araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Safety and Tolerability Study of GSK1120212, a MEK Inhibitor, in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel

Summary: The purpose of this study is to determine what dose of GSK1120212 can be given safely in combination with at least one other drug that is already approved to treat cancer. This study will test the safety of up to 6 different GSK1120212 study treatment combinations (GSK1120212 plus either docetaxel, erlotinib, pemetrexed, pemetrexed + carboplatin, pemetrexed + cisplatin, or nab-paclitaxel). The doses identified in this study may be used in future trials to test whether the combination treatment is a safe and effective therapy for subjects with metastatic lung and/or pancreatic cancers.


Eligibility: Inclusion Criteria:
  -  The subject has a solid tumor. Expansion cohorts are limited to non-small cell lung cancer and/or pancreatic cancer with or without a KRAS mutation.
  -  Tumor progression following at least one prior standard therapy, the subject refuses standard therapy, or no standard therapy exists.
  -  The subject has a radiographically measurable tumor.
  -  The subject is able to carry out daily life activities without difficulty.
  -  The subject is able to swallow and retain oral medication.
  -  The subject does not have significant side effects from previous anti-cancer treatment.
  -  The subject has adequate organ and blood cell counts.
  -  Sexually active subjects must use medically acceptable methods of contraception during the course of the study.
  Exclusion Criteria:
  -  The subject has had major surgery or received certain types of cancer therapy within 2-3 weeks before starting the study.
  -  The subject has a brain tumor.
  -  Current severe, uncontrolled systemic disease.
  -  History of clinically significant heart, lung, or eye/vision problems.
  -  The subject has high blood pressure that is not well-controlled with medication.
  -  The subject has a permanent pacemaker.
  -  The subject is pregnant or breastfeeding.
  -  Positive for Hepatitis B, Hepatitis C, or HIV.

Relevance to patient case: definitely relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Trial Evaluating Combined Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma

Summary: GATE 1 is an open-label, non-comparative, multicentric study evaluating the efficacy and tolerance of the combined use of Gemcitabine, Trastuzumab and Erlotinib as a first-line chemotherapy in metastatic pancreatic cancer patients.
  The patients will be treated intravenously with Gemcitabine at a dose of 1000 mg/m2 for 30 min. For the first eight weeks, Gemcitabine will be administered once weekly for 7 weeks followed by one week of rest. Subsequently, Gemcitabine will be administered once weekly for three weeks followed by one week of rest.
  Trastuzumab will be administered once a week at a dose of 4 mg/kg over 90 min. at D1 and then at 2 mg/kg over 30 min. for the subsequent infusions.
  Erlotinib will be administered orally at a dose of 100 mg/day from C1D1.
  The patients will be subjected to research for the EGFR, HER2 and KRAS status.


Eligibility: Inclusion Criteria:
  -  Metastatic pancreatic adenocarcinoma confirmed by histology
  -  Tumor sample available
  -  Measurable lesion according to RECIST criteria
  -  Performance status ≥ 1
  -  Life expectancy > 3 months
  -  Hematology: Hb ≥ 9g/dL, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3
  -  Renal function: creatinine ≤ 1.5 x ULN
  -  Hepatic function: total bilirubin ≤ 2.5 x ULN, transaminases ≤ 5 x ULN
  -  Left ventricular ejection fraction (LVEF) ≥ 50%
  -  At least a 6-month delay between the end of any previous gemcitabine-based chemotherapy and diagnosis of metastases
  -  Social security
  -  Informed consent obtained prior to inclusion.
  Exclusion Criteria:
  -  Non metastatic advanced local disease
  -  Presence of cerebral metastases or symptomatic leptomeningeal carcinomatosis
  -  Others cancers except BBC and cervical cancer receiving curative treatment
  -  No previous treatment by Erlotinib or Trastuzumab
  -  Known severe hypersensitivity to Erlotinib, Trastuzumab, murine proteins or Gemcitabine
  -  Presence of significant co-morbidities
  -  Concomitant treatment with other experimental products or other anticancer therapies
  -  Breastfeeding or pregnant female, or patient of reproductive age not using adequate contraception
  -  Legal incapacity or limited legal incapacity

Relevance to patient case: definitely relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Pancreatic Intraepithelial Neoplasia (PanIN) and the Association With Recurrence of Pancreatic Adenocarcinoma

Summary: The research purpose of this project is to create a registry, and blood and tissue bank for individuals at high-risk for pancreatic cancer. We plan to conduct histopathological and molecular analysis of resected pancreatic tissue prospectively collected from a cohort of pancreatic cancer patients.

Detailed description: Pancreatic cancer is the fifth leading cause of cancer-related death in the United States. In order to improve outcomes of this disease, significant research efforts have focused on understanding the changes that occur in the pancreas prior to tumor occurrence. The types of changes most often associated with tumor have been named pancreatic intraepithelial neoplasia (PanIN). It is not yet clear how to identify the PanIN lesions most likely to develop into cancer and the length of time required for this progression. In order to evaluate these questions, we are interested in examining the microscopic and genetic characteristics of PanIN lesions in two "high-risk" patients: 1) patients who underwent surgery for pancreatic cancer and developed tumor recurrence after surgery and 2) patients with a strong family history of pancreatic cancer or with a genetic syndrome that puts them at risk for pancreas cancer. The surgical specimens from these patients will be evaluated by a pathologist for evidence of widespread PanIN lesions. In addition, PanIN lesions will be tested for abnormalities in several major genes that are known to be important in pancreatic cancer.

Eligibility: Inclusion Criteria:
  -  Tissue-confirmed diagnosis of pancreatic adenocarcinoma.
  -  Underwent surgical resection for adenocarcinoma at Columbia-Presbyterian Medical Center with pathologically negative surgical margins.
  -  Enrolled in our Pancreatic Cancer Registry and Tissue Bank protocol (AAAA-6154).
  -  Have at least 2 relatives (of whom one must be first-degree relative) with pancreatic cancer, or have been diagnosed with a a genetic syndrome which is associated with pancreatic cancer (among the included syndromes include BRCA1/2, FAMMM, Peutz-Jeghers, HNPCC, Hereditary Pancreatitis) —OR— Have radiological or pathological (fine needle aspirate or surgical biopsy) evidence of local tumor recurrence following surgery.
  Exclusion Criteria:
  -  Metastatic disease discovered at presentation or on recurrence (exception is the familial PDC patients)
  -  Positive surgical margins.
  -  Lack of clinical followup at one year following surgery

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer.

Summary: Patients with metastatic colorectal cancer will be treated with chemotherapy according to investigators choice. In addition to chemotherapy treatment, treatment with bevacizumab will be given concomitantly. This treatment will continue during 18 weeks. Meanwhile, the patients KRAS status will be tested. After having fulfilled these 18 weeks of induction treatment, patients who has responded (complete response/partial response versus stable disease) will be randomized to maintenance treatment. Patients with KRAS WT will be randomized to either bevacizumab alone, or to bevacizumab and erlotinib. Patient with KRAS mutation will be randomized to either bevacizumab, or metronomic capecitabine. Translational research is performed, with purpose to find predictive factors in blood and tumor tissue.


Eligibility: Inclusion Criteria:
  -  Untreated metastatic colorectal carcinoma
  -  Age 18 yrs or over
  -  Measurable disease according to Response Evaluation Criteria in solid Tumors (RECIST criteria)
  -  ECOG performance status 0 or 1
  -  Life expectancy more than 3 months
  -  Adequate haematological, renal and liver function
  -  Tumor tissue available for determination of KRAS mutational status
  -  Blood sample and paraffin embedded tumor tissue for translational research
  Exclusion Criteria:
  -  Adjuvant therapy within 6 months
  -  CNS metastases
  -  Clinically significant atherosclerotic vascular disease

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Effect Of Preoperative Chemotherapy On Short-Term Outcome After Pancreatic Resection

Summary: No comparative trial investigating the effect of preoperative chemotherapy for locally advanced pancreatic cancer on short-term postoperative outcome has been published so far. The aim of the present study is to assess the potential impact of preoperative chemotherapy on short-term postoperative outcome after pancreatic resection in a case-matched series of cancer patients.

Detailed description: Between 2003 and 2011, patients with locally advanced (stage III) pancreatic cancer who were treated with preoperative chemotherapy (PCHT) underwent surgical resection. Each patient was matched with the closest two patients with pancreatic cancer ( control group ) selected from our prospective electronic database who met the following match criteria: age (+/- 3 years), gender, ASA score, type of resection, pancreatic duct diameter (+/- 1 mm), and tumour size (+/- 5 mm).

Eligibility: Inclusion Criteria:
  -  Diagnosis of pancreatic cancer
  -  Preoperative chemotherapy
  -  Pancreatic resection
  Exclusion Criteria:
  -  Metastatic disease
  -  ASA score 4

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients

Summary: This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with EGFR mutant NSCLC which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BEZ235 and MEK162.
  Study drugs will be administered orally on a continuous schedule, MEK162 bid and BEZ235 qd, a treatment cycle is defined as 28 days.


Eligibility: Inclusion Criteria:
  -  histologically/cytologically confirmed, advanced non resectable solid tumors
  -  Measurable or non-measurable, but evaluable disease as determined by RECIST 1.0
  Exclusion Criteria:
  -  Patients with primary CNS tumor or CNS tumor involvement
  -  Diabetes mellitus - Unacceptable ocular/retinal conditions
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Study of Circulating Tumoral DNA in Ovarian Cancer

Summary: Circulating tumor DNA detection and quantification in patients with ovarian cancer.

Detailed description: Technique development:
  In a first step, the different available techniques will be evaluated for specificity and sensibility using serial dilutions of cell lines with or without TP53 mutation.
  Validation:
  The tumor DNA detection rate will be estimated from patient's blood with ovarian cancer.
  The investigators will study 25 patients to obtain at least 15 patients bearing a TP53 mutation that could be characterized in the primitive tumor or metastasis. With those 15 patients, the investigators will determine the most sensitive technique and the best cost/efficiency ratio.

Eligibility: Inclusion Criteria:
  -  Age > or = 18 years.
  -  Patient with invasive ovarian cancer stage II to IV from FIGO classification.
  -  Patient treated by surgery.
  -  Patient with tumor or metastasis available for TP53 status characterization
  -  Patient able to stand a blood collection.
  -  Signed written informed consent approved by AFSSAPS and CPP.
  Exclusion Criteria:
  -  Patient without social protection / insurance.
  -  Borderline ovarian tumor.
  -  Non carcinoma ovarian tumor
  -  Patient with invasive ovarian cancer 5 years before diagnosis
  -  Current pregnancy and lactation.
  -  All social, medical, psychological, situations making the study impossible.
  -  Person deprived of liberty.

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma

Summary: This is an open label, multicenter, single-arm phase II trial with primary eqirubicine-oxaliplatin-capecitabine chemotherapy and concurrent Pmab in patients with resectable, histologically proven gastric or esophageal cancer.


Eligibility: Inclusion Criteria:
  -  Untreated, histologically confirmed, KRAS wild type, resectable gastric or esophageal adenocarcinoma
  -  T2-4 NX M0 disease
  -  ECOG performance status 0-1
  -  adequate hematological status
  -  adequate renal function
  -  adequate hepatic function
  -  adequate metabolic function
  Exclusion Criteria:
  -  pregnant or breast feeding women
  -  previous malignancy other than gastric cancer in the last 5 years except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
  -  arterial or venous thromboembolism within 6 months before enrollment
  -  clinically significant cardiovascular disease within 1 year before enrollment
  -  history of interstitial lung disease

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: MEK162 and RAF265 in Adult Patients With Advanced Solid Tumors Harboring RAS or BRAFV600E Mutations

Summary: This is a multi- center, open-label, dose finding, Phase Ib study to be conducted in two stages: a dose escalation part to determine the maximum tolerated dose (MTD) safety and tolerability of concurrent administration of MEK162 and RAF265, followed by an expansion part to further assess the safety and preliminary anti-tumor efficacy of this oral combination within two separate patient populations: i) patients with advanced solid tumors harboring BRAFV600E mutations or ii) patients with advanced solid tumors harboring RAS mutations.


Eligibility: Inclusion Criteria:
  Patients with histologically or cytologically confirmed and non-resectable advanced solid tumors for which no further effective standard therapy exists.
  -  The patients' tumors must contain documented activating somatic BRAFV600E* , NRAS or KRAS mutations (except for pancreatic cancer)
  -  All patients enrolled MUST provide fresh or archival tumor samples at baseline to enable central confirmation of BRAF or KRAS/NRAS mutations
  -  Measurable, or non-measurable but evaluable disease as determined by RECIST
  -  Adequate bone marrow function
  -  Adequate hepatic and renal function
  -  Adequate cardiovascular function
  -  Negative serum β HCG test (female patients of childbearing potential only) within 72 hrs prior to first dose
  Exclusion Criteria:
  -  Patients with a history of primary central nervous system tumors or brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases
  -  Current evidence of retinal disease; or ophthalmopathy as assessed by ophthalmologic examination at baseline that would be considered a risk factor for CSR/RVO (e.g., optic disc cupping, visual field defects, IOP > 21 mm Hg)
  -  Impaired cardio-/vascular function or clinically significant cardiovascular diseases, including any of the following:
  -  History/evidence of acute coronary syndromes (including MI, unstable angina, CABG, coronary angioplasty, or stenting) ≤ 6 months prior to starting study drugs
  -  Thromboembolic event (DVT, CVA, PE) ≤ 6 months prior to starting study
  -  Symptomatic CHF, history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality
  -  Uncontrolled arterial hypertension, defined as BP > 140/100 mmHg (average of 3 consecutive readings)
  -  History of melena, hematemesis or hemoptysis within the last 3 months
  -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Comparing Parenteral Nutrition vs Best Supportive Nutritional Care in Patients With Pancreatic Cancer

Summary: A randomised multicentre clinical phase IIIb trial for patients suffering from pancreatic adenocarcinoma receiving defined second or higher line chemotherapy and additionally parenteral nutrition (study arm A) or best supportive nutritional care (study arm B).

Detailed description: Pancreatic cancer is an extremely aggressive malignancy characterized by extensive invasion, early metastasis, and marked cachexia. Subjects are afflicted with a variety of disconcerting symptoms, including profound cachexia and deterioration in performance status, even when their tumour burden is low. Therefore, one of the most important therapeutic targets is the improvement of quality of life. Supplementation with parenteral nutrition improves Quality of Life in subjects with advanced cancer cachexia. The European Society of Parenteral and Enteral Nutrition recommend PN only for malnourished subjects but does not reflect situation in cancer cachexia patients At present, no 2nd-line therapy (or higher) is recommended for pancreatic adenocarcinoma, but often asked for.
  Within this clinical trial, we evaluate if parenteral nutrition in combination with chemotherapy in subjects with advanced pancreatic adenocarcinoma have an impact on quality of life?

Eligibility: Inclusion Criteria:
  -  Written informed consent
  -  Histological confirmed advanced pancreatic adenocarcinoma
  -  At least one previous chemotherapy (gemcitabine-based)
  -  ≥ 18 years old
  -  Body weight ≥ 50 and ≤ 95 kg
  -  BMI ≥ 19
  -  Negative pregnancy test (females of childbearing potential)
  -  Willingness to perform double-barrier contraception during study
  -  Expected life expectancy > 3 months
  Exclusion Criteria:
  -  Major surgery < 4 weeks prior to enrollment
  -  Weight loss > 2% within the last seven days or caloric intake ≤ 500 kcal expected within the next five days
  -  PINI-Index > 10
  -  Pregnancy or breastfeeding
  -  > 4 weeks of parenteral nutrition within the last 6 months
  -  Parenteral nutrition < 4 weeks prior to enrollment
  -  Vulnerable populations (e.g. subjects incapable of giving consent personally)
  -  Subject selection conflicts with warnings, precautions and contraindications stated for any investigational product

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients

Summary: This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of the orally administered phosphatidylinositol 3'-kinase (PI3K) inhibitor BKM120 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BKM120 and MEK162.
  Study drugs will be administered once daily orally on a continuous schedule. A treatment cycle is defined as 28 days.


Eligibility: Inclusion Criteria:
  -  Histologically/ cytologically confirmed, advanced non resectable solid tumors
  -  Measurable or non-measurable, but evaluable disease as determined by RECIST
  Exclusion Criteria:
  -  Patients with primary CNS tumor or CNS tumor involvement.
  -  Diabetes mellitus
  -  Unacceptable ocular/retinal conditions

Relevance to patient case: not relevant