer: * with low risk of biochemical recurrence * with a low intermediate risk of biochemical recurrence (maximum of 1 intermediate risk factor)\* * stage T1c, T2a, T2b * Gleason score 6 (3+3) or 7 (3+4) with at most 3 positive biopsies * PSA < 15 ng/ml * Age ≥ 18 years * Karnofsky index ≥ 70% * Life expectancy ≥ 10 years * No contraindication to injection of hyaluronic acid in the prostate-rectal interspace * Patient aware of the information leaflet and having signed the informed consent form * Patient covered by medical insurance Exclusion Criteria: * Stage ≥ T2c * Gleason score 7 (4+3) or ≥ 8 * PSA > 15 ng/ml * Presence of the following anatomico-pathological criteria: * Involvement of the nerve fibers * Peri-tumoral vascular embolisms * Capsule involvement * Number of positive biopsies ≥ 50% * 100% positive biopsies in a lobe * Involvement of the seminal vesicle * Prostate volume ≥60 cc * Large prostatic transurethral resection and/or dating from less than 6 months * Poor urinary function in the absence of alpha-blockers * IPSS score > 15 * Post-mictional residue > 50 cc * Flow rate with Qmax < 12 ml/s * Remote metastasis * Neoadjuvant anti-androgenic treatment * Prior treatment with pelvic irradiation and/or chemotherapy * Active infection or other underlying severe pathology likely to prevent the patient from receiving treatment * History of cancer other than basocellular cutaneous cancer or other form of cancer in complete remission for more than 5 years * Evolving psychiatric disorder * Vulnerable persons as defined by article L1121-5 to -8

Study Objectives Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogneic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells. This is a multi-center, open-label, Phase I/II study of obatoclax administered in combination with docetaxel in 3-week cycles to patients with relapsed or refractory Non-Small Cell Lung Cancer. Treatment may be administered on an outpatient basis. No investigation or commercial agents or therapies other than those described herein may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Non-Small Cell Lung Cancer are allowed. Conditions: Lung Cancer Intervention / Treatment: DRUG: Obatoclax mesylate 250 ml, DRUG: Docetaxel 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: * Pathological confirmation of Non-Small Cell Lung Cancer (NSCLC) * Must have been previously treated with a single platinum-based chemotherapy regimen and shown evidence of disease progression; no further limitations * Must have normal organ function * Must be willing to submit to blood sampling for planned PK and PD analysis * Must have the ability to understand and willingness to sign a written informed consent form Exclusion Criteria: * No other agents or therapies administered with the intent to treat malignancy * Patients with prior exposure to obatoclax or docetaxel * Uncontrolled, intercurrent illness * Pregnant women and women who are breast feeding

Study Objectives The oncologic benefit of lateral neck dissection (LND) during index operation for sporadic medullary thyroid carcinoma (MTC) basing on basal calcitonin (bCT) levels has been questioned due to the potential post-operative complications. This study aims to evaluate desmoplastic reaction (DSR), as predictor of nodal metastases, for definition of surgical strategy. Data from pathological report of MTC after operations between 1997 and 2022 were collected. The primary endpoint of the study was evaluating the risk factors for nodal metastases. The secondary endpoints analyzed the correlations between DSR and nodal metastases and the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of DSR for nodal metastases. Conditions: Medullary Thyroid Cancer, Medullary Carcinoma, Medullary Tumor, Medullary Neoplasms, Desmoplasia, Desmoplastic, Desmoplastic Reaction, Lymph Node Metastasis, Lymph Node Disease Location: Italy Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * All adults patients who underwent index procedure for sporadic unifocal MTC whose specimens were retrospectively re-evaluated by an expert endocrine pathologist (E.D.R.) for DSR were candidates for inclusion. Exclusion Criteria: * hereditary MTC * sporadic multifocal MTC * index operation in another center * incidental diagnosis of MCT after less than total thyroidectomy and bilateral central neck dissection * less than 6-months-follow-up * patients < 18 years old

Study Objectives This study aims to compare the efficacy and tolerance of a new photodynamic therapy device (PHOS-ISTOS) with the conventional PDT device (Aktilite®) for the treatment of actinic keratosis of the scalp Conditions: Keratosis, Actinic Intervention / Treatment: DEVICE: Aktilite® Galderma, DEVICE: PHOS ISTOS PDT Location: Germany, France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Clinical diagnosis of minimum 10 previously untreated not pigmented, non-hyperkeratotic AK lesions of Grade I and II of the forehead and/or scalp (according to Olsen et Al. JAAD 1991, cf. REF 31) where other therapies are unacceptable or considered medically less appropriate with a symmetrical repartition on both side of the forehead and/or scalp. The diagnosis of AK will be determined upon clinical evaluation (i.e. visual inspection and palpation) by the investigator. * No treatment for the AKs in the previous 30 days. * Symmetrical areas in terms of number and severity of lesions. The axis of symmetry between the two areas will be defined by the investigator according to the distribution of lesions. * The two areas to be treated should not be coalescing. A minimum distance of 10 mm is required between the lesions located on the 2 symmetrical areas. A minimum distance of 2 mm is required between the lesions on the same side. * Minimum 5 lesions with similar dimensions at both symmetrical areas will be treated. If the number of lesions is >7, only 7 lesions on each side will be considered. Exclusion Criteria: * Patients with porphyria. * Patients immunosuppressed for idiopathic, disease specific or therapeutic reasons. * Use of topical corticosteroids to lesional areas within 2 weeks before PDT. * Patients receiving local treatment (including cryotherapy and curettage-electrocoagulation, any PDT treatment) in face / scalp area within the last 30 days. * Patients receiving topical treatment (including imiquimod, 5-FU and diclofenac, Picato) in face / scalp area within the last 30 days.in * Use of topical retinoids or alpha-hydroxy acids, systemic retinoids, chemotherapy or immunotherapy within 30 days of PDT. * Pigmented AK lesion(s). * Known allergy to Metvixia/Metvix, a similar PDT compound or excipients of the cream including arachis oil, or to peanut or soya. * Participation in other clinical studies either currently or within the last 30 days. * Female subjects must be of either: * Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or, * Childbearing potential, provided there is a confirmed negative urine pregnancy test or blood analysis prior to study treatment, to rule out pregnancy. * Any condition which may be associated with a risk of poor protocol compliance. * Patients currently receiving regular ultraviolet radiation therapy.

Study Objectives The main objective of this study is to describe the evolution in quality of life (QLQ-C30) for patients receiving breast cancer care at 3, 6 and 12 months after a "remission" consultation. Conditions: Breast Neoplasms Intervention / Treatment: OTHER: Remission Consultation Location: France Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * The patient is receiving care for localized breast cancer and finished her adjuvant treatment (chemotherapy, radiotherapy) * The patient has completed his/her adjuvant therapy in the last 6 months (chemotherapy, radiotherapy). Exclusion Criteria: * The patient is participating in another study * The patient is under judicial protection * It is impossible to correctly inform the patient * The patient has a metastatic form of the disease at diagnosis

Study Objectives The present study aims at investigating the feasibility, the detection rate and the negative predictive value of sentinel node in predicting the presence or absence of lymph node metastasis in ovarian cancer patients Conditions: Sentinel Lymph Node, Ovarian Cancer Stage I Intervention / Treatment: PROCEDURE: Sentinel node detection Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Epithelial ovarian cancer * Early stage disease limited to the ovary Exclusion Criteria: * Evidence of extraovarian disease * Allergy to the materials used

Study Objectives This randomized phase I/II trial studies the side effects and best dose of rintatolimod when given together with vaccine therapy and sargramostim (GM-CSF) to see how well it works in treating patients with stage II-IV human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Vaccines made from synthetic HER2/neu peptides may help the body build an effective immune response to kill tumor cells that express HER-2/neu. Adjuvant therapies, such as GM-CSF and rintatolimod, are additional cancer treatments given after the primary treatment to lower the risk that the cancer will come back and are one way to help vaccines produce stronger immune responses. Giving vaccine therapy together with rintatolimod and/or GM-CSF may be a safe and effective treatment for breast cancer. Conditions: HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer Intervention / Treatment: BIOLOGICAL: HER-2/neu peptide vaccine, BIOLOGICAL: sargramostim, DRUG: rintatolimod Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Patients with stage II, or III HER2+ breast cancer who have completed definitive standard treatment and are in complete remission - or - * Patients with stage IV HER2+ breast cancer treated to: * No evidence of disease, or * Stable bone only disease after definitive therapy * Patients must have demonstrated HER2 positive disease, by one of the following methods: * Immunohistochemical (IHC) staining of 1+, 2+ or 3+ for the HER2 protein, or * Amplification of the HER2 gene on fluorescence in situ hybridization (FISH) * Patients must be at least 14 days post cytotoxic chemotherapy prior to enrollment * Patients must be at least 14 days post systemic steroids prior to enrollment * Patients on bisphosphonates or continued hormone therapy are eligible * Men and women of reproductive ability must agree to contraceptive use during the entire study period * Patients must have Zubrod Performance Status Score of =< 2 * Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment * White blood cell count (WBC) >= 3000/mm\^3 * Hemoglobin (Hgb) >= 10 mg/dl * Serum creatinine =< 2.0 mg/dl or creatinine clearance > 60 ml/min * Total bilirubin =< 1.5 mg/dl * Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 times the upper limit of normal * Patients on trastuzumab monotherapy must have adequate cardiac function as demonstrated by normal ejection fractions (EF) on multi gated acquisition scan (MUGA) scan or echocardiogram performed within the last 3 months of eligibility sign off Exclusion Criteria: * Restrictive cardiomyopathy * Unstable angina within 6 months prior to enrollment * New York Heart Association functional class III-IV heart failure * Symptomatic pericardial effusion * Patients with any contraindication to receiving rhuGM-CSF based products * Patients with any clinically significant autoimmune disease requiring active treatment * Patients receiving any concurrent immunomodulators within 30 days of eligibility sign-off * Patients who are pregnant or breast-feeding * Patients who are simultaneously enrolled in any other treatment study * Patients who have received a previous HER2 breast cancer vaccine

Study Objectives Appropriate patients undergoing going immediate breast reconstruction with tissue expanders following mastectomy will be randomized to receive one-port or two-ports tissue expanders. Their clinical course, complications, and outcome will be analyzed. Conditions: Breast Cancer Intervention / Treatment: DEVICE: Allergen one-port tissue expander placement, DEVICE: AlloX2 two-port tissue expander placement Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * patient agrees to immediate tissue expander breast reconstruction * a suitable patient for tissue expander reconstruction Exclusion Criteria: * not a surgical candidate for immediate breast reconstruction * age less than 18 * patient declines tissue expander reconstruction * patient anticipated to need radiation therapy postoperatively

Study Objectives The primary purpose of this study is to determine the feasibility and tolerability of a regimen of accelerated (hypofractionated) Intensity Modulated Radiation Therapy (AIMRT) to the whole breast as part of breast preservation. In addition, the investigators want to prospectively collect blood specimens to: assess TGF-β polymorphisms to identify potential carriers at higher risk for post-treatment fibrosis; generate a blood specimen repository for future studies of other relevant polymorphisms. The study investigators also want to prospectively follow each treated woman yearly to assess long-term radiation sequelae of the current regimen by using the LENT/SOMA scores. Conditions: Breast Cancer Intervention / Treatment: RADIATION: Accelerated intensity modulated radiation therapy (AIMRT) 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: * Pre- or post-menopausal women with Stage I and II breast cancer * Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm * Status post segmental mastectomy. and after sentinel node biopsy and/or axillary node dissection * At least 2 weeks from last chemotherapy * Tumors < 5 mm do not require nodal assessment Exclusion Criteria: * Previous radiation therapy to the ipsilateral breast. * More than 3 involved nodes identified at axillary staging, requiring adjuvant axillary radiation. * Active connective tissue disorders, such as lupus or scleroderma. * Prior or concurrent malignancy other than basal or squamous cell skin cancer or carcinoma in-situ of the cervix, unless disease-free > 5 years. * Pregnant or lactating women.

Study Objectives The goal of this clinical research study is to evaluate an experimental imaging technology, the multispectral digital microscope (MDM), which may help doctors see how far skin cancer extends (widens out) on an area of skin. Researchers want to learn if this new technology can help doctors identify the exact areas involved in precancerous or cancerous changes in the skin. Conditions: Skin Cancer Intervention / Treatment: PROCEDURE: Optical Imaging Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients who will be undergoing surgery to remove a region of skin suspected of containing non-melanoma skin cancer will be eligible to participate in this study. The proposed resection should be equal or greater than 1 cm in diameter. * In addition, patients undergoing induction chemotherapy or biologic therapy prior to surgical resection are also eligible. * Patients must sign an informed consent indicating awareness of the investigational nature of this study. Exclusion Criteria: * Patients with non-melanoma skin cancer lesion at eyelid, or in case that the lesion extends to superior or inferior eyelid, this area will not be imaged. * Persons who are medically unfit to undergo resection of skin lesions. * Persons under the age of 18.

Study Objectives The goal of this clinical research study is to find out if Xeloda® (capecitabine) and radiation therapy can help to control breast cancer that did not respond well to chemotherapy. The safety of this study treatment will also be studied. Conditions: Breast Cancer Intervention / Treatment: RADIATION: Radiation Therapy, 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: * Histological confirmation of invasive breast cancer * No contraindications to receiving a course of radiation treatment (pregnancy, prior radiation to the volume with disease, or systemic disease in which radiation therapy is an absolute contraindication) * Patients who have chemo-refractory gross disease in the breast causing symptoms (pain, drainage, duress) OR gross disease in the breast (greater than or equal to T3) and/or lymph node(s) progressive, persistent, or minimally responsive to chemotherapy deemed inoperable or questionable inoperable OR Recurrent gross disease in a previously unirradiated breast or on the chest wall or in the regional lymphatics (core biopsy will not be offered to patients without gross disease in the breast). * Are able to swallow and retain oral medication (intact pill) * Age over 18 * Female gender Exclusion Criteria: * Have an active or uncontrolled infection * Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent * Have used an investigational drug within 21 days preceding the first dose of study medication * Are receiving therapeutic anti-coagulation therapy (i.e. warfarin, heparin) * Uncontrolled arrhythmia or congestive heart failure (CHF) based on clinical history or physical exam * Patient cannot receive whole brain irradiation concurrently with Xeloda treatment.

Study Objectives Sun Safe Workplaces (SSW), a comprehensive occupational sun safety program, promoted education and policy to 98 cities, counties, and special districts in Colorado. In a two-year follow-up study, Klein Buendel, Inc. (KB) proposes to examine the effectiveness of SSW on employee sun protection practices by employers and return on investment in an economic evaluation of the cost of the SSW intervention. The results of this follow-up study will provide critical information on effective approaches to increasing sun protection across a wide range of employment sectors with outdoor workers. Conditions: Skin Cancer Intervention / Treatment: BEHAVIORAL: Sun Safe Workplaces Program, BEHAVIORAL: Attention Control Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Participation in the prior Sun Safe Workplaces: A Campaign on Sun Protection Policies for Outdoor Workers. * A local government organization with employees who worked outdoors in at least one of the following service areas: public works, public safety, and parks and recreation, * Having a full time executive * Having a population of at least 3000 residents * Being employed at a participating local government organization as a manager or employee? * Being employed at a participating local government organization in a job requiring outdoor work at least part of the time. Exclusion Criteria: * Organization had participated in the authors' previous occupational sun protection project.

Study Objectives In this study, the investigators will enroll women with palpable cancers to assess the accuracy of the Breast Cancer Locator (BCL) and the concomitant procedure as a vehicle to optimize and validate the approach in such surgical cases. This approach of adopting palpable cancer patients before initiating an evaluative trial of the BCL in non-palpable breast cancer cases ensures that the BCL does not substantially alter or modify the standard-of-care procedure. Conditions: Breast Cancer Intervention / Treatment: DEVICE: Breast Cancer Locator (BCL) 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: * Age greater than or equal to 18 years * Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ * Patient desire to undergo breast surgery * Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted * The cancer enhances on breast MRI imaging. Exclusion Criteria: * Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes * Severe claustrophobia * Contraindication to use of gadolinium-based intravenous contrast, including life-threatening allergy or compromised renal function (creatinine > 2.0) * History of median sternotomy * Pregnancy. Patient attestation that they are not pregnant will be acceptable as per standard policy for MRIs at DHMC.

Study Objectives The main purpose of the study is to investigate the safety and tolerability of AZD3514 when given orally to patients with castration-resistant prostate cancer (CRPC) Conditions: Prostate Cancer Intervention / Treatment: DRUG: AZD3514 Location: Netherlands, United Kingdom, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Males aged 20 years or older. * Histologically or Cytologically proven diagnosis of prostate cancer for which no standard therapy is currently considered appropriate. * Documented evidence of metastatic prostate cancer * Presence of progressive disease defined as one or more: * Biochemical progression of the prostate cancer * Progression as defined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 guidelines * Two or more new metastatic bone lesions from bone scans from a previous assessment * Serum testosterone concentration less or equals 50 ng/dL * World Health Organization (WHO) performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks. * Sexually active males should be willing to use condoms * For inclusion in the AZD3514 administered in combination with abiraterone acetate cohort(s), patients must: * Have received prior chemotherapy containing or based on docetaxel * Not have received prior treatment with abiraterone acetate, MDV3100, TAK700, TOK001 or other similar therapies which target the AR axis or with selective AR down-regulator-like properties * For inclusion in the AZD3514 administered in combination with abiraterone acetate in patients who are currently receiving abiraterone acetate cohort(s), patients must: 1. Have been stable on abiraterone acetate abiraterone acetate for ≥ 4 months (i.e. stable PSA values) and have achieved ≥ 50% reduction in PSA while being treated with abiraterone acetate 2. Have evidence of biochemical progression (PSA) of the prostate cancer, as defined in inclusion number 5 (except for the withdrawal of abiraterone acetate as an anti-androgen therapy) * For inclusion in the paired (same lesion) tumour biopsy research, patients must: 1. Provide informed consent for paired tumour biopsy sampling 2. Have bone or soft tissue lesions that are suitable for paired biopsy sampling Exclusion Criteria: * Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAEv4) grade 1 except for alopecia or toxicities related to the use of gonadotropin-releasing hormone agonists * Medically important spinal cord compression or brain metastases * Medically important evidence of severe or uncontrolled systemic disease * History of hypersensitivity to active or inactive excipients of AZD3514 or drugs with a similar chemical structure or class to AZD3514 * Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD3514 * Inadequate bone marrow reserve or organ function * Any medically important factors identified from electrocardiogram (ECG) measurements * Concurrent or recent treatment with certain medications or medical procedures The following criteria exclude patients from entering the AZD3514 administered in combination with abiraterone acetate cohort(s): * As judged by the investigator, any evidence of severe or uncontrolled systemic diseases or conditions, including adrenocortical insufficiency or a history of cardiovascular disease including heart failure (currently there are no randomized data for the use of abiraterone acetate in patients with LVEF < 50% or NYHA Class III or IV heart failure), which would make it undesirable for the patient to participate in the trial. See the full local prescribing information for abiraterone acetate for more detail * Child-Pugh class B and C hepatic impairment * If unable to fast for ≥ 2 hours prior to taking a dose to ≥ 1 hour post dose * Received abiraterone acetate treatment previously * Known hypersensitivity to components of prednisone or prednisolone * Any systemic fungal infections

Study Objectives Very few papers examine the effect of living at high altitudes on surgical results of major operations. This research is designed to determine the surgical outcomes of PD for periampullary tumour in high altitudes and normal altitudes. Conditions: Periampullary Cancer Intervention / Treatment: PROCEDURE: PANCREATICODUDENECTOMY Location: Egypt Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * periampulary tumour Exclusion Criteria: * liver cirrhosis, * PG, * advanced tumour, * vascular resection

Study Objectives This phase I/II trial is studying the side effects and best dose of viral therapy in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that did not respond to platinum chemotherapy (phase II closed as of 1/7/2011). Viral therapy may be able to kill tumor cells without damaging normal cells. Conditions: Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma Intervention / Treatment: OTHER: Laboratory Biomarker Analysis, BIOLOGICAL: Wild-type Reovirus 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: * Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer * Recurrent disease after platinum-based chemotherapy * Must have experienced disease persistence during primary platinum-based therapy or recurrence within 12 months after completion of platinum-based chemotherapy ("platinum-refractory" or "platinum-resistant" disease) * A patient receiving a second course of platinum-based chemotherapy for platinum-sensitive disease who then develops persistence or recurrence within 12 months is considered eligible for this trial * Must have measurable disease by RECIST criteria (phase II) (phase II closed as of 1/7/2011) * Must have received ≥ 1 prior platinum-based cytotoxic chemotherapy regimen (for primary disease) containing carboplatin, cisplatin, or other organoplatinum compound * Initial treatment may have included any of the following: * High-dose therapy * Consolidation therapy * Intraperitoneal (IP) therapy * Extended therapy administered after surgical or nonsurgical assessment * One additional non-cytotoxic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors) for recurrent or persistent disease allowed * Patients may have received hormonal therapy for management of disease (e.g., SERMs, aromatase inhibitors, progestins, and GnRH agonists) * No loculated ascites for which IP distribution of virus is not expected to be feasible * No known brain metastases * GOG performance status (PS) 0-2 (Karnofsky PS 60-100%) * Life expectancy > 12 weeks * Leukocytes ≥ 3,000/mcL * Absolute neutrophil count ≥ 1,500/mcL * Hemoglobin ≥ 10 g/dL * Platelets ≥ 100,000/mcL * Total bilirubin normal * AST/ALT ≤ 2.5 times upper limit of normal * Creatinine normal * Ejection fraction > 50% by echocardiogram or MUGA * Cardiac enzymes normal * Not pregnant or nursing * Fertile patients must use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation * Must be able to avoid direct contact with pregnant or nursing women, infants, or immunocompromised individuals while on study and for ≥ 3 weeks following the last dose of study agent administration * Cardiac conduction abnormalities (e.g., bundle branch block, heart block) are allowed if their cardiac status has been stable for 6 months before study entry * At least 4 weeks since most recent cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin C) * Recovered from adverse events due to agents administered more than 4 weeks earlier * No prior radiotherapy to the abdomen or pelvis * No other concurrent investigational agents * No investigational or commercial agents or therapies other than those described below may be administered with the intent to treat the patient's malignancy Exclusion Criteria: * Patients in whom insertion of an IP catheter is not feasible due to surgical contraindications or abdominal and pelvic adhesions * Known HIV infection or hepatitis B or C * Clinically significant cardiac disease (New York Heart Association class III or IV cardiac disease) including any of the following: * Pre-existing arrhythmia * Uncontrolled angina pectoris * Myocardial infarction 1 year prior to study entry * Compromised left ventricular ejection fraction ≥ grade 2 by MUGA or echocardiogram * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements * Chronic oral steroids at an equivalent dose of prednisone 5 mg daily * Inhaled steroids allowed * Patients on immunosuppressive therapy * Concurrent routine prophylactic use of growth factor (filgrastim \[G-CSF\] or sargramostim \[GM-CSF\])

Study Objectives This study is a Phase I study using vinblastine and sirolimus in patients with relapsed solid tumors including selected brain tumors and lymphoma. The investigators hypothesis is that the combination administration of weekly vinblastine and sirolimus is safe. Conditions: Solid Tumors, Central Nervous System Tumors Intervention / Treatment: DRUG: Vinblastine and Sirolimus Location: Canada, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age: 0-21 years at the time of diagnosis * Diagnosis: Histologic verification at either the time of original diagnosis or relapse of solid tumor including CNS tumors or lymphomas * Disease Status: All refractory/recurrent solid tumors including CNS tumors (all Diffuse Intrinsic Brain Stem Gliomas excluded) and lymphomas that have relapsed after, or are refractory to, a chemotherapy-containing treatment regimen * Measurable disease: * Measurable tumor by CT or MRI defined as >10 mm by spiral CT in at least one dimension * Current disease state must be one for which there is currently no known curative therapy * A negative urine pregnancy test is required for female participants of child bearing potential * Organ Function Requirements: * adequate liver function as defined by AST or ALT < 5 x upper limit of normal, bilirubin ≤1.5 X upper limit of normal * adequate renal function: Serum creatinine < 1.5 X upper limit of normal for age * Adequate Bone Marrow Function Defined as: * ANC ≥ 1000/mm3, platelets ≥ 75,000/mm3 and hemoglobin ≥ 90 g/L * Transfusions are permitted to meet these platelet and Hgb criteria, if the patient is known to have a history of bone marrow involvement with tumor * Patients with platelet counts < 75,000/ mm3 who are refractory to platelet transfusions are not eligible for this study * Patients requiring transfusions of platelets or RBC to meet eligibility criteria will not be evaluable for platelet or hgb/hct hematological toxicity * Lansky Play Score (for patients < 16 years of age) must be more than 50 and/or ECOG performance status (for patients ≥ 16 years of age) must be 0 to 2 * Specific requirements for Neuroblastoma patients Stratum: * MIBG scan with positive uptake at minimum of one site (MIBG not required if subject's neuroblastoma is previously determined to not uptake MIBG and no measurable disease) * Bone marrow with tumor cells seen on routine morphology (not by NSE staining only) of bilateral aspirate and /or biopsy on one bone marrow sample * Written informed consent Exclusion Criteria: * Lansky score <50% * Investigational Drugs: Patients who are currently receiving another investigational drug(s) * Previous treatment with Vinblastine and/or mTor inhibitors * Anti-cancer Agents: Patients who are currently receiving other anticancer agents. Patients must have fully recovered from the effects of prior chemotherapy, generally at least 3 weeks from the most recent administration (6 weeks for nitrosoureas) * Infection: Patients who have an uncontrolled infection are not eligible until the infection is judged to be well controlled * Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal * One week from usage of hematopoietic Growth Factor * Patients who are refractory to platelet transfusions * Brain Stem Glioma patients

Study Objectives Postmenarchal female cancer patients scheduled to undergo cancer therapy may enroll in this study to assess changes in existing and novel surrogate measures of fertility potential before, during and after chemotherapy. Measures of fertility potential to be tested include ultrasound imaging for antral follicle counts and ovarian volumes, endocrine evaluation, and assessment of oxidative stress. Conditions: Effects of Chemotherapy Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Females with the diagnosis of cancer schedules to be treated with chemotherapy and or radiation therapy. * Age between 15-45 years. * Post-menarchal. * Presence of a uterus and both ovaries. * Ability and willingness to comply with study protocol. * Have given written informed concent (or assent with parental consent in minors), prior to any study-related procedure, not part of normal medical care, with the understanding that consent may be withdrawn byt he patient at any time without prejudice to their future medical care. Exclusion Criteria: * Current pregnancy. * Lactation within the previous 3 months. * Any medical condition other than cancer, with in the judgment of the investigator is known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, adrenal dysfunction, Cushing's syndrome, hyperprolactinemia, and polycystic ovarian syndrome).

Study Objectives Objectives: Primary objective: * Phase-I: To determine the maximal tolerated dose (MTD) of panobinostat (LBH589) + Ifosfamide + Mesna, Carboplatin and Etoposide (ICE) combination * Randomized Phase-II: To estimate the complete response (CR) rate in patients with relapsed and refractory classical Hodgkins Lymphoma (HL) receiving ICE versus PANOBINOSTAT plus ICE therapy Secondary Objectives: * To assess the safety and tolerability of the novel combination of PANOBINOSTAT (LBH589) plus ICE versus ICE in patients with relapsed and refractory HL * To estimate the overall response rate (CR + partial response PR) * To estimate the success rate of stem cell collection in patients eligible for stem cell transplant * To estimate the percentage of patients who subsequently undergo autologous stem cell transplantation (ASCT) * To estimate the event free survival (EFS) at 1 year after randomization * To determine pretreatment expression level of histone deacetylases (HDAC1), HDAC2, and pSTAT3 and Signal transducer and activator of transcription protein (pSTAT6) by Immunohistochemistry (IHC) and correlate the results with treatment response Conditions: Hodgkin's Lymphoma Intervention / Treatment: DRUG: Panobinostat, DRUG: Ifosfamide, DRUG: Mesna, DRUG: Carboplatin, DRUG: Etoposide, DRUG: Pegfilgrastim Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed classical Hodgkin lymphoma (nodular sclerosis, mixed cellularity, or lymphocyte-rich classical HL). * Patients must have failed (relapsed or refractory) front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP. * Bidimensionally measurable disease with at least 1 lesion >= 2.0 cm in a single dimension * Acceptable hematologic status:Hemoglobin >= 9.0 g/dL, Absolute neutrophil count >= 1500 cells/mm3, Platelet count >= 100,000 cells/mm3 * Normal serum K+, Mg+, PO4, and total Ca++ (pre-treatment abnormal values may be therapeutically corrected before starting therapy and must be documented as normal or if abnormal values persist must be documented as clinically insignificant). Albumin should be >= 3 * Pre-study World Health Organization (WHO) performance status of 0, 1, or 2 * Age >= 16 years * Voluntary signed Institutional Review Board (IRB) approved consent informed before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. * Patients of reproductive potential (female of child bearing potential has not been postmenopausal for at least 12 consecutive months or not surgically sterile; male of child bearing potential has not been surgically sterile)must follow accepted birth control methods (e.g. barrier method) during treatment. * Clinically euthyroid. Note: Patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism. * Baseline Multiple Gated Acquisition (MUGA) or ECHO must demonstrate left ventricular ejection fraction (LVEF) >= 50%. Exclusion Criteria: * Lymphocyte predominant histology * More than one prior chemotherapy regimens. * Prior therapy with other HDAC inhibitors, including valproic acid * Prior therapy with heat shock protein (HSP)-90 inhibitors * Prior stem cell transplant * Abnormal liver function: Bilirubin > 2.0 mg/dL (26 µmol/L), Alkaline phosphatase > 2 x upper limits of normal (ULN), aspartate aminotransferase AST (SGOT) and/or alanine aminotransferase ALT > 2 x ULN * Serum creatinine >1.5 mg/dl * Presence of Central Nervous System (CNS) involvement with Hodgkin lymphoma * Presence of Human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS). * Another primary malignancy (other than squamous cell and basal cell carcinoma of the skin, in situ carcinoma of the cervix, or treated prostate cancer with a stable Prostate Specific Antigen PSA) for which the patient has not been disease free for at least 3 years. * Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions which would compromise protocol objectives in the opinion of the investigator * Impaired cardiac function or clinically significant cardiac diseases, including any one of the following:History or presence of sustained ventricular tachyarrhythmia, Any history of ventricular fibrillation or torsade de pointes, Bradycardia defined as HR< 50 bpm, Patients with pacemakers are eligible if HR >= 50 bpm, Screening ECG with a corrected QT interval (QTc) > 450 msec, Right bundle branch block + left anterior hemiblock (bifascicular block), Patients with myocardial infarction or unstable angina <= 6 months prior to starting study drug, Other clinically significant heart disease (e.g., congestive heart failure (CHF) New York Heart Association class III or IV , uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen) * Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum Beta-human chorionic gonadotropin (Beta-hCG) pregnancy test result obtained during screening, unless the female has recently (within 8 weeks) undergone egg harvest, which would result in the (Beta-hCG) test to be elevated without pregnancy. Pregnancy testing is not required for post-menopausal or surgically sterilized women. * Patient has received other investigational drugs within 14 days before enrollment or who have not recovered from side effects of those therapies. * Serious medical or psychiatric illness likely to interfere with participation in this clinical study. * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat * Patients with diarrhea > Common Terminology Criteria for Adverse Events Version 4 (CTCAE V.4) grade 2 * Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug. * Patients who have received either immunotherapy within <= 8 weeks; chemotherapy within <= 3 weeks; or radiation therapy to > 30% of marrow-bearing bone within <= 2 weeks prior to starting study treatment; or who have not yet recovered from side effects of such therapies. * Patients who have undergone major surgery <= 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy.

Study Objectives This study evaluated whether the addition of daily BKM120 to weekly paclitaxel was effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer. Conditions: Breast Cancer Intervention / Treatment: DRUG: Paclitaxel, DRUG: BKM120 matching placebo, DRUG: BKM120 Location: Japan, Israel, France, Taiwan, Hungary, United Kingdom, Italy, Germany, Brazil, Belgium, Austria, Australia, United States, Singapore, Canada, Spain, Czech Republic, South Africa, Russian Federation, Hong Kong, Netherlands, Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Breast cancer that is locally advanced or metastatic * HER2 negative disease, and a known hormone receptor status - ER/PgR (common breast cancer classification tests) * A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K activation status) before randomization * Adequate bone marrow and organ function * Measurable or non-measurable disease Exclusion Criteria: * Prior chemotherapy for locally advanced or metastatic disease * Previous treatment with PI3K or AKT inhibitors * Patient has symptomatic CNS metastases * Concurrent malignancy or malignancy within 3 years of study enrollment * Hematopoietic colony-stimulating growth factors or radiation within 2-4 weeks prior to starting study drug * Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent * Active heart (cardiac) disease as defined in the protocol * Known hypersensitivity or contraindications to use paclitaxel * Pregnant or nursing (lactating) woman * Certain scores on an anxiety and depression mood questionaire given at screening * Other protocol defined criteria may apply

Study Objectives Primary Objective: Participants achieving an Objective Response Rate Secondary Objective: * Progression Free Survival * Overall Survival * Response Duration * Safety Conditions: Diffuse Large B-cell Lymphoma Intervention / Treatment: DRUG: SAR3419 Location: Czechia, Spain, United States, Italy, Turkey, Israel, Poland, Belgium, United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion criteria: * Histological diagnosis of Diffuse Large B Cell Lymphoma (de novo or transformed) expressing CD19 by immunohistochemistry or flow cytometry analysis (>30% positivity), based on recent (less than 6 months) or new biopsy. * At least 1 prior specific therapeutic regimen, one of which should have included rituximab (patients previously eligible for transplantation: the salvage treatment followed by intensification and Autologous Stem Cell Transplant (ASCT) will be considered one regimen). * Relapsed disease after standard 1st line therapy for aggressive lymphoma - not eligible for high dose chemotherapy with stem cell support. Relapsed or refractory disease after two lines of therapy one of which could have included Autologous Stem Cell Transplant (ASCT). Relapsed disease is defined as progression after a disease free interval of at least 6 months after completion of last therapy. Refractory is defined as progression of disease during prior therapy or within 6 months from its completion. * Available paraffin-embedded tissue should have been collected no longer than 6 months prior to first administration of SAR3419. Cryo-preserved tissue cannot be used. If archival material is not available, a Fine Needle Aspiration (FNA) must be obtained. Exclusion criteria: * Primary refractory patients * Patients with primary mediastinal DLBCL The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Objectives Objective: To assess the effect of bevacizumab on tumor vessels, and the reversibility of the effect, using contrast-enhanced ultrasonography (CEUS) and histology in patients with metastatic liver tumors derived from colorectal cancer. Background Data: Direct evidence on the reversibility of any change in tumor vascularity upon bevacizumab cessation in the clinical setting is lacking. Methods: The study included 10 patients who received chemotherapy including bevacizumab, experienced a reduction in tumor vascularity as demonstrated by CEUS and consequently underwent liver resection. CEUS was performed before and immediately after 4 courses of chemotherapy and one day before surgery. The number of microvessels highlighted by anti-CD34 antibody in the viable tumor tissue was counted to quantify the microvessel density (MVD). As a control, 10 surgical specimens from 10 patients who had not received chemotherapy were examined. Conditions: Colorectal Cancer Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * patients who received chemotherapy (FOLFOX) including bevacizumab. The patients had an associated reduction in tumor vascularity as estimated by ultrasonography and consequently underwent surgical resection of the metastatic liver tumors for curative purposes. Exclusion Criteria: * none

Study Objectives The purpose of this study is to evaluate the efficacy in terms of the pathological complete response (pCR) rate and the efficacy to preoperative administration of Anthracycline-based regimen followed by Nab-paclitaxel and Trastuzumab in patients with HER2 positive operable breast cancer. Conditions: Breast Cancer, HER-2 Positive Breast Cancer, Effects of Chemotherapy Intervention / Treatment: DRUG: Nab-paclitaxel Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed invasive breast cancer * T1c-3 N0-2a * Confirmed of hormonal receptor status * HER2 positive confirmed by IHC 3+ or FISH+ * LVEF > 50% by echocardiogram or MUGA * Adequate EKG * No prior treatment for breast cancer * PS 0-1 * Required baseline laboratory data WBC > 4,000/mm3 and Neut > 2,000/mm3 PLT > 100,000/mm3 Hb > 9.0g/dl AST and ALT < ULNx2.5 T-Bil < 1.5mg/dl Serum creatinin < 1.5mg/dl * Written informed consent Exclusion Criteria: * With history of hypersensitivity reaction for important drug in this study * With history of invasive breast cancer * Bilateral invasive breast cancer * Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus * Positive for HBs antigen and with history of HVB * With history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension * With severe edema * With severe peripheral neuropathy * With severe psychiatric disorder * Pregnant or nursing women * Cases who physician judged improper to entry this trial

Study Objectives 85 percent of women of reproductive age experience consistent period cramps/menstrual pain, and 60% indicate that they do not use painkillers to relieve menstrual symptoms; there is a need for natural and non-medicative supplements to dysmenorrhea. The purpose of this clinical trial is to examine the effect of 'Cramp Bites'--classified by a mixture of natural ingredients researched to help with period pain--on women suffering from primary dysmenorrhea: this will be done through providing participants with the snack and surveying them on how it changes their period symptoms. Conditions: Dysmenorrhea Primary, Dysmenorrhea, Menstrual Discomfort, Menstrual Problem, Menstrual Cycle Abnormal, Menstrual Pain, Period Pain, Period Problem, PMS, Premenstrual Syndrome, PCOS, PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, PCOS (Polycystic Ovary Syndrome) of Left Ovary, PCOS (Polycystic Ovary Syndrome) of Right Ovary, Polycystic Ovary Syndrome, Premenstrual Dysphoric Disorder, Cramps, Ovarian Cysts Intervention / Treatment: DIETARY_SUPPLEMENT: Cramp Bites by Aunt Flo's Kitchen Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Women between the ages of 18 and 25 who experience primary dysmenorrhea and have no pathological disorders. Exclusion Criteria: * Pregnancy or breast feeding within 6 months * Primary or secondary amenorrhea * Body mass index less than the 1st percentile or body weight above 300 lbs * Undergoing menstrual suppression by medicative means * Unwilling to avoid painkillers (ibuprofen or naproxen) for the duration of the study unless absolutely necessary * Has allergies or aversions to ingredients used in either Cramp Bites or the Placebo Snack * Not fluent in English

Study Objectives This phase II study is designed to investigate the efficacy of IORT for patients with resectable pancreatic adenocarcinoma. The purpose of the study is to show the local recurrence rate after surgical resection and IORT is superior to that of surgical resection alone from the historical control. A total of 42 patients will be enrolled, and these patients will receive IORT of 10 Gy at 5 millimeter depth of the tumor bed, followed by 6 cycles of adjuvant gemcitabine chemotherapy. Conditions: Resectable Pancreatic Adenocarcinoma Intervention / Treatment: DEVICE: Intraoperative radiation therapy (IORT) Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * 1. Pathologically confirmed pancreatic adenocarcinoma 2. Age ≥20 years 3. Performance status ECOG 0-2 4. Patients must have resectable disease. In order to be resectable the following criteria must be met: * Absence of distant metastases * Clear fat planes around the celiac axis, hepatic artery, and superior mesenteric artery * Absence of direct involvement of inferior vena cava or aorta * Stage I-III disease per AJCC 7th edition 5. Laboratory data obtained ≤14 days prior to registration on study, with adequate bone marrow and renal function defined as follows: * Hemoglobin >10 g/dL, Absolute Neutrophil Count (ANC) >1,500/mm3, Platelets >100,000/mm3 * Serum Cr <1.4 mg/dL, BUN <20 mg/dL 6. Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * 1. Patients who have received external beam radiotherapy in the abdominal area 2. Defined treatment area which cannot be adequately covered by the radiation field as defined by the radiation oncology treatment team 3. Patients who have received neoadjuvant chemotherapy 4. Stage IV disease 5. Patients with distant metastases 6. Current pregnancy or currently nursing

Study Objectives Current standard of care for post-operative analgesia after breast surgery in CDHA is Tylenol #3® (300 mg acetaminophen, 30 mg codeine, 15 mg caffeine per tablet). We are proposing to test the analgesic efficacy of acetaminophen plus ibuprofen against Tylenol #3® in patients undergoing outpatient breast surgery. Conditions: Pain, Breast Diseases Intervention / Treatment: DRUG: acetaminophen plus codeine, DRUG: acetaminophen plus ibuprofen Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * ages 18 to 70 inclusive * outpatient breast surgery: lumpectomy; mastectomy, simple or modified; with or without sentinel lymph node biopsy, axillary node dissection. Exclusion Criteria: * allergies to acetaminophen, NSAIDs, ASA or codeine. * asthma. * recent reported history of upper GI bleeding. * daily analgesic use (OTC or opioid) pre-operatively. * any opioid use in the week prior to surgery. * reported history of PUD if not on PPI regularly. * anticoagulant use (low dose ASA excepted). * renal disease or impairment. * reported history of liver disease. * pregnancy. * major operative complications. * patients requiring admission. * communication barrier. * cognitive or memory impairment. * reported history of drug and/or alcohol abuse.

Study Objectives Ninety women with PCOS candidate for ICSI were randomized to 2 groups:Group A: fresh samples of PCOS patients undergoing IVF (no= 45) and Group B: frozen samples of PCOS patients undergoing IVF (no= 45). Morphologically good embryos will be cultured in a culture dish and the supernatants will be collected freshly from culture system at day 3 and stored at -20 ̊ c until being tested. Morphologically good embryos scheduled for freezing will be cryopreserved for less than one year and thawed, the supernatant will be collected and stored at -20 ̊ c until being tested. Quantification of mtDNA in fresh and frozen culture media using qPCR technique.The template DNA prepared and the dilution standards prepared will be used for qPCR to determine the amount of MtDNA and nuclear DNA in the sample using QuantiTect SYBR Green PCR Kit Conditions: Polycystic Ovary Syndrome, Assisted Reproduction Location: Egypt Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Age: 20-35 yrs. * BMI: ≤25. * PCO: diagnosed by Rotterdam criteria (at least two of the following): 1. Polycystic ovary morphology with one ovary being sufficient for diagnosis. 2. Hyperandrogenism: clinically or biochemically. 3. Anovulation or oligo-ovulation. * Gravidity and parity: Nulligravida. * Compliance: primary infertility Exclusion Criteria: * Known medical problems as diabetes mellitus, hypertension, cardiac, hepatic or renal problem. * Special habits of medical importance as smoking. * Other endocrinopathies

Study Objectives This single arm study will assess the safety and efficacy of Tarceva monotherapy in patients with advanced non-small cell lung cancer. Patients will receive Tarceva 150mg p.o. daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Conditions: Non-Squamous Non-Small Cell Lung Cancer Intervention / Treatment: DRUG: erlotinib [Tarceva] Location: Russian Federation Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * adult patients >= 18 years of age; * inoperable, locally advanced, recurrent or metastatic (Stage IIIB/IV) non-small cell lung cancer; * ECOG performance status of 0-3; * previously untreated, or failed on one prior course of standard systemic chemotherapy and/or radiotherapy. Exclusion Criteria: * prior systemic anti-tumor therapy with HER1/EGFR inhibitors; * unstable systemic disease; * any other malignancies within 5 years (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer; * any significant ophthalmologic abnormality.

Study Objectives This is an implementation science study that examines implementation of a single intervention and the development of practice-level implementation strategies to facilitate implementation of the intervention. Conditions: Breast Cancer Screening, Colorectal Cancer Screening, Implementation Intervention / Treatment: OTHER: Practice-Level Implementation Strategies Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SCREENING Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * To participate, individuals must be over the age of 18 and employed at a participating Community Health Center. Exclusion Criteria: * None

Study Objectives Complete resection is still the only curative treatment option in patients with soft tissue sarcoma (STS). Patients with a non-resectable STS have a dismal prognosis even without evidence of metastatic disease. The aim of this trial is to determine whether neoadjuvant dose-intensive chemo-radiotherapy is a feasible and effective approach in patients with non-resectable STS. Conditions: Sarcoma, Soft Tissue Intervention / Treatment: DRUG: Adriamycin, DRUG: Ifosfamide, DRUG: Etoposide, DRUG: Carboplatin Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed STS with locally advanced non-resectable disease * Metastatic disease is allowed in case of solitary resectable metastases * Grading according to Coindre > II° * Measurable tumor lesions * Age > 18 through 65 years * Karnofsky status > 70 % * Written informed consent Exclusion Criteria: * Prior chemotherapy * Intercurrent disease interfering with the adequate administration of study medication including severe psychological disease * Insufficient liver-, renal or bone marrow function * Evidence of pregnancy * Treatment within another clinical trial * Uncontrolled viral Infections (HIV,HBV, HCV) * other malignancies

Study Objectives The present study aims to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the Global Leadership Initiative on Malnutrition (GLIM) criteria. Conditions: Cancer of Stomach, Cancer of Esophagus, Malnutrition, Muscle Loss Intervention / Treatment: OTHER: no intervention Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: Elective surgery for esophagogastric cancer (there was a clear pathological diagnosis before surgery); NRS2002≥3; Preoperative BIA examination was performed. Exclusion Criteria: Discharged from a hospital within 24 hours; No BIA examination and not suitable for BIA examination (such as ascites, edema, amputation and pace-maker); Hepatic insufficiency (alanine transaminase/aspartate transaminase ratio 200% above normal range or bilirubin>3mg/dL) ; Renal insufficiency (serum creatinine>1.5mg/dL); Emergency operation; Pregnancy; Missing the postoperative information follow-up data.

Study Objectives To evaluate an iPad based photoimage analysis system (Moletest) for improving discrimination of benign from malignant suspicious skin lesions or moles. Specifically the objective is to demonstrate that the Moletest system is able with a sufficient degree of confidence (95%) to identify lesions which are benign Conditions: Melanoma Location: United Kingdom Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: All patients referred to the Dermatology Department, Lanarkshire Hospitals during a period to be defined for assessment of suspicious skin lesions (cutaneous moles) will be eligible for inclusion in the study. There are no age limits but patients under the age of 18 years will also have their inclusion subject to parental/guardian consent Exclusion Criteria: There is no exclsion criteria

Study Objectives The purpose of this study is to evaluate complete molecular response of Dasatinib in patients for Philadelphia chromosome-positive chronic myeloid leukemia Conditions: Chronic Myeloid Leukemia Intervention / Treatment: DRUG: dasatinib Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Chronic Myeloid Leukemia in the Chronic Phase * 20 years old over * ECOG performance status (PS) score 0-2 * Patients for major molecular response (MMR) with no CMR * Adequate organ function (hepatic, renal and lung) * Signed written informed consent Exclusion Criteria: * A case with the double cancer of the activity * Women who are pregnant or breastfeeding * The case of Pleural effusion clearly * Patients with complications or a history of severe or uncontrolled cardiovascular failure following * have a Myocardial infarction within 6 months * have an Angina within 3 months * have a Congestive heart failure within 3 months * have a suspected congenital QT syndrome * have a QTc interval of more than 450msec at baseline * A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy * Prior treatment with dasatinib * Subjects with T315I, F317L and V299L BCR-ABL point mutations

Study Objectives RATIONALE: Mammography reminders may encourage women to undergo regular mammography screenings for breast cancer. PURPOSE: This randomized clinical trial is studying three different mammography reminder interventions to compare how well they work in encouraging women to undergo regular mammography screenings for breast cancer. Conditions: Breast Cancer Intervention / Treatment: BEHAVIORAL: Mammography appointment reminders; telephone counseling Study Design and Phases Study Type: OBSERVATIONAL

Inclusion criteria: * Women members of The North Carolina Teachers' and State Employees' Comprehensive Major Medical Plan (SHP) * Age 40-75 * Enrolled with the SHP for at least 24 months, not covered by COBRA or Medicare primary * Based on claims data, women will have had their last mammogram 6-8 months ago so reminders will arrive 2 months prior to due date for next mammogram. Exclusion criteria: * Unable to speak and understand English. We lack the resources to adapt the intervention appropriate for non-English speakers. Moreover, we do not know if the interventions lend themselves to cultural translation. We regard this as a next logical research activity. * Have breast cancer or have some other illness that precludes participation. Women diagnosed with breast cancer before the study are ineligible; their screening schedules are consistent with recommendations for the general population. However, if women develop breast cancer during the study, we would ask them a reduced set of questions. We selected age 75 as the upper limit, because there are too few women over age 75 to permit meaningful statistical analysis (<100 women in all). The SHP is largely a working population. We wish that it were possible both to include and analyze women older than age 75. This is a limitation of the population we have selected.

Study Objectives Preoperative three-dimensional (3D) lung reconstructions can reduce intraoperative blood loss, conversion rate, and operation duration. Commercial products predominantly provide these 3D reconstructions, hence the aim of this study was to assess the usability and performance of preoperative 3D lung reconstructions created with open-source software. Conditions: Lung Cancer, Thoracic Surgery, Video-Assisted, Lobectomy, Segmentectomy, Humans, Surgery Intervention / Treatment: DEVICE: Preoperative 3D lung reconstruction created with open-source software Location: Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DEVICE_FEASIBILITY Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Patients with suspected or biopsy-proven lung cancer scheduled for video-assisted thoracoscopy surgery for lobectomy or segmentectomy Exclusion Criteria: * Computed Tomography scan contained motion artifacts * Surgery was canceled * Planned surgery changed intraoperatively to another procedure * Patients who did not provide informed consent

Study Objectives This randomized clinical trial focused on activating the patient to ask their health care provider for a colorectal cancer screening test to improve screening rates for colorectal cancer. The patient activation intervention may increase information seeking, number of screening tests ordered and number of completed screening tests for colorectal cancer. Conditions: Colon Cancer, Rectal Cancer Intervention / Treatment: OTHER: educational intervention, OTHER: educational intervention, OTHER: questionnaire administration Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SCREENING Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patient is 50+ years of age * Patient is in need of CRC screening * Patient is in good health (e.g. no contraindications to having CRC screening, such as a history of colorectal cancer, congenital heart failure, renal failure, dialysis, dementia, severe arthritis, etc.) * Patient is not pregnant * Patient is able to speak, read, and understand English Exclusion Criteria: * Patient is within CRC screening guidelines * Patient is at high risk for CRC * Patient cannot understand English * Patient cannot complete a CRC screening test

Study Objectives This phase I/II trial is studying the side effects and best dose of sorafenib when given together with cetuximab and irinotecan and to see how well they work in treating patients with advanced or metastatic colorectal cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib and cetuximab may also stop tumor growth by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to kill tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with cetuximab and irinotecan may kill more tumor cells Conditions: Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage III Colon Cancer, Stage III Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer Intervention / Treatment: DRUG: sorafenib tosylate, DRUG: cetuximab, DRUG: irinotecan hydrochloride 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: * Histologically or cytologically confirmed colorectal cancer (advanced or metastatic disease not amenable to potential curative resection) * Archival tumor (blocks and/or slides) must be available for patients who decline tumor biopsies * Tumor must be amenable to sequential biopsies for patients willing to undergo tumor biopsy * Must have evidence of disease progression after first-line chemotherapy for advanced disease * Previously irradiated lesions are not considered measurable disease * Measurable disease, defined as >= 1 unidimensionally measurable target lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan * No known brain metastases * Eastern Cooperative Oncology Group (ECOG) 0-2 OR Karnofsky 60-100% * Life expectancy of more than 12 weeks * white blood cell count (WBC) >= 3,000/mm\^3 * Bilirubin normal * Creatinine normal OR creatinine clearance >= 60 mL/min * No hypertension * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Able to swallow oral medication * Willing to undergo 2 sequential tumor and skin biopsies * No ongoing or active infection * No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness * No prior cetuximab * No concurrent prophylactic filgrastim (G-CSF), sargramostim (GM-CSF) or epoetin alfa * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No other concurrent chemotherapy * More than 4 weeks since prior radiotherapy and recovered * No prior sorafenib * No other prior therapy targeted against MAPK * More than 14 days since prior and no concurrent administration of the following cytochrome P450 3A4 (CYP3A4) inducers: * Rifampin * Rifabutin * Hypericum perforatum (St. John's wort) * Phenytoin * Carbamazepine * Phenobarbital * More than 7 days since prior and no concurrent administration of the following CYP3A4 inhibitors: * Amiodarone * Clarithromycin * Diltiazem * Erythromycin * Grapefruit juice * Indinavir * Saquinavir * Lopinavir in combination with ritonavir * Fosamprenavir * Ritonavir * Atazanavir * Nelfinavir * Itraconazole * Ketoconazole * Nefazodone * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational agents * No other concurrent anticancer therapy * Negative pregnancy test * Fertile patients must use effective contraception * Absolute neutrophil count >=1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * No evidence of bleeding diathesis * Aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 times upper limit of normal

Study Objectives The purpose of this study is to compare the efficacy and the safety Larotaxel administered as single agent every 3 weeks to continuous administration of 5-FU every 3 weeks, in patients with advanced pancreatic cancer (non operable in a curative intent, locally recurrent or metastatic) previously treated with gemcitabine based therapy. Conditions: Pancreatic Neoplasms Intervention / Treatment: DRUG: Larotaxel (XRP9881), DRUG: 5-Fluorouracil, DRUG: Capecitabine Location: Turkey, Hungary, United Kingdom, Italy, Germany, Brazil, Poland, Belgium, Peru, Chile, United States, Colombia, Mexico, Canada, India, Spain, Czech Republic, Norway, Russian Federation, Finland, Slovakia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Advanced (non operable in a curative intent, locally recurrent or metastatic disease) Cytologically or histologically proven epithelial cancer (adenocarcinoma) of the exocrine pancreas. * Patient must be previously treated with a systemic gemcitabine based regimen * Adequate bone marrow, kidney and liver functions Exclusion Criteria: * ECOG performance status (PS) of 2-3-4. * Prior locoregional radiotherapy for pancreatic cancer. * Symptomatic brain metastases or leptomeningeal disease. * Any serious intercurrent infections, uncontrolled cardiac or gastro-intestinal diseases. * Other concurrent malignancy * Other protocol-defined exclusion/inclusion criteria may apply

Study Objectives The proposed trial will address two clinically important questions for younger patients with newly diagnosed acute myeloid leukemia (AML): the optimal dose of daunorubicin in induction therapy and the necessity of a second induction cycle in patients with a good response after the first induction. The primary endpoint is the rate of good responders. Secondary outcomes will be relapse-free survival, overall survival and minimal residual disease kinetics. Patients will be recruited in about 40 treatment centers of the Study Alliance Leukemia study group over a period of 40 months. The results will be of great clinical relevance: First, the study could facilitate the establishment or confirmation of the optimal daunorubicin dose. Conditions: Leukemia, Myelocytic, Acute Intervention / Treatment: DRUG: study part 1 - dose daunorubicin, PROCEDURE: induction cycles Location: Czechia, Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: FACTORIAL Masking: NONE

Inclusion Criteria: * Newly diagnosed AML other than acute promyelocytic leukemia (APL) according to WHO criteria, i.e. bone marrow aspirate or biopsy must contain ≥20% blasts of all nucleated cells or differential blood count must contain ≥20% blasts. In acute erythroid leukemia, ≥20% blasts in all non-erythroid bone marrow cells. In AML defined by cytogenetic aberrations, the rate of blasts may be <20%. Secondary AMLs are eligible for inclusion. * Age 18- inkl.65 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Adequate liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: * Total bilirubin ≤ 1.5 times the upper limit of normal * alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 times upper limit of normal * Creatinine ≤ 1.5 times upper limit of normalExclusion Criteria: * Adequate cardiac function, i.e. left ventricular ejection fraction (LVEF) of ≥ 50% as assessed by transthoracic two-dimensional echocardiography ("M Mode") or multiple gated acquisition scan (MUGA scan) * Signed informed consent * Women must fulfill at least one of the following criteria in order to be eligible for trial inclusion: * Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with Serum follicle stimulating hormone (FSH) > 40 U/ml) * Postoperative (i.e. 6 weeks) after bilateral ovariectomy with or without hysterectomy * Continuous and correct application of a contraception method with a Pearl Index of <1% (e.g. implants, depots, oral contraceptives, intrauterine device - IUD). * Sexual abstinence * Vasectomy of the sexual partner Exclusion criteria: * Patients who are not eligible for standard chemotherapy as assessed by the treating physician * Central nervous system manifestation of AML * Cardiac disease: i.e. heart failure New York Heart Association (NYHA) III or IV; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * Patients undergoing renal dialysis * Chronic pulmonary disease with clinical relevant hypoxia * Known HIV or Hepatitis infection * Uncontrolled active infection * Medical conditions other than AML with an estimated life expectancy below 6 months * Previous treatment of AML except hydroxyurea up to 5 days * Relapsed or primary refractory AML * Acute promyelocytic leukemia * Previous anthracycline-containing chemotherapy * Treatment with any known non-marketed drug substance or experimental therapy within 4 weeks prior to enrollment * Incapability of understanding purpose and possible consequences of the trial * Pregnant or breastfeeding women * Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lacking compliance)

Study Objectives Nowadays, high-quality cancer care is more than just diagnosis and treatment of cancer. Healthcare must respond to the specific needs of the patients to provide patient-centered care. To date, research on the unmet supportive care needs in bladder cancer patients undergoing radical cystectomy is scarce. Because the needs of the patients may differ according to the phase in the illness trajectory, it is important that prospective research is carried out. Research in other cancer populations shows that unmet supportive care needs are negatively associated with health-related quality of life, psychological distress, physical activity and the health literacy of the patient. By incorporating the above factors into this study, we can not only map the unmet supportive care needs of the patient, but also explore possible associations between the variables. Since this is the first prospective study on supportive care needs in bladder cancer, this is a hypothesis-generating study. Conditions: Bladder Cancer, Urologic Cancer, Surgery Location: Belgium Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * age is 18 years or older * Patients diagnosed with bladder cancer who will undergo radical cystectomy * Patient has to be able to sign informed consent Exclusion Criteria: * Metastatic cancer * Presence of a second primary tumor with the exception of fully deleted prostate cancer, non-melanoma skin tumor or tumor diagnosed ≥ 5 years ago and under control

Study Objectives The purpose of this study is to compare reproducibility of the device position and location of the prostate rectum interface between two immobilization devices for radiation therapy of prostate carcinoma. Conditions: Adenocarcinoma of the Prostate Intervention / Treatment: DEVICE: Miller Air tip, DEVICE: Radiadyne Immobilizer Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * 18 years of age or older * Clinically localized T1-3 N0-1 M0 adenocarcinoma of the prostate * Planned definitive radiation therapy Exclusion Criteria: * Prior proctectomy * Rectal surgery within one year * Proctitis * Rectal carcinoma * Anal Stenosis * History of inflammatory bowel disease * Scleroderma * Systemic sclerosis * Refusal of treatment with immobilization device

Study Objectives To assess the efficacy of pregabalin in the management of mucositis pain in patients receiving radiotherapy to the head and neck. Eligible study subjects will be enrolled among those being treated for oropharyngeal cancer with definitive chemotherapy and radiation therapy (photons) to the head and neck in the Department of Radiation Oncology at the University of Pennsylvania. Conditions: Oropharyngeal Cancer, Squamous Cell Carcinoma to the Head and Neck Intervention / Treatment: DRUG: Lyrica 300 mg, DRUG: Placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL

Inclusion Criteria: * Patients being treated for oropharyngeal cancer with undergoing concurrent chemotherapy and radiation therapy (photons) for a histological diagnosis of squamous cell carcinoma to the head and neck at the University of Pennsylvania * Age at least 18 years old * Treatment entails significant risk for symptomatic mucositis likely to require opioid analgesia, as per the discretion of treating physician/NP * Subjects are capable of giving informed consent Exclusion Criteria: * Patients anticipated to receive radiation therapy with Protons * History of hypersensitivity to pregabalin or gabapentin * History of seizure or currently taking anti-epileptic medication * Creatinine clearance of less than 30 mL/min by Cockcroft-Gault estimate * Has another painful condition requiring chronic use of opioid analgesic, gabapentin, or pregabalin * History of serious mood disorder or attempted suicide as determined by patients history and physical and by using theDepression Screening * Subjects with a score of greater than 10 or those answering #5 with scores greater than a "0" will be deemed ineligible to be enrolled on study * History of angioedema * New York Heart Association class III or IV heart failure * Platelets of less than 150 mg/dL or history of thrombocytopenia * The patient has any uncontrolled intercurrent illness including but not limited to psychiatric illness/social situations that would limit compliance or interfere with their ability to participate

Study Objectives This is a Phase 1b, multicenter, open-label, dose-escalation study designed to estimate the maximum tolerated dose (MTD) and determine the recommended Phase 2 dose (RP2D) of ADXS31-164. Once the RP2D has been selected, up to 4 expansion cohorts will be evaluated. Conditions: HER2 Expressing Solid Tumors Intervention / Treatment: DRUG: ADXS31-164 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: * HER2 Positive * Have histological or cytological diagnosis of locally advanced/metastatic HER2 solid tumors that has progressed or become intolerant to standard therapy or for which no standard therapy is available * Have measurable and/or evaluable disease based on RECIST 1.1. * ECOG performance status of 0 to 1 Exclusion Criteria: * Is newly diagnosed with a curative treatment option available. * 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 trial treatment. * Has had a prior monoclonal antibody therapy within 2 weeks prior to study Day 1. (Prior anti-HER2 therapy is acceptable). * Has received anticancer chemotherapy, surgical treatment, and/or radiation therapy (except palliative radiation therapy for disease-related pain with a consult with the sponsor's medical monitor) within ≤2 weeks of first study treatment. * Is dependent on, currently or has received within the past 4 weeks corticosteroids (hormone replacement therapy, topical corticosteroids and occasional inhaled corticosteroids are allowed). * Has a contraindication to administration of trimethoprim/sulfamethoxazole or ampicillin. * Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)). NOTE: More common devices and prosthetics which include arterial and venous stents, dental and breast implants, and venous access devices (e.g., Port-a-Cath or Mediport) are permitted. Sponsor must be contacted prior to consenting any subject who has any other device and/or implant.

Study Objectives Previous researches demonstrated that a prepackaged low-residue diet (LRD) could achieve better bowel preparation quality compared with a self-prepared LRD. However, up to now, there has been no widely acceptable standard of LRD for bowel preparation. Moreover, these prepackaged LRD adopted in previous studies mainly consisted of traditional foods without further processing. Recently, a prepackaged LRD for Special Medical Purpose was specifically designed for bowel preparation. This trail was to compare the impact of the prepackaged LRD on bowel preparation for colonoscopy with self-prepared LRD by patients. Conditions: Colon Polyp, Colorectal Adenoma Intervention / Treatment: DIETARY_SUPPLEMENT: Prepackaged Low-residue diet, DIETARY_SUPPLEMENT: Self-prepared Low-residue diet Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Patients whose age is between 18-65. * Patients who have indications for screening, surveillance and diagnostic colonoscopy. * Patients who have signed inform consent form Exclusion Criteria: * subjects who had known or suspected heart failure, stroke or renal failure; * subjects who had a history of colon surgery or inflammatory bowel disease; * subjects who Patients with had digestion or absorption dysfunction or any dietary restriction due to various reasons; * subjects who had a history of hypersensitivity to any ingredients of laxatives or soy products; * subjects who had high risk factors for bowel preparation such as chronic constipation, Body Mass Index (BMI) greater than 30 or BMI less than 18 Kg/m2, diabetes, spinal cord injury, or use of medications affecting bowel motility within a week; * subjects who had participated in another interventional clinical trial in the previous 60 days; * pregnant or lactating women and those planning to become pregnant.

Study Objectives The purpose of this study is to investigate Pharmacokinetics parameters of a single dose \[14C\] AC0010 in male Patients With Advanced NSCLC. Conditions: Carcinoma, Non-Small-Cell Lung Intervention / Treatment: DRUG: AC0010 Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * signed and dated informed consent * histologically or cytologically confirmed diagnosis of local advanced or recurrent NSCLC * failed to the treatment of EGFR-TKI and harbored T790M mutation * male, Age 18\~ 65, have a body mass index (BMI) >19 kg/m2 * ECOG PS:0-1,Life expectancy of more than 3 months * main organs function is normal, laboratory values as listed below: blood test without blood transfusion within 14 days 1. Haemoglobin >100 g/L 2. Absolute neutrophil count ≥2.0x10\^9/L or WBC ≥3.5 x10\^9/L 3. Platelet count ≥ 80x10\^9/L 4. Total bilirubin ≤1.5xULN 5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN) 6. BUN≤1.5xULN 7. Serum creatinine ≤1.5xULN or creatinine clearance ratio ≥60 mL/min * Any prior treatment (chemotherapy, radiotherapy or surgery) must be completed over 4 weeks(target therapy over 2 weeks) from the screening; Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 (CTCAE v 4.03) * International normalized ratio (INR) ≤ 1.5 * Patients and their partners should be willing to use methods of contraception or total abstinence from start of dosing until 6 months after discontinuing of study treatment Exclusion Criteria: * Prior treated with AC0010 or allergic to drug or its formulation ingredients * Patients receiving other anti-tumor therapy * Impairment of GI disease, renal disorders or liver disease that may significantly alter the absorption and metabolic of AC0010 (e.g., Unable to swallow, liver, kidney or gastrointestinal partial resection, chronic diarrhea and intestinal obstruction) * HCVAb positive, active hepatitis B (excluding HBV carriers), Hepatitis virus markers positive and receiving anti-virus drugs * Meningeal metastasis; brain metastasis with whole brain radiotherapy; prior received hormones or mannitol for the brain metastasis * Previous EGFR-TKI treatment related Interstitial lung disease history * Known human immunodeficiency virus infection (HIV), other acquired or congenital immunodeficiency disease, or a history of organ transplantation * Any severe and / or uncontrolled active infections * Patients receiving concomitant immunosuppressive agents or high-dose corticosteroids * Any severe and / or uncontrolled medical conditions * Patients being treated with drugs recognized as being inhibitors or inducers of the liver isoenzyme in the last 4 weeks prior to registration in the current study * Within 3 days prior to the treatment intaking of pitaya, pomelo, grapefruit, orange, mango and other fruit may affect drug metabolizing enzymes or juice * Within 2 days prior to the treatment intaking of coffee, tea, cola, chocolate, or other caffeine containing beverages, alcoholic beverages and / or other alcoholic products * Major surgery, incisional biopsy or traumatic injuries; * Within 4 weeks prior to the screening patients with bleeding ≥ grade 3, non-healing wound, sever ulcer or bone fracture * Patients received high dose irradiation treatment or other 14C-labeled drug within 1 year * Known a history of alcoholism or drug abuse * Nicotine or urine drug testing was positive * Participate in any clinical trial within 4 weeks prior to the screening * Investigator judgment that patient is unsuitable to participate in study

Study Objectives The purpose of this program is to evaluate the safety, tolerability, and efficacy of the new concomitant and sequential temozolomide regimen in newly diagnosed Glioblastoma patients in a routine care setting. Conditions: Glioblastoma Intervention / Treatment: DRUG: Temozolomide, RADIATION: Radiotherapy Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Newly diagnosed Glioblastoma multiforme Exclusion Criteria: * History of hypersensitivity to temozolomide or its components, or to dacarbazine. * Women who are pregnant or breast-feeding. * Patients with severe myelosuppression.

Study Objectives To compare the decision making of subjects with advanced cancer having a verbal advance care planning discussion compared to subjects using a video. Conditions: Advanced Cancer Intervention / Treatment: BEHAVIORAL: video decision aid Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: HEALTH_SERVICES_RESEARCH Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * diagnosis of cancer that falls under one of the following: A. All patients with brain cancer, inoperable hepatocellular/bile duct/gallbladder cancer, incurable non-small cell lung carcinoma (wet IIIb or IV), extensive stage small cell lung cancer, inoperable mesothelioma, inoperable pancreatic cancer or; metastatic gastric or esophageal cancer, metastatic melanoma, OR B. Patients with the following cancers, if first-line therapy has failed and limited response is expected to second-line therapy: breast cancer, colorectal cancer, head and neck cancer, leukemia, ovarian cancer, prostate cancer, renal cancer, sarcoma, lung cancer, myeloma, or lymphoma, OR C. Less than one year prognosis. * ability to provide informed consent, * cognitive ability to participate in the study * ability to communicate in English. Exclusion Criteria: * inability to make decisions, * non-English speaking, * new patient visit

Study Objectives The purpose of this study is to assess the efficacy and safety of the one-stop-shop concept, using real-time in vivo reflectance confocal microscopy as diagnostic tool, prior to surgical management of new primary basal cell carcinoma Conditions: Carcinoma, Basal Cell Intervention / Treatment: DEVICE: Reflectance confocal microscopy, PROCEDURE: Punch biopsy, PROCEDURE: Surgical excision Location: Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients with clinically suspected new primary BCC as assessed by an experienced board certified dermatologist * Patients seen at the outpatient clinic before 12h00 AM will be eligible to participate * Patient is willing and able to give written informed consent * BCC lesion is suitable for conventional surgical excision under local anesthetics * BCC lesion is present since at least 1 month Exclusion Criteria: * BCC lesion in a high-risk location of the face (H-zone and ears) * Contra-indication for conventional surgical excision (primary surgical closure seems not achievable) * Recurrent BCC lesion (BCC that has been previously unsuccessfully treated) Macroscopic ulcerating BCC lesions (not feasible for RCM analysis due to technical reasons) * Patients with basal cell nevus syndrome * Patients treated with hedgehog inhibitor medication * Patients with a history of hypersensitivity to and/ or a history of allergy to local anesthesia * Unavailability within the following 6 weeks (for example due to holiday or sports) * Patients not competent to understand the procedures involved

Study Objectives The purpose of this study is to to investigate the effect of tocotrienol as a nutritional supplement in combination with bevacizumab in patients with advanced ovarian cancer. Conditions: Ovarian Cancer Intervention / Treatment: DRUG: Bevacizumab, DRUG: Tocotrinol Location: Denmark Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer. * Prior treatment with at least two different cytostatic regimens including platinum. * Progression on previous treatment. * Measurable disease by RECIST 1.1 or evaluable by GCIG CA-125 criteria. * Age ≥ 18 years. * Performance stage 0-2. * Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion): * WBC ≥ 3.0 \* 10\^9/l or neutrophils (ANC) ≥ 1.5 \* 109/l * Platelet count ≥ 100 \* 10\^9/l * Hemoglobin ≥ 6 mmol/l * Serum bilirubin < 2.0 \* ULN * Serum transaminase ≤ 2.5 \* ULN * Serum creatinine ≤ 1.5 ULN * Urine dipstick for protein <2+. If the dipstick shows protein ≥2+ 24 hour urine testing must be made with protein contents < 1 g. * Written informed consent. Exclusion Criteria: * Other malignant diseases within 5 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin and other types of cancer with minimal risk of recurrence. * Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation. * Underlying medical disease not adequately treated (diabetes, cardiac disease). * Uncontrolled hypertension (BT >150/100 despite antihypertensive treatment). * Surgery, incl. open biopsy, within 4 weeks prior to first dose of bevacizumab. * Non-healing wounds or fractures. * Cerebral vascular attack, transient ischemic attack or subarachnoidal hemorhage within 6 months before start of treatment. * Clinically significant cardiovascular disease, including: * Myocardial infarction or unstable angina within 6 months before start of treatment * New York heart Association (NYHA) class ≥ 2 * Poorly controlled cardiac arrhythmia despite medication * Periferal vascular disease grade ≥ 3 * Allergy to the active substance or any of the auxiliary agents * Bleeding tumor * Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory. * Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment

Study Objectives This research study is evaluating whether asking patients to fill out a brief survey about their goals and preferences for care and giving this survey to their clinician before the next visit helps improve communication and decision-making in breast cancer care. Conditions: Breast Cancer Intervention / Treatment: OTHER: IGCDG Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: HEALTH_SERVICES_RESEARCH Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age ≥ 18 * Diagnosed with stage IV breast cancer within the past 3 years * Receiving care at the MGH Cancer Center * Verbal and written fluency in English * Within 6 weeks of a new line of breast cancer therapy and/or progression on scans and/or a change in current breast cancer therapy regimen Exclusion Criteria: * Unwilling or unable to participate in the study * Is medically or otherwise unable to participate (as determined by a physician or study PI) * Enrolled in hospice

Study Objectives We aim to assess the incidence of oral and dental adverse events after high-dose radioiodine therapy for differentiated thyroid cancer. Conditions: Thyroid Cancer Intervention / Treatment: DRUG: Radioiodine Location: Switzerland Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * histologically confirmed differentiated thyroid cancer * status after total thyroidectomy * status after subsequent high-dose radioiodine treatment * regular follow-up by a board-certified dentist * a minimum follow-up of 1 year after radioiodine therapy. Exclusion Criteria: * anaplastic thyroid cancer

Study Objectives The purpose of the study is to evaluate dose limiting toxicity (DLT), investigate the tolerability and safety of eribulin mesylate with trastuzumab combination therapy, and estimate the recommended dose. Conditions: Breast Cancer Intervention / Treatment: DRUG: E7389 Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria * Females aged greater than or equal to 20 years and less than 75 years at the time of informed consent. * Histologically or cytologically confirmed with breast cancer * Score 3+ by immunohistochemistry (IHC) or HER2 positive by Fluorescence in Situ Hybridization (FISH) method * Subjects who meet any of the following criteria: * Evidence of recurrence during adjuvant chemotherapy with trastuzumab and taxane * Evidence of recurrence within 6 months after adjuvant chemotherapy with trastuzumab and taxane * Experienced prior chemotherapy including trastuzumab and taxane for advanced or recurrent breast cancer * Adequate organ function * Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) is 0 or 1 * Subjects who have submitted written informed consent for study entry Exclusion Criteria * Subjects with known brain metastasis accompanied by clinical symptoms or requiring active treatment * Subjects with severe active infection requiring active treatment * Subjects with large pleural effusions, ascites, or pericardial effusions requiring drainage. * Hypersensitivity to trastuzumab, halicondrin B or halicondrin B chemical derivatives * Known positive for human immunodeficiency virus (HIV) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV) by serum test. * Subjects who are pregnant (positive B-hCG test) or breastfeeding * Subjects judged to be ineligible for this study by the principal investigator or sub-investigator.

Study Objectives Hormone dynamics, pharmacokinetics, safety, and efficacy of TAP-144-SR(6M) will be evaluated against TAP-144-SR(3M) in postoperative and hormone therapy-naïve patients with premenopausal breast cancer Conditions: Premenopausal Breast Cancer Intervention / Treatment: DRUG: TAP-144-SR(6M), DRUG: TAP-144-SR(3M) Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * The participant has histopathologically-confirmed primary breast cancer in Japanese. * The participant is aged 20 years or older when informed consent is obtained * The participant has estrogen receptor (ER)-positive tumor cells and/or progesterone receptor (PgR)-positive primary tumor. And HER-2 is negative. * The participant has breast cancer in the clinical stages of T1-T3, N-any and M0 by TNM classification (the seventh edition, proposed by UICC in 2009). (No distant metastasis to lung, liver and bone should be confirmed on the image-based diagnosis at study enrollment. The image taken within 12 weeks prior to study enrollment is also available for the diagnosis.) The number of axillary lymph node metastasis is not limited. * Any operative procedure for breast cancer is acceptable. In principle, after breast-conserving surgery, the participant will receive postoperative radiation to the conserving breast. * Neoadjuvant chemotherapy and adjuvant chemotherapy prior to study enrollment are acceptable. (It is advisable the same kind of chemotherapy is performed at each site.) * The participant has a history of regular menstrual periods within 12 weeks prior to study enrollment, or the participant has FSH of less than 40 mIU/mL and E2 of 10 pg/mL or more measured within 12 weeks prior to study enrollment. The participant has not had a chemical menopause (i.e., FSH of less than 40 mIU/mL and E2 of 10 pg/mL or more) within 12 weeks after completing adjuvant chemotherapy. * The participant is in a condition to receive study drug and Tamoxifen (TAM) within 12 weeks after surgery or after adjuvant chemotherapy prior to study enrollment. Adjuvant chemotherapy prior to study is required to have been completed at the time of study enrollment. * The participant has ECOG performance status of grades 0 or 1 at the time of study enrollment. * The participant meets the following criteria of hepatic, renal and bone marrow functions on the laboratory test results at screening: * Hepatic function: AST (GOT) ≤ 3.0 times the upper limit of normal (ULN) ALT (GPT) ≤ 3.0 times the ULN * Renal function: serum creatinine level < 1.5 times the ULN * Bone marrow function : white blood cell count ≥ 3,000/mm3 platelet count ≥ 100,000/μL hemoglobin ≥ 10.0g/dL * The participant agrees to use a non-hormonal method of contraception through the study period. Exclusion Criteria: * The participant has received neoadjuvant or adjuvant hormonal therapy for the latest breast cancer surgery. * The participant has received bilateral oophorectomy and bilateral ovarian irradiation. * The participant has inflammatory breast cancer or bilateral breast cancer. * The participant has non-invasive ductal carcinoma. * The participant has multiple primary cancers, or a history of carcinoma in other organs. * The participant is pregnant or breast-feeding. * The participant has a history of hypersensitivity to synthetic LH-RH, LH-RH derivative, TAM, TAM analogue (antiestrogen) or any component of the study drug. * The participant has a history of, or has been diagnosed with thromboembolism including myocardial infarction, cerebral infarction, venous thrombosis, and pulmonary embolism, or cardiac failure. * Patients whose QTcF interval exceeded 460 msec on the 12-lead electrocardiogram at screening.

Study Objectives The investigators at PGIMER have been practicing hypofractionation radiotherapy with a dose of 35Gy/15#/3wks to the chest wall in post mastectomy and 40Gy/16#/3wks in breast conservation in breast cancer patients for the last 4 decades. It is also a routine practice in UK and few centers in Canada. Hypofractionation reduces treatment time to half while maintaining cosmesis and gives control rates equal to conventional fractionation. As breast cancer is a leading cancer in females and radiation therapy is an important part of its local management, hypofractionation help the radiation centers worldwide to meet the growing need for radiation in breast cancer, particularly in developing countries where resources are limited. It also reduces the financial burden on the patient and family. In this study the investigators want to reduce the treatment duration from 3 weeks to 2 weeks. The study will include 1000 patients, 500 in each arm, with breast cancer post mastectomy or after breast conservative surgery to be treated with a radiotherapy dose of 34Gy in 10 fractions over 2 weeks in the study arm and 35Gy in 15 fractions over 3 weeks in the control arm. The primary endpoint of the study will be ipsilateral local tumour control. Secondary endpoints will be early and late adverse effects in normal tissues, quality of life, contralateral primary tumours, regional and distant metastases and survival. Conditions: Breast Cancer Intervention / Treatment: RADIATION: Hypofractionated Radiation therapy Location: India Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Invasive carcinoma of the breast * Breast conservation surgery or mastectomy * Axillary staging \&/or dissection * Complete microscopic excision of primary tumour * pT1-3 pN0-2 M0 disease * Written informed consent * Able to comply with follow up Exclusion Criteria: * Past history of malignancy except (i) basal cell skin cancer and CIN cervix uteri or (ii) non-breast malignancy allowed if treated with curative intent and at least 5 years disease free * Contralateral breast cancer, including DCIS, irrespective of date of diagnosis * Breast reconstruction using implants * Concurrent cytotoxic chemotherapy (sequential neoadjuvant or adjuvant cytotoxic therapy allowed)

Study Objectives This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetic (PK) of GDC-0349 administered once daily (QD), orally (PO). Conditions: Non-Hodgkin's Lymphoma, Solid Tumor Intervention / Treatment: DRUG: GDC-0349 Location: Canada, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically documented, locally advanced or metastatic solid malignancy or NHL without leukemic phase that has progressed or failed to respond to at least one prior regimen and/or are not candidates for regimens known to provide clinical benefit * Evaluable or measurable disease per RECIST v1.1 or IWG response criteria for patients with NHL and/or the following: prostate cancer patients with non-measurable disease are eligible if they have two rising prostate-specific antigen (PSA) levels >= 5 ng/mL measured >= 2 weeks apart that meet the PSA, and Working Group criteria for progression prior to initiation of study treatment, and ovarian cancer patients with non-measurable disease are eligible if they have two rising CA-125 levels greater than the ULN >= 2 weeks apart prior to initiation of study treatment. * ECOG performance status of 0 or 1 at screening * Life expectancy of >= 12 weeks * Adequate hematologic and organ function within 14 days prior to initiation of study treatment * Documented willingness to use an effective means of contraception for both men and women while participating in the study and for 90 days after the last dose of GDC-0349 * Willingness to provide archival tumor tissue Exclusion Criteria: * Leptomeningeal disease as the only manifestation of the current malignancy * History of Type 1 or 2 diabetes requiring daily medication * Known untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for >= 3 months prior to initiation of study treatment * Active congestive heart failure or ventricular arrhythmia requiring medication * Uncontrolled ascites requiring weekly large-volume paracentesis for 3 consecutive weeks prior to initiation of study treatment * Active infection requiring intravenous (IV) antibiotics * Patients requiring any daily supplemental oxygen * Uncontrolled hypomagnesemia or hypokalemia * Any condition requiring anti-coagulants such as warfarin, heparin, or anti-thrombotics. Prophylactic anti-coagulation and/or local application of thrombolytic agents for catheter patency may be allowed for patients with normal INR and with prior approval from the Medical Monitor * Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis * Known human immunodeficiency virus (HIV) infection * Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or renders the patients at high risk from treatment complications * Significant traumatic injury within 3 weeks prior to initiation of GDC-0349 * Major surgical procedure within 4 weeks prior to initiation of GDC-0349 * Treatment with chemotherapy, hormonal therapy (except GnRH agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, or radiation therapy (except palliative radiation to bony metastases) as cancer therapy within 4 weeks prior to initiation of study treatment. Kinase inhibitors, approved by national regulatory authorities, may be used up to 2 weeks prior to initiation of GDC-0349, provided that any drug-related toxicity has completely resolved and prior approval is obtained from the Medical Monitor. * Palliative radiation to bony metastases within 2 weeks prior to initiation of GDC-0349 * Treatment with an investigational agent within 4 weeks prior to initiation of GDC-0349 * Unresolved toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy * Pregnancy or lactation

Study Objectives The purpose of this study is to test the combination of radiation treatment and an anti-angiogenic drug called sorafenib (or BAY 43-9006 or Nexavar) to determine the effects of this combination on cancers but also on side effects of radiation treatment. This study will also determine the highest safe dose of sorafenib that can be given with radiation treatment. Conditions: Cancer Intervention / Treatment: DRUG: Sorafenib Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Advanced cancer not eligible for curative treatment. * A measurable lesion in the thorax, abdomen or pelvis. * Normal organ and bone marrow function. * Able to receive protocol prescribed radiation. Please refer to the protocol for detailed inclusion criteria. Exclusion Criteria: * Overlap of treatment field with a previous radiation field. * Inability to meet mandated normal tissue radiation dose constraints. * Brain metastases (unless previously treated and controlled) * Previous treatment with Sorafenib. * Poorly controlled Hypertension. * Unable to swallow sorafenib tablets. * Intercurrent cardiac dysfunction. * Uncontrolled intercurrent illness. Please refer to the protocol for detailed exclusion criteria.

Study Objectives Hepatocellular Carcinoma (HCC) recurrence rate is high among liver transplant patients, while treatment measures are limited. This study plans to recruit 39 subjects with Hepatitis B virus (HBV) related HCC after liver transplantation. The objective of the study is to assess the safety, tolerability and effectiveness of the HBV specific T cell receptor (HBV/TCR) redirected T cell in the target population. Conditions: Hepatocellular Carcinoma Intervention / Treatment: BIOLOGICAL: TCR-T, BIOLOGICAL: No intervention and TCR-T (at crossover) Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: PREVENTION Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Diagnosis as hepatocellular carcinoma (HCC) * Underwent liver transplantation * Seropositive for hepatitis B surface antigen (HBsAg), or presence of HBV DNA or HBV RNA before liver transplantation * Expression of TCR-T target epitopes within specific human leukocyte antigen (HLA) class I profile * No major post-operative complication * Life expectancy of at least 3 months * Ability to provide informed consent * Ability to comply with study procedures Exclusion Criteria: * Known, clinically suspected or has history or central nervous system (CNS) and bone metastasis * Significant ongoing immunologic rejection based on pathology and clinical diagnosis * Evidence or history of significant bleeding diathesis or coagulopathy * Prior exposure to any cell therapy such as, but not limited to NK, CIK, DC, CTL, stem cells therapy * Known history of testing positive for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS) * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection * Women who are pregnant or breast-feeding * Any condition that is unstable or which could jeopardise the safety of the patient and his/her compliance in the study

Study Objectives This is a phase II, multicenter, open label, nonrandomized study to evaluate the efficacy and safety of lenalidomide at a dose of 10 mg/dose in combination with bortezomib at 1.0 mg/m2/dose, pegylated liposomal doxorubicin (PLD) at 4.0 mg/m2/dose, and intravenous (IV) dexamethasone at 40 mg/dose in adult patients with relapsed/refractory multiple myeloma (MM). The study consists of a screening period, followed by up to eight 28 day open label treatment cycles, a final assessment to occur 28 days after the end of the last treatment cycle, and a follow-up period. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: DVD-R 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: * Has a diagnosis of multiple myeloma (MM) based on standard criteria (Durie 1986) * Currently has MM with measurable disease (serum m protein > 1.0g/dl and/or 24 hr urine m protein > 200mg/24 hr) * Currently has progressive MM that has relapsed or is refractory * Voluntarily signed an informed consent * Age 18 years * Eastern Cooperative Oncology Group (ECOG) performance < 2 * Life-expectancy > 3 months * Laboratory test results within these ranges: * Absolute neutrophil count (ANC) 1.5 x 109/L; if the bone marrow is extensively infiltrated (> 70% plasma cells) then 1.0 x 109/L * Platelet count 75 x 109/L; if the bone marrow is extensively infiltrated (> 70% plasma cells) then 50 x 109/L * Hg > 8 g/dL * Calculated or measured creatinine clearance > 30 mL/minute. * Total bilirubin 2.0 x upper limit of normal (ULN) * Aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) 3 x ULN or 5 x ULN if hepatic metastases are present * Serum potassium within the normal range * Disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast * Registered into the mandatory RevAssist® program, willing and able to comply with the requirements of RevAssist®. * Females of childbearing potential must have a negative serum or urine pregnancy test and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control. * Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid (ASA) may use warfarin or low molecular weight heparin) Exclusion Criteria: * Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes syndrome * Plasma cell leukemia * Grade 2 peripheral neuropathy within 14 days before enrollment * Impaired cardiac function or clinically significant cardiac diseases, including myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class II or greater heart failure, Uncontrolled angina, clinically significant pericardial disease, severe uncontrolled ventricular arrhythmias, echocardiogram or Multigated acquisition(MUGA) scan evidence of left ventricular ejection fraction (LVEF) below institutional normal within 28 days prior to enrollment, electrocardiographic (ECG) evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant. * Severe hypercalcemia, i.e., serum calcium 12 mg/dL (3.0 mmol/L) corrected for albumin * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study * Undergone major surgery within 28 days prior enrollment or has not recovered from side effects of such therapy (Kyphoplasty is not considered to be a major surgery; however, the investigator is to discuss enrollment of a patient with a recent history of kyphoplasty with the medical monitor). * Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide) * Received the following prior therapy: * Chemotherapy within 3 weeks of enrollment (6 wks for nitrosoureas) * Corticosteroids (>10 mg/day prednisone or equivalent) within 3 weeks of enrollment * Immunotherapy or antibody therapy as well as thalidomide, lenalidomide, arsenic trioxide or bortezomib within 21 days before enrollment * Radiation therapy within 28 days before enrollment, except localized radiation therapy * Use of any other experimental drug or therapy within 28 days of enrollment * Known hypersensitivity to compounds of similar to thalidomide, doxorubicin, bortezomib, boron or mannitol. * The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs * Concurrent use of other anti-cancer agents or treatments * Known positivity for human immunodeficiency virus (HIV) or hepatitis B or C; baseline testing for HIV and hepatitis B or C is not required

Study Objectives The objective of this pharmacokinetic study is to exclude a possible influence of CETUX on the plasma disposition and metabolic activation of Capecitabine (CCB) and when this regimen is given combined with Oxaliplatin (OxPt). Conditions: Metastatic Colorectal Cancer Intervention / Treatment: OTHER: blood samples Location: Austria Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: BASIC_SCIENCE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria selected: * signed written informed consent * male or female > 18 years * K-ras wild type adenocarcinoma of the colon or rectum * metastatic colorectal carcinoma * ECOG <= 2 Exclusion Criteria selected: * brain metastasis * previous chemotherapy * stage 3 or 4 heart failure * uncontrolled angina * pregnancy or lactation

Study Objectives To determine if Accelerated Partial Breast Irradiation, using 3D CRT, is as effective as Whole Breast Irradiation following breast conserving surgery in women with an new histological diagnosis of ductal carcinoma in situ only or invasive breast cancer without evidence of metastatic disease. Effectiveness will be determined by the rate of ipsilateral breast tumour recurrence. General objective is to improve the convenience and quality of life of female patients who receive breast irradiation. Conditions: Breast Cancer Intervention / Treatment: RADIATION: APBI utilizing 3D-CRT radiation, RADIATION: Whole breast irradiation Location: Canada, New Zealand, Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * 1a. Female patient with a new histological diagnosis of DCIS only. OR 1b. Female patient with a new histological diagnosis of invasive carcinoma of the breast and no evidence of metastatic disease. 2. Treated by BCS with microscopically clear resection margins for invasive and non-invasive disease (or no residual disease on re- excision). 3. Negative axillary node involvement including micrometastasis <= 0.2mm or positive cells only identified by IHC as determined either by: (i) sentinel node biopsy (ii) axillary node dissection or (iii) clinical exam for patients with DCIS only Exclusion Criteria: * 1. Age < 40 years. 2. A known deleterious mutation in BRCA 1 and/or BRCA 2. 3. Tumour size > 3 cm in greatest diameter on pathological examination (including both the invasive and non-invasive component). 4. Tumour histology limited to lobular carcinoma only. 5. History of cancer: * Patients with another active malignancy or malignancy treated < 5 years prior to randomization are excluded. * Patients with a prior diagnosis of invasive or non-invasive breast cancer in either breast are excluded regardless of disease free interval. Patients with concurrent invasive or non-invasive contralateral breast cancer are also excluded. * Patients with prior or concurrent basal cell or squamous cell skin cancers are eligible for the trial. 6. More than one primary tumour in different quadrants of the same breast. 7. Previous irradiation to the ipsilateral breast that would preclude whole breast irradiation. 8. Presence of an ipsilateral breast implant or pacemaker. 9. Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment. 10. Estrogen receptor status (ER) not known. 11. For patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 12 weeks of the last surgical procedure on the breast. 12. For patients treated with adjuvant chemotherapy: unable to commence within 8 weeks of the last dose of chemotherapy. 13. Currently pregnant or lactating. 14. Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol. 15. Geographic inaccessibility for follow-up. 16. Inability to localize surgical cavity on CT (i.e., no evidence of surgical clips or seroma). 17. Inability to adequately plan the patient for the experimental technique.

Study Objectives This study was designed to compare the outcome of the anteromedial thigh (AMT) and anterolateral thigh (ALT) flaps in head and neck cancer reconstruction. Conditions: Reconstructive Surgery, Head and Neck Cancer Intervention / Treatment: OTHER: ALT flap reconstruction, OTHER: AMT flap reconstruction Location: Taiwan Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients who underwent ALT or AMT free flap reconstruction after head and neck cancer surgery between March 1, 2008 and February 28, 2017. Exclusion Criteria: * Patients whose data were missing will be excluded.

Study Objectives With roughly 80% of cancer patients receiving their oncology care in the community setting, the investigators are proposing to sample from a community-based center to evaluate the percentage of epidermal growth factor receptor (EGFR)-wild type patients that gain benefit from erlotinib and assess the clinical characteristics that are associated with erlotinib-responders. Additionally, biopsy specimens from enrolled patient cases that are EGFR-wt will be evaluated via exploratory genetic analysis for correlated markers. Conditions: Non Small Cell Lung Cancer Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients must have had NSCLC. * Patients must have received erlotinib (single-agent) for six months or longer for NSCLC in the second/third line setting or as maintenance therapy. * Patients must have tissue available for EGFR-mutation status testing (if not previously performed) or EGFR-mutation status test results available. * Patients must have tissue available for exploratory genetic analysis. * Patients must have all clinical information, treatment response data and outcomes data available for review. * Patients must be deceased.

Study Objectives This is a study of a regimen of melphalan and autologous stem cells for patients with multiple myeloma. We hypothesize that this particular regimen will improve the survival of these patients. Conditions: Multiple Myeloma Intervention / Treatment: PROCEDURE: Stem Cell Transplant, DRUG: Cyclophosphamide + Mesna, DRUG: Melphalan, BIOLOGICAL: Granulocyte-colony stimulating factor 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: * Patients meeting the Durie and Salmon criteria for initial diagnosis of multiple myeloma, requiring therapy and meeting one of the following: * After initial therapy in either first complete or partial remission or no objective response * After achieving initial response and later disease progression, patient will be eligible after subsequent therapy upon achievement of either complete or partial response * Is not eligible or has refused any protocols of higher priority * 18 - 75 years of age * Adequate organ function defined as: * Hematologic: hemoglobin ≥ 8 gm/dl (untransfused), white blood cells (WBC) ≥ 3000/μl, absolute neutrophil count (ANC) ≥ 1500/μl, platelets ≥ 100,000/μl (untransfused) * Cardiac: no active ischemia, left ventricular ejection fraction > 45% by MUGA scan * Hepatic: bilirubin < 2.0 mg/dl, ALT < 3x the upper limit of normal * Pulmonary: FEV1-Forced Expiratory Volume in One Second AND Forced vital capacity (FVC) >50% predicted and Carbon Monoxide Diffusing Capacity (DLCO) (corrected) > 50% predicted * Performance status: Karnofsky performance of > 80%. * Free of active uncontrolled infection at the time of study entry. * At time of study enrollment > 4 weeks from prior myelosuppressive chemotherapy; and > 6 weeks from prior nitrosoureas. * Patients must exercise informed voluntary consent and sign a consent form approved by the University of Minnesota IRB: Human Subjects Committee. Exclusion Criteria: * Patients will be ineligible if they have advanced myeloma refractory and unresponsive to salvage chemotherapy regimens. * Female patients who are pregnant (positive b-HCG) or breastfeeding will be excluded from study entry. In addition fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment, particularly after thalidomide will also be excluded from study entry.

Study Objectives Efficacy and safety of amifampridine phosphate in improving the activities of daily living for patients with antibody positive MuSK myasthenia gravis. Conditions: Myasthenia Gravis, Generalized Intervention / Treatment: DRUG: Amifampridine Phosphate, DRUG: Placebo Oral Tablet Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Willing and able to provide written informed consent after the nature of the study has been explained and before the start of any research-related procedures. * Male or female ≥18 years of age. * Positive serologic test for anti-MuSK antibodies or anti-AChR antibodies as confirmed at Screening or by previous antibody test, with report available. * Confirmatory EMG or EMG report. * Myasthenia Gravis Foundation of America (MGFA) Class II to IV at Screening. * MG-ADL score of ≥6 at Screening, with more than 50% of this score attributed to non-ocular items. * Patients receiving steroids or pyridostigmine should not have any modification of drug regimen during the month before Screening. * Female patients of childbearing potential must have a negative pregnancy test (serum human chorionic gonadotropin \[HCG\] at screening); and must practice an effective, reliable contraceptive regimen during the study and for up to 30 days following discontinuation of treatment. * Ability to participate in the study based on overall health of the patient and disease prognosis, as applicable, in the opinion of the Investigator; and able to comply with all requirements of the protocol, including completion of study questionnaires. Exclusion Criteria: * Epilepsy and currently on medication. * Concomitant use of medicinal products with a known potential to cause QTc prolongation. * Patients with long QT syndromes. * History of thymectomy within 12 months before Screening. * An electrocardiogram (ECG) within 6 months before starting treatment that shows clinically significant abnormalities, in the opinion of the Investigator. * Breastfeeding or pregnant at Screening or planning to become pregnant at any time during the study. * Patients receiving immunomodulatory treatment (e.g. plasma exchange \[PE\], therapeutic plasma exchange \[TPE\], intravenous immunoglobulin G \[IVIG\]) should not have any treatment in the previous 4 weeks prior to Randomization or at any time during the study. * Use of rituximab or other similar biologic medications for immunomodulation within 6 months prior to Screening. * Treatment with an investigational drug (other than amifampridine) or device within 30 days before Screening or while participating in this study. * Any medical condition that, in the opinion of the Investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confound the assessment of the patient. * History of drug allergy to any pyridine-containing substances or any amifampridine excipient(s).

Study Objectives The purpose of this study is to determine whether initial local irradiation with topotecan and following oral antiangiogenic drugs, thalidomide, celecoxib and etoposide are effective in the treatment of pediatric diffuse brainstem tumor. Conditions: Brainstem Glioma Intervention / Treatment: DRUG: Thalidomide, etoposide, celecoxib Location: Finland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: *pediatric diffuse brainstem tumor Exclusion Criteria: * wish of the family * need for strong painrelievers * decreased level of consciousness * inability to swallow.

Study Objectives The goal of this clinical research study is to determine the safety and effects of giving a special kind of immune cells called "alloreactive natural killer (NK) cells" with high dose chemotherapy and allogeneic hematopoeitic stem cell transplantation with the goal of defining the maximum tolerated dose of NK cells. The NK cells will be donated from a relative of yours who has certain genetic type in their blood called HLA, that almost matches yours. The stem cells you will receive will come from a separate HLA matched (HLA A, B, C, DR) relative or unrelated donor. The safety of this treatment will also be studied. Conditions: Myelodysplastic Syndrome, Leukemia Intervention / Treatment: DRUG: Thymoglobulin, DRUG: Busulfan, DRUG: Fludarabine, PROCEDURE: Alloreactive NK Infusion, DRUG: G-CSF, DRUG: Tacrolimus, DRUG: Methotrexate, DRUG: Interleukin-2 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: * Patients with age <= 70 years with one of of the following: Acute myeloid leukemia past first remission, in first or subsequent relapse, in second or greater remission or primary induction failure; Myelodysplastic syndromes with intermediate or high risk IPSS score; CML which has progressed to accelerated phase or blast crisis despite imatinib treatment * Patients must have an HLA matched (HLA A, B, C, DR) related or unrelated donor willing to donate for allogeneic peripheral blood progenitor cell transplantation. (Recent large analyses of the National Marrow Donor Program indicate that a mis-match at the DQ locus has no adverse effect on outcome. The current national standard of care is to consider only these 4 loci in identifying suitably "matched" donors.) * Patients must have a haploidentical relative who is predicted to be alloreactive based upon the presence of the relevant KIR genes and incompatibility with the recipient for HLA C and Bw antigens. * Zubrod performance status <= 2. * Left ventricular ejection fraction >= 45%. No uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease. * No symptomatic pulmonary disease. forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) >= 50% of expected, corrected for hemoglobin. * Serum creatinine <= 1.8mg%. * Serum glutamate pyruvate transaminase (SGPT) <= 200 IU/ml unless related to patients malignancy. * Bilirubin <= 1.5 mg/dl (unless Gilbert's syndrome).No evidence of chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Study Chairman and consider liver biopsy. * Patient or patient's legal representative, parent(s) or guardian able to sign informed consent. * No known allergy to mouse proteins or monoclonal antibodies Exclusion Criteria: * Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility. * Pleural/pericardial effusion or ascites estimated to be >1L. * HIV-positive. * Pregnancy: Positive Beta Human Chorionic Gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization. * Known allergy to mouse proteins. * Patient has received other systemic chemotherapeutic drugs (including Mylotarg) within 14 days prior to trial enrollment or has unresolved grade >1 toxicity from prior chemotherapy treatment. (Hydroxyurea or low dose ara-c less than or equal to 20 mg/m2/d is permitted if indicated to control induction refractory disease, and IT chemotherapy is allowed if indicated as maintenance treatment for previously diagnosed lumbar microdiscectomy (LMD), that is in remission prior to enrollment on this study).

Study Objectives The purpose of this study is to identify and characterize the Somatic Stem Cell (SSC) responsible for the formation and growth of leiomyomas using the Side Population method. Conditions: Leiomyomas Intervention / Treatment: GENETIC: Laparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma. Location: Spain Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Clinical diagnosis for subserosal, intramural and submucosal fibroids. * Aged between 20 and 40 years * Signing of informed consent for collection and storage of biological samples. Exclusion criteria: * Contraindications for surgery. * Failure to sign informed consent for collection and storage of biological samples.

Study Objectives This study will evaluate the role of Gemcitabine and Abraxane in the treatment of resectable and borderline-resectable pancreatic cancer by giving the chemotherapy before surgery. Conditions: Pancreatic Cancer Intervention / Treatment: DRUG: Chemotherapy, DRUG: Chemotherapy + ChemoRadiotherapy 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: * * Histologically or cytologically confirmed adenocarcinoma of the pancreas. * Patients must have locally advanced pancreatic cancer, classified as either low-risk resectable (LR), high-risk resectable (HR) or borderline resectable (BR) * Age between 18 and 90 years at the time of consent. * Patients with biliary obstruction must have adequate drainage prior to starting treatment. * Patients must have ≤ Grade I peripheral neuropathy (CTCAE v 4.0) * Patients must have ≤ ECOG Performance status 2 * Pretreatment laboratory parameters: * Absolute granulocyte/neutrophil count (AGC/ANC) ≥ 1.8 thou/mm3 * Platelet count ≥ 100,000/mm3 * Bilirubin < 2 mg/dl * ALT/SGPT < 10x upper limit of normal * Creatinine < 3 mg/dl * Calculated creatinine clearance (via Cockcroft-Gault) > 30 mL/min * Baseline CA 19-9 levels * Signed study specific, IRB stamped informed consent Exclusion Criteria: * * Evidence of any distant metastasis including peritoneal seeding and/or malignant ascites * Previous irradiation to the abdomen that would compromise the ability to deliver the prescribed treatment * Prior treatment for pancreatic cancer * Active, untreated infection * Surgical resection of the tumor (not including biopsies) * Other malignancy (except non-melanoma skin cancer) that has not been disease-free for at least 5 years. * Pregnant and/or breast-feeding women, or patients (men and women) of child-producing potential not willing to use medically acceptable contraception while on treatment and for at least 3 months thereafter. * Use of anti-epileptics (drugs such as phenytoin, phenobarbitol and carbamazepine) * ECG abnormality with the following: QTC >500, left bundle branch block or any other clinically significant finding that would interfere with protocol therapy. * History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician

Study Objectives Dual-energy CT (DECT) provides information on the blood volume in tumors and lymph nodes. As tumors respond to treatment, preliminary data suggests that the blood volumes changes as well. Investigators are therefore using DECT to test whether it can be used on radiation treatment to rapidly assess response to treatment. Conditions: Non-small Cell Lung Cancer Stage III Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients aged greater than 18 years with a diagnosis of stage III non-small cell lung cancer. * Planned treatment with either definitive chemoradiotherapy or preoperative chemoradiotherapy followed by surgical resection. * PET-CT study within 4 weeks of next available DECT study. * Patients must have measurable primary and nodal disease, defined by at least one lesion (primary and lymph node) greater than 1 cm. * Kidney function sufficient to tolerate iodine-based CT contrast. * No allergy to iodine-based contrast. * Ability to understand and the willingness to sign informed consent. Exclusion Criteria: * Participants with a prior history of thoracic radiotherapy. * Participants may not be receiving any other study agents. * Inability to tolerate CT contrast * Pregnant women are excluded from this study because radiotherapy has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with radiotherapy, breastfeeding should be discontinued if the mother is treated with radiotherapy. These potential risks may also apply to other agents used in this study.

Study Objectives Phase Ib / II study to determine the Maximum Tolerated Dose and Recommended Phase II Dose, and to evaluate the safety and antitumour activity, of BI 836845 and everolimus in combination with exemestane in women with HR+/HER2- advanced breast cancer Conditions: Neoplasms Intervention / Treatment: DRUG: Everolimus, DRUG: Everolimus, DRUG: Everolimus, DRUG: Exemestane, DRUG: BI 836845, DRUG: BI 836845, DRUG: Exemestane, DRUG: Exemestane Location: Spain, Ireland, France, Belgium, Netherlands, Taiwan, Austria, United Kingdom, Sweden, Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion criteria: * Histologically-confirmed locally advanced (aBC) or metastatic breast cancer (mBC) not deemed amenable to curative surgery or curative radiation therapy * Tumors are positive for estrogen-receptor (ER) and/or progesterone receptor (PgR). * Tumors must be negative for HER2 per local lab testing. * Must have adequate archival tumor tissue from surgery or biopsy. * Postmenopausal female patients aged >=18 years old. * Objective evidence of recurrence or progressive disease on or after the last line of systemic therapy for breast cancer prior to study entry * The patient is disease refractory to non-steroidal aromatase inhibitor (letrozole and/or anastrozole) * Patients must have: a) Measurable lesion according to RECIST version 1.1 (R09-0262) or b) Bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable lesion as defined above * Eastern Cooperative Oncology Group performance score <= 2. * Life expectancy of >= 6 months in the opinion of the investigator * Fasting plasma glucose < 8.9 mmol/L (< 160 mg/dL) and HbA1c < 8.0% * Adequate organ function * Recovered from any previous therapy related toxicity to <= Grade 1 at study entry (except for stable sensory neuropathy <=Grade 2 and alopecia) * Written informed consent that is consistent with ICH-GCP guidelines and local regulations Inclusion criteria for the biopsy substudy are identical to the main study of the phase II part except for the following two inclusion criteria: * Fresh tumor biopsy should be taken when deemed safe and feasible by the investigator and upon informed consent by the patient. Bone lesion is not recommended for biopsy * Patients eligible to undergo tumor biopsy should have normal coagulation parameters (INR and PTT within normal range) Exclusion criteria: * Previous treatment with agents targeting on IGF pathway, phosphoinositide 3-kinase (PI3K) signaling pathway, protein kinase B (AKT), or mammalian target of rapamycin (mTOR) pathways * Prior treatment with exemestane (except adjuvant exemestane stopped >12 months prior to start of study treatment as long as the patient did not recur during or within 12 months after the end of adjuvant exemestane) * Known hypersensitivity to monoclonal antibody, mTOR inhibitors (e.g. sirolimus), or to the excipients of any study drugs * Ovarian suppression by ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist * Less than one week after receiving immunization with attenuated live vaccines prior to study treatment * Radiotherapy within 4 weeks prior to the start of the study treatment, except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within two weeks prior to study treatment * Chemotherapy, biological therapy (other than bevacizumab), immunotherapy or investigational agents within 5 half-life of the drug or within two weeks prior to the start of study treatment, whichever is longer; bevacizumab treatment within 4 weeks prior to start of study treatment (this criterion concerns anti-cancer therapy only) * Hormonal treatment for breast cancer within 2 weeks prior to start of study treatment * Major surgery in the judgement of the investigator within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study * Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use except Topical applications, inhaled sprays, eye drops or local injections or Patients on stable low dose of corticosteroids for at least two weeks before study entry * Chronic hepatitis B infection, chronic hepatitis C infection and/or known HIV carrier * QTcF prolongation > 470 ms or QT prolongation deemed clinically relevant by the investigator * Disease that is considered by the investigator to be rapidly progressing or life threatening such as extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor * History or current presence of brain or other CNS metastases * Bilateral diffuse lymphangitic carcinomatosis (in lung) * Hypokalemia of Grade >1 * History of another primary malignancy within 5 years, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer * Family history of long QT syndrome * Any concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety and anti-tumor activity of the test drug(s) * Patients being treated with drugs recognized being strong or moderate CYP3A4 and/or PgP inhibitors and/or strong CYP3A4 inducers within 2 weeks prior to study entry * Patients received more than two lines of chemotherapy for locally advanced or metastatic breast cancer (For the Phase II: more than one line)

Study Objectives Open-label, multicenter study of imatinib (400mg/die p.o.)in patients with advanced gastrointestinal stromal tumors. Patients will be treated for up to 12 months. Data regarding its best clinical use in terms of tumor response, survival, tolerability and safety profile will be prospectively collected. Conditions: Advanced Gastrointestinal Stromal Tumors Intervention / Treatment: DRUG: Imatinib Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients ≥ 18 years of age. * Histologically documented diagnosis of GIST, unresectable and/or metastatic and therefore incurable with any conventional multimodality approach. * Immunohistochemical documentation of c-kit (CD117) expression by tumor, as detected on a tumor sample taken within 6 weeks of study entry. * At least one measurable site of disease (RECIST Criteria), or other response assessment criteria, as appropriate. * Performance status 0,1, 2 or 3 (ECOG). * Adequate end organ function. * Adequate bone marrow function. * Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Exclusion Criteria: * Previous treatment with any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing. * Other primary malignancy with < 5 years clinically assessed disease free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged after consultation with the Steering committee to entail a low risk of relapse. * Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. * Pregnancy, breast-feeding. * Severe and/or uncontrolled medical disease. * Known brain metastasis. * Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis). * Known diagnosis of human immunodeficiency virus (HIV) infection. * Previous treatment with chemotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin-C). * Previous radiotherapy to ≥ 25 % of the bone marrow. * Major surgery within 2 weeks prior to study entry.

Study Objectives Aim: to investigate the effect of a high inspiratory oxygen fraction (FiO2) given during and after laparotomy procedures on occurrence of a subsequent, new or recurrent, cancer diagnosis at a long-term follow-up. Background: A high inspiratory oxygen fraction (FiO2 = 0.80) has been linked to prevention of surgical site infection, but the Danish randomized clinical multicenter trial, the PROXI trial, found no difference in frequency of surgical site infection. In fact, long-term mortality was significantly increased with a hazards ratio of 1.30 in patients receiving 80% oxygen, and this appeared to be statistically significant in patients undergoing cancer surgery, but not in non-cancer patients. At this point, no convincing mechanism explains the observed increased mortality after hyperoxia, as the long-term pathophysiological effects of oxygen are not fully understood. Primary hypothesis of this follow-up study of the PROXI trial: Use of 80% oxygen increase the frequency of patients with a subsequent, new or recurrent, cancer. Conditions: Laparotomy Intervention / Treatment: DRUG: Oxygen Location: Denmark Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Age 18 years or older. * Laparotomy, acute or elective. In case of gynaecological surgery only if malignancy is suspected (defined as risk of ovarian malignancy index >200 or a specimen with atypical or neoplastic cells). Exclusion Criteria: * Other surgery within 30 days (except surgery in local anaesthesia). * Chemotherapy within 3 months. * Inability to give informed consent. * Inability to keep oxygen saturation above 90% without supplemental oxygen (measured preoperatively by pulse oximetry).

Study Objectives "Several case reports have described the use of rocuronium and sugammadex in patients with myasthenia gravis (MG). However, reports regarding the effects of sugammadex compared with that of acetylcholinesterase inhibitors (AChEIs) on perioperative outcomes of video-assisted thoracoscopic surgery (VATS)-thymectomy in patients with MG are still lacking. Thus, the investigators will investigate the effects of sugammadex compared to AChEIs on the postoperative recovery in patients with MG who underwent VATS-thymectomy. This retrospective study include patients with MG, aged\> 18 years who received sugammadex or pyridostigmine-glycopyrrolate or neostigmine-glycopyrrolate after VATS-thymectomy between November 2007 and December 2020. Inverse Probability of Treatment Weighting (IPTW) adjustment will be performed to balance the baseline characteristics between the two groups. The primary outcome is the length of postoperative hospital stay, and the secondary outcomes are the incidence of postoperative mortality and postoperative complications, as well as postoperative extubation and reintubation rates in the operating room after VATS-thymectomy; the outcomes are compared between the two groups. " Conditions: Myasthenia Gravis Location: Korea, Republic of Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * patients underwent VATS-thymectomy between November 2007 and December 2020 Exclusion Criteria: * Patients who was not diagnosed with myasthenia gravis * Age ≤ 18 * Patients for which no reversal agent was used

Study Objectives In this retrospective study, we analyzed data from the Sichuan Cancer Hospital \& Institute Esophageal Cancer Case Management Database (SCH-ECCM Database) from January 2010 to December 2017. Our study focused on examining the clinicopathological characteristics, lymph node removal at each station, and treatment details of patients with esophageal squamous cell carcinoma (ESCC) who underwent esophagectomy. Using this data, we developed a prediction model for OS by considering a combination of clinical characteristics and details of lymphadenectomy variables. Conditions: Survivorship Intervention / Treatment: OTHER: This was an observational study without any intervention Location: China Study Design and Phases Study Type: OBSERVATIONAL

Inclusion criteria: * Patients underwent esophagectomy at our hospital. Exclusion criteria: * pathology confirmed a non-squamous cell carcinoma, * the tumor was located outside of the thoracic region, * R1/R2 resection was performed indicating incomplete tumor removal, * evidence of distant tumor metastasis was observed, or * they underwent preoperative neoadjuvant therapy

Study Objectives Investigate the safety and tolerability of ramucirumab (IMC-1121B) drug product (DP) in combination with paclitaxel. Conditions: Adenocarcinoma Intervention / Treatment: BIOLOGICAL: Ramucirumab (IMC-1121B ), DRUG: Paclitaxel Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Has a histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma * Has an advanced or metastatic solid gastric adenocarcinoma that has failed standard therapy * Has resolution of all clinically significant toxic effects of prior therapy, surgery, treatment with an investigational agent or device, treatment monoclonal antibody or small molecule, and radiotherapy or chemotherapy. * Has adequate organ function * Eligible participants of reproductive potential (both sexes) agree to use adequate contraceptive methods (hormonal or barrier methods) during the study period and for 12 weeks after the last dose of study medication Exclusion Criteria: * Has undergone major surgery within 28 days prior to the study, or subcutaneous venous access device placement within 7 days prior to the study registration date * Has elective or planned surgery to be conducted during the trial * Has had treatment with an investigational agent or device, an antineoplastic small molecule, or antineoplastic radiotherapy or chemotherapy * Was previously treated with a chemotherapy regimen containing nitrosoureas or mitomycin C * Has had treatment with an antineoplastic monoclonal antibody within 8 weeks prior to the study registration date * Has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism prior to the study registration date * Has experienced any arterial thrombotic event, including myocardial infarction, cerebrovascular accident, or transient ischemic attack, within 6 months prior to the study date * Is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin or similar agents. (Participants receiving prophylactic, low-dose anticoagulation therapy are eligible provided that the coagulation parameters International Normalized Ratio (INR) ≤ 1.5, prothrombin time (PT) and partial thromboplastin time (PTT) or - Is receiving chronic therapy with nonsteroidal anti-inflammatory agents \[Aspirin use at doses up to 325 milligrams/day (mg/day) is permitted\] * Has significant bleeding disorders, vasculitis, history of postoperative bleeding complications, hemoptysis or had a significant bleeding episode from the gastrointestinal (GI) tract within 3 months prior to the study date * Has a history of GI perforation and/or fistulae within 6 months prior to the study date * Has symptomatic congestive heart failure, unstable angina pectoris, or symptomatic or poorly controlled cardiac arrhythmia * Has uncontrolled arterial hypertension despite standard medical management. * Has a serious or nonhealing wound or peptic ulcer or bone fracture within 28 days prior to the study date * Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhea * Has a serious illness or medical condition(s) * Is pregnant or lactating * Has received treatment with another investigational drug or participation in another interventional clinical trial within 28 days prior to the study date

Study Objectives This protocol will examine the safety of intratumoral administration of Clostridium Novyi-NT spores in patients with treatment-refractory solid tumor malignancies. This investigational study will measure anti-tumor activity of C. novyi-NT administered intratumoral in patients with treatment-refractory solid tumor malignancies. Conditions: Solid Tumor Malignancies Intervention / Treatment: BIOLOGICAL: Clostridium novyi-NT spores 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: * Diagnosis of an advanced solid tumor malignancy. There must be a target tumor which is measureable, palpable or clearly identifiable under ultrasound or radiographic guidance and amenable to percutaneous injection of C. novyi-NT spores. The targeted lesion must have a longest diameter ≥ 1 cm and ≤ 12 cm and be measurable as defined by RECIST 1.1 criteria. The target lesion must not be located in either the thoracic, abdominal or pelvic cavities or in the brain. There must be no clinical, no functional, and no radiographic evidence of bone involvement at the site of the target lesion. * History of prior treatment with at least one line of systemic anticancer therapy, when an approved systemic therapy is available, and no curative option is available for continued treatment. * At least 4 weeks have elapsed since the completion of major surgery, and the patient has fully recovered from this surgery and any post-surgical complications. * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. * Patient is at least 18 years of age. * Patient is capable of giving informed consent. * Patient of childbearing potential (defined by the clinical sites' standards) is using adequate birth control measures (e.g., barrier method with spermicide; intrauterine device; implantable or injectable hormonal contraceptives; surgical sterilization) for the duration of the study and will continue to use such precautions for 12 months after receiving treatment. * Patient has no significant valvular heart disease (trace or mild valvular stenosis or regurgitation is allowed). * Patient is able to stay within 45 minutes driving time of an emergency room for 28 days after doing. * The patient has a caregiver for 28 days after dosing. Exclusion Criteria: * Positive pregnancy test. * Serum creatinine level > 1.5 x the upper limit of normal (ULN), chronic renal failure requiring hemodialysis or peritoneal dialysis. * Patient has any of the following hematologic parameters: * Platelet count equal to or less than 100,000/mm3 * Hemoglobin less than 9.0 g/dL * Absolute neutrophil count (ANC) less than 1,000 /mm3 * Oxygen saturation (Sp02) of less than 95% on room air. * Mean arterial blood pressure (BP) of less than 70 mmHg. * Glasgow Coma Score (GCS) of less than 15. * Treatment with an investigational drug within the past 30 days or 5 half-lives of that drug, whichever is shorter. * Documented primary brain malignancy or brain metastases. * Clinically significant ascites or clinical evidence or history of portosystemic hypertension or cirrhosis. * Laboratory evidence of hepatic dysfunction indicated by any of the following: * Bilirubin ≥ 1.5 x the ULN * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) above 2.5X the ULN * Alkaline phosphatase above 2.5X the ULN * International normalized ratio (INR) greater than 1.3 * Patient has a foreign body which in the opinion of the treating investigator could be difficult to manage in case of infection (e.g. prosthetic hip). * Clinically significant pleural effusion. * Clinically significant pericardial effusion, circumferential pericardial effusion, or any effusion greater than 1.0 cm at any location around the heart. * Need for ongoing treatment with an immunosuppressive agent. * History of solid organ transplantation (with the exception of a corneal transplant > 3 months prior to screening). * History of an ischemic insult in the previous 12 months (myocardial infarction, cerebral vascular accident, ischemic tissue from injury, transient ischemic attack. * History of a significant medical illness deemed by the PI or local investigators as unsuitable for the trial. For example: i. Symptomatic congestive heart failure ii. Psychiatric Illness/social situation that may make study dangerous iii. Unstable angina pectoris * Asplenia. * Antibiotic allergies that would preclude treatment for a C. novyi-NT infection. * Treatment with antibiotics within 2 weeks (14 days) of dosing. * Active and clinically significant systemic or localized infection.

Study Objectives Postoperative infections are one of the most common complications in thoracic and digestive cancer surgery. Former studies have demonstrated that inflammatory response is altered during peri-operative period causing lymphopenia. It has been suggested that lymphopenia may contribute to postoperative infection. To date, no one has proved it in a multivariate analysis. The aim of this study is to determine if lymphopenia is associated with postoperative infections in thoracic and digestive cancer surgery. Conditions: Cancer of the Digestive System, Thoracic Diseases Intervention / Treatment: OTHER: Collection of plasma cell rate Location: France Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * patient undergoing digestive or thoracic cancer surgery under general anesthesia. Exclusion Criteria: * pregnant women, * malignant blood disease, * allograft patient, * preoperative sepsis or preoperative systemic inflammatory response syndrome.

Study Objectives The main objective of the trial is to document the efficacy of NGR-hTNF administered at low dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a pemetrexed-based chemotherapy regimen. Conditions: Malignant Pleural Mesothelioma Intervention / Treatment: DRUG: NGR-hTNF plus Best Investigator's Choice (BIC), DRUG: Placebo plus Best Investigator's Choice (BIC) Location: Spain, United States, Ireland, Italy, France, Canada, Belgium, Netherlands, Poland, Egypt, United Kingdom, Sweden Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Age ≥ 18 years * Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatoid, mixed, or unknown * Prior treatment with no more than one systemic pemetrexed-based chemotherapy regimen administered for advanced or metastatic disease. Prior use of a biological agent in combination with a pemetrexed-based regimen and prior administration of intrapleural cytotoxic agents are allowed. Patients who have previously received anthracyclines should not receive doxorubicin * ECOG Performance Status 0 - 2 * Life expectancy of ≥ 12 weeks * Adequate baseline bone marrow, hepatic and renal function, defined as follows: 1. Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL 2. Bilirubin ≤ 1.5 x ULN 3. AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in presence of liver metastasis 4. Serum creatinine < 1.5 x ULN * Measurable or non-measurable disease according to MPM-modified RECIST criteria * Patients may have had prior therapy providing the following conditions are met: 1. Surgery: wash-out period of 14 days 2. Systemic and radiation anti-tumor therapy: wash-out period of 28 days * Patients must give written informed consent to participate in the study Exclusion Criteria: * Patients must not receive any other investigational agents while on study * Patients with myocardial infarction within the last six months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication * Uncontrolled hypertension * QTc interval (congenital or acquired) > 450 ms * History or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy, or history of stroke) * Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol * Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol * Pregnancy or lactation

Study Objectives Prospective double blind randomized evaluation of the effect of surgical wound infiltration with ropivacaine versus placebo in patients scheduled for breast surgery with axillary lymph node dissection Conditions: Breast Cancer Intervention / Treatment: PROCEDURE: infiltration with ropivacaine solution Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Adult ASA I - II patients, scheduled for unilateral mastectomy or tumorectomy associated with axillary lymph node dissection Exclusion Criteria: * Patients receiving opioid or any other analgesic treatment for chronic pain before surgery, patients with known allergy to local anaesthetics, and patients with acquired or genetic haemostatic abnormality