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

Clinical trial: FOLFIRINOX in Patients With Inoperable Pancreatic Cancer

Summary: The prognosis of patients with locally advanced unresectable pancreatic cancer is poor, and the median survival is less than 1 year. FOLFIRINOX therapy, which induces tumor downstaging sufficient to allow surgical resection, could improve the overall survival of patients with locally advanced pancreatic cancer. Based on the FOLFIRINOX regimen for advanced pancreatic cancer, a phase II study of this regimen in patients with locally advanced unresectable and borderline pancreatic cancer is planned to determine the rate of conversion to operability.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed locally advanced unresectable or borderline resectable adenocarcinoma of pancreas
  -  Patients must have measurable disease as defined by RECIST 1.1 RECIST evaluations must have occurred within 4 weeks prior to study entry
  -  No evidence of hepatic or pulmonary metastatic disease by CT or CT/PET scans
  -  Male or non-pregnant and non-lactating female age > or equal to 18 years and < or equal to 70 years of age
  -  Patient must have received no prior therapy for the treatment of locally advanced unresectable or borderline resectable pancreatic cancer
  -  Patients must have adequate blood counts at baseline and blood chemistry levels
  -  Patient has ECOG Performance Status 0 to 1
  Exclusion Criteria:
  -  Patients with islet cell neoplasms excluded
  -  Patients with known brain metastases
  -  Therapeutic Coumadin for a history of pulmonary emboli or deep vein thrombosis (DVT)
  -  Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
  -  Known infection with HIV, hepatitis B or hepatitis C
  -  Major surgery or vascular device placement within 4 weeks prior to Day 1 of treatment in study
  -  Prior chemotherapy or radiation for pancreatic cancer
  -  History of allergy or hypersensitivity to the study drugs
  -  Patient is enrolled in any other clinical protocol or investigational trial
  -  Metastatic disease on radiological staging
  -  Prior malignancy within last 3 years
  -  Significant cardiac disease
  -  Any prior gastrointestinal (GI) disease or history of prior pelvic or abdominal radiation in which in opinion of the investigator may place the patient at increased risk
  -  peripheral sensory neuropathy > or equal to grade 2 at baseline

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

Clinical trial: NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer

Summary: The purpose of this study is to evaluate the safety and feasibility of the NanoKnife Low Energy Direct Current (LEDC) System when used to treat unresectable pancreatic adenocarcinoma. Safety will be reviewed by means of analysis of adverse events, including serious adverse events, laboratory data, physician exam findings, and vital signs.


Eligibility: Inclusion Criteria:
  1. male or female
  2. >/= 18 years of age
  3. meets criteria for locally advanced unresectable pancreatic adenocarcinoma, as radiographically proven pancreatic cancer as determined by a surgical oncologist via pancreatic CT or who were initially thought to be resectable; however at the time of surgery were upstaged to unresectability, via direct visualization
  4. tumor size must be < 4 cm and must be measurable
  5. must have an INR <1.5
  6. must be unresponsive to chemotherapy as demonstrated with either CT or MR imaging and not have taken any chemotherapy agents within 14 days of treatment with the NanoKnife LEDC System
  7. are willing and able to comply with the protocol requirements
  8. are able to comprehend and willing to sign an Informed Consent Form (ICF)
  Exclusion Criteria:
  1. a baseline creatinine reported as > 2.0 mg/dL
  2. have any reported baseline lab values with a grade 3 or 4 toxicity as defined by the CTCAE Version 3.0
  3. inability to stop antiplatelet and Coumadin therapy for 7 days prior to and 7 days post treatment with the NanoKnife System
  4. known history of contrast allergy that cannot be medically managed
  5. known hypersensitivity to the metal in the electrodes (stainless steel 304L) that cannot be medically managed
  6. unable to be treated with a muscle blockade agent (e.g. pancuronium bromide, atracurium, cisatracurium, etc)
  7. women who are pregnant or currently breast feeding
  8. women of childbearing potential who are not utilizing an acceptable method of contraception
  9. have taken an investigational agent within 30 days of visit 1
  10. have implanted cardiac pacemakers or defibrillators
  11. have implanted electronic devices or implants with metal parts in the immediate vicinity of a lesion
  12. have a history of epilepsy or cardiac arrhythmia (atrial or ventricular fibrillation)
  13. have a recent history of myocardial infarction (within the past 2 months)
  14. have Q-T intervals greater than 550 ms unless treated with an Accysync Model 72 synchronization system controlling the NanoKnife system's output pulses.

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

Clinical trial: Comparison of Survival Benefit of Panitumumab With Supportive Care to Best Supportive Care Alone in Patients With Metastatic Colorectal Cancer

Summary: The purpose of this study is to evaluate the benefit of panitumumab in addition to best supportive care compared to best supportive care alone in patients with chemorefractory wild-type KRAS (Kirsten rat sarcoma viral oncogene homolog) metastatic colorectal cancer.


Eligibility: Inclusion Criteria:
  -  Diagnosis of metastatic colorectal cancer (CRC)
  -  Wild-type (without mutation in codons 12 and 13) KRAS gene in tumor tissue confirmed by a central laboratory
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  -  At least 1 measurable or non-measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.
  -  Treatment failure (defined as failure due to either disease progression [clinical or radiological] or toxicity [treatment intolerance]) of a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease. Oxaliplatin and irinotecan may have been administered sequentially or in combination.
  -  Disease relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will also be considered as treatment failure of a prior regimen for metastatic disease
  -  Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of CRC
  -  Man or woman at least 18 years of age
  -  Adequate hematologic, renal, hepatic and metabolic function
  -  Negative pregnancy test within 72 hours before randomization (for women of childbearing potential only)
  -  Subject or subject's legally acceptable representative has provided informed consent.
  -  Other protocol-specified criteria may apply
  Exclusion Criteria:
  -  Symptomatic brain metastases requiring treatment
  -  History of another primary cancer within 5 years of randomization
  -  Prior anti-epidermal growth factor receptor (EGFR) antibody therapy (eg, panitumumab or cetuximab) or treatment with small molecule EGFR inhibitors (eg, gefitinib, erlotinib, lapatinib)
  -  Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) within 21 days before randomization
  -  Radiotherapy within 14 days before randomization.
  -  Exclusion Criteria for corrected QT (QTc) Evaluation Subpart of the Study: Prolongation of QT/QTc interval > 450 milliseconds at screening
  -  Other protocol-specified criteria may apply

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

Clinical trial: Study to Evaluate if Neoadjuvant Radiotherapy Improves Recurrence Free Survival in Pancreatic Head Cancer

Summary: Net-Pac investigates if radiation prior to surgical resection improves survival in patients with pancreatic head cancer without metastases.

Detailed description: The trial is designed to show that neoadjuvant radiotherapy followed by surgery improves local recurrence free survival compared to surgery alone in patients with resectable adenocarcinoma of the pancreatic head.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed adenocarcinoma of the pancreatic head
  -  Age ≥ 18 years
  -  Signed informed consent
  -  ECOG performance status of 0-2
  Exclusion Criteria:
  -  Curative resection is not feasible or presence of metastatic disease
  -  Patients not eligible for surgery (ASA ≥ 4)
  -  Participation in an other clinical trial
  -  Unable or unwilling to sign the informed consent

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

Clinical trial: Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in KRAS Mutant Non-small Cell Lung Cancer

Summary: Study IPI-504-15 is a Phase 1b/2 clinical trial to evaluate the safety and efficacy of retaspimycin HCl (IPI-504) plus everolimus in patients with KRAS mutant Non-small Cell Lung Cancer (NSCLC).

Detailed description: This is a Phase Ib/2 study of retaspimycin HCl (IPI-504) in combination with everolimus. The Phase 1b portion is to test the safety and tolerability of retaspimycin HCl (IPI-504) in combination with everolimus and determine the highest dose of retaspimycin HCl (IPI-504) and everolimus that can safely be given in combination. The Phase 2 portion of this study will continue the evaluation of safety of retaspimycin HCl (IPI-504) in combination with everolimus and compare the effect of the study drugs on tumor response and life expectancy in patients with KRAS mutant NSCLC.

Eligibility: Inclusion Criteria:
  1. ≥18 years of age
  2. Voluntarily sign an informed consent form (ICF).
  3. Pathological diagnosis of KRAS mutation positive NSCLC - Stage IIIB or IV
  4. Archival NSCLC tissue available to provide for analysis or have a lesion that is accessible for biopsy
  5. Experienced disease progression during or after receiving at least 1 prior platinum-containing chemotherapy regimen.
  6. ECOG performance of 0-1.
  Exclusion Criteria:
  1. Prior treatment with IPI-504 or other Hsp90 inhibitors.
  2. Prior treatment with everolimus, other rapamycin analogs, AP23573(Ridaforolimus), rapamycin, or other mTOR inhibitors.
  3. Has not recovered from any toxicities related to prior treatment (to Grade 1 or baseline), excluding alopecia.
  4. Inadequate hematologic function defined as:
  5. Inadequate hepatic function defined by:
  6. Inadequate renal function defined by serum creatinine >1.5 x ULN.

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

Clinical trial: Resectability of Pancreatic Head Cancer by Contrast-enhanced MDCT:a Multi-center Study

Summary: The purpose of this multicenter and double-blind clinical trial is to prospectively assess the sensitivity, specificity, negative predictive value, positive predictive value, and accuracy in respectability of pancreatic head cancer with contrasted-enhanced MDCT and its various post processing techniques, taking operational and pathological records as the gold standard.


Eligibility: Inclusion Criteria:
  -  Patients with (or suspected) pancreatic head cancer
  -  Being examined by contrasted-enhanced MDCT
  -  Receiving surgical treatment (including palliative surgery) in all research centers
  Exclusion Criteria:
  -  Patients having (or suspected) pregnancy or breast-feeding
  -  Patients having allergic reactions to iodinated contrast agents or Hypersensitivity reactions to allergens(including drugs)
  -  Patients receiving ERCP before contrasted-enhanced MDCT examination
  -  Patients without surgery because of a high degree of surgical risk

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 the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma

Summary: This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment phase.


Eligibility: Inclusion Criteria:
  -  Initial diagnosis of metastatic pancreatic cancer must have occurred ≤6 weeks prior to the completion of screening.
  -  The presence of measurable metastatic pancreatic cancer documented by contrast enhanced CT (or MRI) scan in addition to 1 of the following:
  1. Histological diagnosis of pancreatic adenocarcinoma confirmed by pathologist OR
  2. Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreatic origin in conjunction with either:
  1. The presence of a mass in the pancreas OR
  2. A history of resected pancreatic carcinoma
  -  Measurable disease per RECIST (ver. 1.1)
  -  ECOG Performance Status of 0 or 1.
  -  Adequate hepatic, hematologic and renal functions.
  Exclusion Criteria:
  -  A history or evidence of clinically significant disorder other than metastatic cancer of the pancreas.
  -  A diagnosis of pancreatic islet neoplasms.
  -  Subject has undergone major surgery other than diagnosis surgery within 4 weeks of randomization
  -  Presence of biliary obstruction requiring external drainage
  -  Brain metastases.
  -  Unstable cardiovascular function within the last 6 months of screening
  -  Clinically active liver disease, including active viral hepatitis (HBV or HCV) or cirrhosis
  -  Known HIV infection.
  -  Uncontrolled hypertension at Screening
  -  History or presence of any form of cancer, other than pancreatic cancer, within the 3 years prior to enrollment
  -  Prior or concurrent anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) for the treatment of inoperable locally advanced or metastatic pancreatic cancer; prior radiotherapy and chemotherapy given as pre-operative neoadjuvant therapy or radio sensitizers for locally advanced pancreatic cancer are allowed.
  -  Uncontrolled systemic fungal, bacterial or viral infection
  -  Participation in an investigational drug or device trial with therapeutic intent within 30 days prior to study

Relevance to patient case: not relevant