araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Side Population in Pancreatic Ductal Adenocarcinoma (PDAC)

Summary: In the current project we aim to study the oncological process of pancreatic cancer, from a perspective of the CSC-theory and in particular through the 'side population' (SP)-approach. The SP seems to be enriched for CSC and doesn't a priori exclude any CSC-subpopulation. After isolation from pancreatic cancer resection specimens, SP cells will be characterized by gene-expression profiling based on microarray analysis. We'll identify markers and pathways (with emphasis for stem cell and cancer -related ones) that are differentially expressed in SP versus the rest of tumour cells (the 'main population' or MP). In order to assess the prognostic relevance of the SP, we'll study these genes using the high-throughput Nanostring technology in about 200 snap-frozen PDAC resection specimens of patients from our prospective database. Finally, two monoclonal antibodies (mAB) will be tested as novel therapeutic agents in vivo (mouse model), wherein the choice of mAB will be based on prognostically relevant molecular targets and pathways obtained from the Nanostring results.


Eligibility: Inclusion Criteria:
  -  Resected pancreatic ductal adenocarcinoma (PDAC)
  -  Informed consent
  Exclusion Criteria:
  -  Age < 18years
  -  Pregnancy
  -  Pre-operative radiotherapy
  -  Pre-operative chemotherapy
  -  IPMT

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Influence of Gemcitabine Treatment on Immunological and Serological Profile in Patients With Pancreatic Cancer

Summary: Observational study of influence of gemcitabine treatment on serological and immunological status and gene expression profile in patients with pancreatic tubular carcinoma after tumor resection.


Eligibility: Inclusion Criteria:
  -  ECOG performance status 0-2 at the time of inclusion
  -  Following R0 or R1 pancreatic tubular adenocarcinoma resection
  Exclusion Criteria:
  -  Pregnancy
  -  Serious comorbidity

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Epidemiologic Study of KRAS Mutation in Brazilian Patients With Advanced or Metastatic Non Small Cell Lung Cancer

Summary: The purpose of this study is to characterize the demographic and clinical aspects, and describe the frequency and type of KRAS mutation in a Brazilian population sample with advanced non-small cell lung cancer (NSCLC).


Eligibility: Inclusion Criteria:
  -  Histological or cytological confirmation of locally advanced or metastatic Non Small Cell Lung Cancer (IIIB-IV)
  -  Tumour sample (block of slides) available for KRAS analysis
  Exclusion Criteria:
  -  Confirmation of locally advanced or metastatic NSCLC (IIIB-IV) exclusively by cytology, with no tumour sample access.
  -  Previous treatment using a MEK inhibitor or any other regimen containing docetaxel (previous treatment with paclitaxel is accepted)

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Mitomycin C and Ifosfamide in Treating Patients With Metastatic Pancreatic Cancer

Summary: RATIONALE: Drugs used in chemotherapy, such as mitomycin C and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
  PURPOSE: This phase II trial is studying how well giving mitomycin C together with ifosfamide works in treating patients with metastatic pancreatic cancer.

Detailed description: OBJECTIVES:
  -  To assess the therapeutic activity of a mitomycin C and ifosfamide combination, in terms of progression-free survival rate at 6 months, in patients with metastatic stage IV adenocarcinoma of the pancreas.
  OUTLINE: Patients receive mitomycin C IV on day 1 and ifosfamide IV on days 1-3. Courses repeat every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed adenocarcinoma of the pancreas
  -  Stage IV disease
  -  Metastatic disease
  -  Prior treatment with gemcitabine-based chemotherapy, also in the adjuvant setting, with progression-free survival at ≤ 12 months
  -  Measurable disease according RECIST criteria
  -  No symptomatic brain metastases
  PATIENT CHARACTERISTICS:
  -  Karnofsky performance status 60-100% (80-100% in patients > 70 years of age)
  -  Adequate bone marrow, liver, and kidney function
  -  Not pregnant or nursing
  -  No other prior or concurrent malignancies except surgically cured carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, or other neoplasms with no evidence of disease ≥ 5 years
  -  No severe comorbidities that could compromise safety, including any of the following:
  -  Cardiac failure
  -  Cardiac arrhythmia
  -  Prior myocardial infarction within the past 4 months
  -  History of psychiatric disabilities
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No prior mitomycin C and ifosfamide
  -  No concurrent treatment with experimental drugs

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Preoperative Panitumumab and Radiotherapy in Rectal Cancer

Summary: The purpose of this study is to investigate the activity of panitumumab in combination with standard preoperative radiotherapy in locally advanced rectal cancer, followed by complete surgery and adjuvant chemotherapy.
  The main hypothesis of the study is that the association of EGFR-targeting agent and radiation therapy could be as effective or even improve the rate of pathological complete tumoral response with fewer toxicities in comparison to the standard of care using chemoradiation therapy.

Detailed description: Anti-EGFR monoclonal antibodies have radiosensitizing properties. In particular, cetuximab in combination with curative-intent radiotherapy has been reported to increase median overall survival over radiation therapy alone in locally advanced head and neck carcinoma.
  Similar benefit in rectal cancer is expected. However, preliminary studies revealed that the combination of chemoradiation and cetuximab did not seem to improve the pathological tumor response. However, in the past studies, the selection of patients' population was not optimal since KRAS mutational status was not considered during recruitments.
  Therefore, new trials to investigate EGFR-targeting therapies in combination with radiotherapy in wild-type KRAS patients are required.
  Adjuvant chemotherapy has also shown to decrease the risk of local relapse in patients who did not receive chemotherapy during radiotherapy. In our study, since there will be no chemotherapy given during the preoperative setting, the administration of adjuvant chemotherapy postoperatively is highly recommended.

Eligibility: Inclusion Criteria:
  -  ECOG Performance Status 0-1
  -  Histologically proven adenocarcinoma of the rectum, T3-T4 and/or N+ M0
  -  Wild-type KRAS
  -  No prior pelvic irradiation
  -  Normal bone marrow, hepatic, renal, cardiac functions
  -  No secondary malignancy
  -  No other active, uncontrolled disease
  -  Signed informed consent
  Exclusion Criteria:
  -  KRAS mutation
  -  Established or suspected metastasis
  -  Prior pelvic irradiation
  -  Previous exposure to EGFR-targeting therapies
  -  Patients under any other investigational agent(s)
  -  Concurrent systemic immune therapy, chemotherapy, hormone therapy
  -  Drug and/or alcohol abuse
  -  Grade 3 to 4 allergic reaction to any of the components of the treatment
  -  History or presence of interstitial lung disease
  -  Active, uncontrolled cardiovascular disease

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Safety, Tolerability and Pharmacokinetics of Cobimetinib in Combination With Pictilisib in Patients With Locally Advanced or Metastatic Solid Tumors

Summary: This is an open-label, multicenter, Phase Ib dose-escalation study designed to assess the safety, tolerability and pharmacokinetics of oral dosing of cobimetinib and pictilisib administered in combination in patients with locally advanced or metastatic solid tumors.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically documented, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable
  -  Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)
  -  Life expectancy greater than or equal to (>=) 12 weeks
  -  Adequate hematologic and end organ function
  -  Agreement to use an effective form of contraception for the duration of the study
  Exclusion Criteria:
  -  History of prior significant toxicity from another mitogen-activated protein kinase (MEK) pathway inhibitor requiring discontinuation of treatment
  -  History of prior significant toxicity from another phosphoinositide 3-kinase (PI3K) pathway inhibitor requiring discontinuation of treatment
  -  Allergy or hypersensitivity to components of the cobimetinib or pictilisib formulations
  -  Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in Cycle 1
  -  Experimental therapy within 4 weeks prior to first dose of study drug treatment in Cycle 1
  -  Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug treatment in Cycle 1, or anticipation of the need for major surgery during the course of study treatment
  -  Prior anti-cancer therapy within 28 days before the first dose of study drug treatment in Cycle 1
  -  History of diabetes requiring daily medication, or history of Grade >= 3 fasting hyperglycemia
  -  Current severe, uncontrolled systemic disease
  -  History of clinically significant cardiac or pulmonary dysfunction
  -  History of malabsorption or other condition that would interfere with enteral absorption
  -  Clinically significant history of liver disease (including cirrhosis), current alcohol abuse, or current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
  -  Any condition requiring anticoagulants, such as warfarin, heparin, or thrombolytics
  -  Active autoimmune disease
  -  Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment
  -  Pregnancy, lactation, or breastfeeding
  -  Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
  -  No other history of or ongoing malignancy that would potentially interfere with the interpretation of the pharmacodynamic or efficacy assays

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer

Summary: This is a phase 1b study to evaluate the combination of gemcitabine and Tarceva (erlotinib) and nab-paclitaxel in patients with advanced pancreatic cancer.

Detailed description: This is a single-arm, phase 1b study to determine the maximum tolerated dose (MTD) of the combination of erlotinib (daily), gemcitabine (weekly), nab-paclitaxel (weekly) in patients with advanced pancreatic cancer.

Eligibility: Inclusion Criteria:
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
  -  Predicted life expectancy of >= 12 weeks
  -  Previous surgery
  -  Histologically or cytologically confirmed, measurable, locally advanced, unresectable or metastatic pancreatic adenocarcinoma
  -  No prior therapy for pancreatic cancer
  -  Adequate organ and marrow function
  -  Absolute neutrophil count >= 1.5 x 10^9/L
  -  Platelets >= 100 x 10^9/L
  -  Total bilirubin <= institutional upper limits of normal
  -  AST (SGOT)/ALT(SGPT) <= 2 x institutional upper limits of normal
  -  Serum creatinine <= 1.5 x upper limits of normal
  -  Negative pregnancy test
  -  Informed consent
  -  Patient must agree not to smoke while on study
  Exclusion Criteria:
  -  Significant history of cardiac disease unless the disease is well controlled
  -  Active or uncontrolled infections or serious illness or medical conditions that could interfere with the patient's ongoing participation in study
  -  History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent
  -  History of smoking within the previous 14 days before enrollment or positive cotinine test at baseline
  -  Pregnant or breast-feeding females
  -  Symptomatic brain metastases that are not stable, that require steroids, that are potentially life-threatening, or that have required radiation within the last 14 days
  -  History of allergic reactions attributed to compounds of similar chemical or biological composition to the study drugs

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Modulation of the Immune Response in Patients With Pancreatic Tubular Adenocarcinoma

Summary: Interventional study of modulation of immune response in patients with pancreatic tubular adenocarcinoma after resection and gemcitabine treatment. When included, patients are pre-treated with moderate doses of cyclophosphamide. Then infusions of allogeneic mononuclear cells are given.


Eligibility: Inclusion Criteria:
  -  ECOG performance status 0-2 at the time of inclusion
  -  Following R0 or R1 pancreatic tubular adenocarcinoma resection and adjuvant gemcitabine treatment
  Exclusion Criteria:
  -  Pregnancy
  -  Less than 3 mths expected survival
  -  Serious comorbidity
  -  Age above 70 yrs

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: A Study to Assess the Efficacy and Safety of Lenalidomide in Combination With Cetuximab in Pre-treated Patients With KRAS Mutant Colorectal Cancer

Summary: The purpose of this study is to determine whether lenalidomide in combination with cetuximab is safe and effective in patients with KRAS mutant colorectal cancer.


Eligibility: Inclusion Criteria:
  1. Metastatic colorectal adenocarcinoma.
  2. Confirmed K-RAS mutant tumor
  3. Disease progression on oxaliplatin- AND irinotecan-containing regimens, with at least one of these regimens containing bevacizumab.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
  Exclusion Criteria:
  1. Use of chemotherapy, hormonal therapy, immunotherapy or any other cancer or experimental treatment ≤ 28 days prior to the first day of the first cycle.
  2. Radiotherapy for up to ≥ 30% of the bone marrow.
  3. Surgery ≤ 28 days before day 1 of the first cycle (minimally invasive interventions for diagnostic purposes or disease staging are permitted).
  4. Previous treatment with cetuximab, panitumumab, pomalidomide (CC-4047), lenalidomide or thalidomide.
  5. Untreated, symptomatic brain metastases (brain imaging not required).
  6. Venous thromboembolism ≤ 6 months before day1 of the first cycle.
  7. Current congestive heart failure (classes II to IV of the New York Heart Association).
  8. Myocardial infarction ≤ 12 months before day1 of the first cycle.
  9. Uncontrolled hypertension.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Safety Study of Adjuvant Gemcitabine Started One Week After Laparoscopic Distal Pancreatectomy for Adenocarcinoma

Summary: We believe that laparoscopic distal pancreatectomy for cancer allows quicker recovery and significantly reduces the chances of postoperative wound breakdown. This will shorten the wait time required to begin adjuvant therapy to one week after surgery thereby combating the micrometastasis unseen at the time of surgery. Prognosis for patients with pancreatic cancer will therefore improve along with decreasing the incidence of locoregional recurrence.

Detailed description: Gemcitabine-based chemo¬therapy remains the cornerstone for treatment of locally advanced or metastatic pancreatic cancer. Other novel chemotherapeutic combinations have been investigated in clinical trials, but the overall conclusions are that these agents have failed to improve outcomes. Our hypothesis is that nodal and hematologic micrometastasis make pancreas cancer a systemic problem at the time of surgery. Waiting the traditional six weeks to begin adjuvant therapy allows this very aggressive cancer to metastasize while the patient is waiting to begin therapy. This leads to the increased incidence of locoregional recurrence and poor prognosis. We believe that laparoscopic distal pancreatectomy for cancer allows quicker recovery and significantly reduces the chances of postoperative wound breakdown. This will shorten the wait time required to begin adjuvant therapy to one week after surgery thereby combating the micrometastasis unseen at the time of surgery. Prognosis for patients with pancreatic cancer will therefore improve along with decreasing the incidence of locoregional recurrence.
  Methods: We will perform a prospective, non-randomized phase II study with patients undergoing laparoscopic distal pancreatectomy for pancreatic adenocarcinoma at Johns Hopkins Hospital. Gemcitabine will be given as a single-agent chemotherapy regimen one week following laparoscopic distal pancreatectomy according to the protocol designed by our medical oncologist. Six cycles of gemcitabine will be given. The patients will be followed in the medical oncology clinic weekly. Our Primary outcome variable will be all cause postoperative morbidity. Our sample size will be small (6-10 patients) as this is a Phase II study. Early termination rules include development of prohibitive toxicity or death. Our endpoints are an improvement in overall survival, quality of life, progression free survival, or disease free survival. Exclusion criteria will include patients with T4 or M1 disease, R2 resection margin, preoperative therapy, or if adjuvant therapy status was unknown.

Eligibility: Inclusion Criteria:
  -  Male or female patients older than 18 with clinical diagnosis of distal pancreas adenocarcinoma
  Exclusion Criteria:
  -  Patients with T4 or M1 disease, R2 resection margin, preoperative therapy, or if adjuvant therapy status was unknown.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: A Study to Evaluate [18F]-FDG PET (Fluorodeoxyglucose-positron) in Patients With Pancreatic Cancer (MK-0000-144)

Summary: This study will determine whether [18F]-fluorodeoxyglucose-positron emission tomography (FDG-PET) can be used to screen for the activity of novel pancreatic cancer treatments.


Eligibility: Inclusion Criteria:
  -  Patient has a diagnosis of Stage IV pancreatic adenocarcinoma with distant metastases
  -  Patient is scheduled to receive standard chemotherapy containing gemcitabine
  -  Patient has not received prior systemic therapy for advanced pancreatic adenocarcinoma
  -  Patient must be available for periodic blood sampling, study-related assessments, and management at the treating institution
  Exclusion Criteria:
  -  Patient has had open abdominal surgery within 6 weeks of the screening visit
  -  Patient has had radiotherapy to the thorax, abdomen, or pelvis within 6 months of the screening visit
  -  Patient has an active infection, inflammation, or unresolved bowel obstruction
  -  Patient has poorly controlled diabetes

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: A Study to Demonstrate the Safety and Preliminary Efficacy of 18F-FLT in Patients With Solid Tumours or Lymphoma

Summary: The Radiotracer 18F-FLT can non-invasively assess excessive cell growth in PET scan images. Tumour growth rate is a useful indicator of tumour aggression and response to treatment. Imaging and measuring the cell growth with 18F-FLT may be useful in monitoring response to anticancer treatment.

Detailed description: Clinical trial is a combined Phase I/II imaging, open label, single site study in patients with known or suspected carcinoma of the lung, breast, renal cell, pancreas or brain, and with gastrointestinal malignancies, neuroendocrine tumours, or lymphoma. One 18F-FLT PET scan will be performed in 10 Phase I patients, and pre-injection and post-imaging blood work and vital signs will be collected. Up to 5 18F-FLT PET scans will be performed in 170 Phase II patients.

Eligibility: Inclusion Criteria:
  -  Male or female greater than or equal to 16 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of last menstrual period, a negative pregnancy test is required.
  -  Patients with known primary or suspected primary, recurrent or metastatic carcinoma of the lung, breast, renal cell, pancreas or brain (including GGM, oligodendrogliomas, and brain metastases from any primary tumour) and with gastrointestinal malignancies, neuroendocrine tumours (including carcinoid and islet cell malignancies, or lymphoma, with at least one lesion >1 cm in diameter.
  -  Biochemical parameters as measured are required to be within 5 times the normal limits for age.
  -  Able and willing to follow instruction and comply with the protocol
  -  Provide written informed consent prior to participation in the study
  -  Karnofsky Performance Scale Score 50-100
  Exclusion Criteria:
  -  Previous removal of entire tumour
  -  Biochemical parameters as measured outside 5 times the normal limits for age
  -  Unable or unwilling to follow instructions and comply with the protocol
  -  Unable or unwilling to provide written informed consent prior to participation in the study
  -  Karnofsky Performance Scale Score < 50
  -  Nursing or pregnant females
  -  Age less than 16 years

Relevance to patient case: not relevant