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

Clinical trial: Feasibility of Obtaining and Characterizing Circulating Tumorigenic Cells in Patients With Pancreatic Adenocarcinoma

Summary: The purpose of this study is to collect blood samples and study cancer cells found in these blood samples from patients with pancreatic cancer. Prior research has discovered that tumor cells can be collected from the blood of patients with pancreatic and other cancers.
  The physicians have developed techniques for isolating and analyzing cancer cells using a simple blood test. They will study how these cells relate to how chemotherapy works. They hope to use this information to guide choices of treatment for patients in the future.


Eligibility: Inclusion Criteria:
  -  Histological or cytological diagnosis of pancreatic adenocarcinoma, confirmed at MSKCC.
  -  Patient eligible for chemotherapy treatment.
  -  Prior surgery, chemotherapy and/or radiation therapy for pancreatic adenocarcinoma is permitted.
  -  ECOG performance status 0-2.
  -  A minimum age of 18 years old.
  Exclusion Criteria:
  -  Known to be HIV positive on antiretroviral therapy
  -  Prior organ allograft
  -  Any medical or psychiatric condition that may interfere with the ability to comply with protocol procedures

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: Efficacy and Safety of Simtuzumab With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma

Summary: This randomized study compares the efficacy of simtuzumab (GS-6624) versus placebo in combination with FOLFIRI (fluorouracil, leucovorin, and irinotecan) chemotherapy regimen in participants with metastatic KRAS mutant colorectal cancer.


Eligibility: Inclusion Criteria:
  -  Metastatic Colorectal Carcinoma with KRAS mutation.
  -  Received first line therapy and discontinued part or all of first line therapy.
  -  Estimated life expectancy > 3 months.
  -  Stage IV disease.
  -  Eastern Cooperative Oncology Group (ECOG) 0-2.
  -  Adequate hepatic and hematologic function
  -  No major operations within 4 weeks prior to treatment start.
  Exclusion Criteria:
  -  More than 1 prior chemotherapy regimen for stage 4 colorectal cancer.
  -  Experimental medical treatment within 30 days prior to study entry.
  -  Known or suspected cerebral metastases.
  -  History or presence of any form of cancer, other that colorectal cancer, within the 3 years prior to enrollment.
  -  Known dihydropyrimidine dehydrogenase-deficiency (special screening not required).
  -  Subjects with angina pectoris, poorly controlled ventricular arrhythmias (does not include asymptomatic, occasional premature ventricular contractions), history of clinically significant coronary heart disease or cardiomyopathy, or ECG abnormalities consistent with ischemia.
  -  Uncontrolled hypertension (seated systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) at Screening.
  -  Clinically active liver disease, including active hepatitis (any etiology) or cirrhosis.
  -  Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) within 21 days prior to randomization
  -  Prior irinotecan therapy for metastatic disease is not permitted.
  -  Systemic fungal, bacterial, viral, or other infection.

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: Dose-escalation, and Safety Study of LDE225 and Gemcitabine in Locally Advanced or Metastatic Pancreatic Cancer Patients

Summary: This phase Ib study includes two phases: dose escalation phase and safety expansion phase.
  During the dose escalation phase, successive cohorts of eligible patients (minimum 3 and maximum 6 evaluable patients per cohort) will receive increasing oral doses of LDE225 administered on a continuous once daily (QD) dose in combination of gemcitabine. This phase of the study will determine the maximum tolerated dose (MTD) and/ or recommended dose for expansion (RDE) of LDE225 administered in combination with gemcitabine in locally advanced or metastatic pancreatic adenocarcinoma patients.
  During the safety expansion phase, once the MTD of LDE225 is established, additional patients will be enrolled and treated at the MTD of LDE225 in combination with gemcitabine in order to further evaluate its safety, tolerability and explore the potential efficacy of the combined treatments on the patients in locally advanced or metastatic pancreatic adenocarcinoma.


Eligibility: Inclusion Criteria:
  -  Patients with locally advanced or metastatic pancreatic adenocarcinoma that have not been previously treated or have progressed despite chemotherapy
  -  Performance status of 0 or 1 per WHO classification
  -  Adequate hematologic , renal and liver function
  -  Adequate blood creatine kinase value (CK < 1.5ULN)
  Exclusion Criteria:
  -  Treatment with prior radiotherapy
  -  Pancreatic cancer that is potentially curable by surgery
  -  Women of childbearing potential unless they are using highly effective method of contraception Other protocol-defined inclusion/exclusion criteria may apply
  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: Interest of Saline MR Peritoneography for Pre-operative Assessment of Rectal Cancer

Summary: MR saline peritoneography could be useful to demonstrate the peritoneal outline of the pouch of Douglas. The investigators think that the localization of the rectal tumor in function of this anatomic mark could be decisive for pre-operative assessment.


Eligibility: Inclusion Criteria:
  -  Rectal adenocarcinoma
  Exclusion Criteria:
  -  Metastatic disease
  -  under 18y patient
  -  woman of childbearing age

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: Xeloxiri as First-line Treatment in Patients With Advanced Unresectable Pancreatic Adenocarcinoma

Summary: This is an open-label, single centre, single-arm phase II study which aims to assess the efficacy and tolerability of triplet combination of capecitabine, oxaliplatin and irinotecan (Xeloxiri regimen) in treating patients with advanced unresectable pancreatic carcinoma. Clinical data from patients diagnosed with pancreatic adenocarcinoma will be collected and analyzed in this study. The patients' data will be collected and maintained in the Division of Medical Oncology of the University Department of Medicine, Queen Mary Hospital, Hong Kong.


Eligibility: Inclusion Criteria:
  -  Adults ≥ 18 years of age, male or female.
  -  Histopathologically or cytologically confirmed adenocarcinoma of the pancreas.
  -  ECOG performance status 0 to 2.
  -  Adequate bone marrow reserve.
  -  Absolute neutrophil count > 1x10^9/L.
  -  Total bilirubin <3 times the upper limit of the normal range.
  -  Life expectancy ≥ 12 weeks.
  -  Signed written informed consent form.
  Exclusion Criteria:
  -  Prior malignant disease other than pancreatic cancer.
  -  Patients suitable for surgical or locoregional therapies.
  -  Patients who have prior anticancer therapy for pancreatic cancer.
  -  Patients unable to swallow oral medications.
  -  Any evidence of brain metastasis (unless the patient is >6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry).
  -  Active clinically serious infections (> grade 2 NCI / CTC Adverse Event version 3.0).
  -  History of allergy to platinum compounds.
  -  Patients who have chronic inflammatory bowel disease and/or bowel obstruction.
  -  Patients who have severe bone marrow failure.
  -  Patients undergoing renal dialysis.
  -  History of HIV infection.
  -  Seizure disorder requiring medication (such as steroids or anti-epileptics).
  -  Women who are pregnant or breast-feeding, or women of child-bearing potential who are unable or unwilling to practice a highly effective means of contraception.
  -  Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results.

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: A Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors

Summary: This is a multi-center, open-label, phase Ib/II study. First, the aim of the phase Ib part is to estimate the MTD(s) and/or to identify the recommended phase II dose(s) (RP2D) for the combination of MEK162 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. The dose escalation part of the study will be guided by a Bayesian Logistic Regression Model (BLRM). At least 18 patients are expected to be enrolled in the dose escalation part.
  Following MTD/ RP2D declaration, patients will be enrolled in three phase II arms to assess efficacy of the combination as well as to better understand the safety, tolerability, PK, antibody concentrations and PD of the combination at MTD/RP2D. Phase II arm 1 will consist of approximately 25 patients with KRAS-mutant colorectal adenocarcinoma. Phase II arm 2 will consist of approximately 20 patients with metastatic pancreatic adenocarcinoma. Phase II arm 3 will consist of approximately 28 patients with mutant BRAFV600 melanoma.
  Patients will be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurs first. All patients will be followed up - at minimum patients must complete the safety follow-up assessments 30 days after the last dose of the study treatment.


Eligibility: Inclusion Criteria:
  -  Patients aged ≥ 18 years
  -  Patients with advanced solid tumors (CRC, melanoma) with documented somatic KRAS or BRAFV600 mutations in tumor tissue. Patients with metastatic pancreatic adenocarcinoma may be enrolled irrespectively of KRAS or BRAFV600 mutational status.
  -  Patients must have relapsed or progressed following standard therapy or patients for whom no standard anticancer therapy exists.
  -  Measurable disease as determined by RECIST v1.1. World Health Organization (WHO) Performance Status (PS) ≤ 2.
  -  Adequate organ function
  -  Negative serum pregnancy test
  Exclusion Criteria:
  -  Prior therapy with MEK- or IGF-1R- inhibitor
  -  History or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or retinal degenerative disease
  -  Patients with known history of severe infusion reactions to monoclonal antibodies
  -  Patients with primary CNS tumor or CNS tumor involvement
  -  History of thromboembolic event requiring full-dose anticoagulation therapy
  -  Clinically significant cardiac disease
  -  History of another malignancy within 2 years
  -  Pregnant or nursing (lactating) women
  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: Mutation Analysis and Copy Number Changes of KRAS and BRAF Gene in Taiwanese Cases of Biliary Tact Adenocarcinoma

Summary: Cholangiocarcinoma is a fatal malignant neoplasm originating from biliary tracts and constitutes about 5-10% of primary liver cancers, characterized by a poor prognosis. High prevalence in southeast and eastern Asia has been observed. At present, the cellular and molecular mechanisms leading to oncogenesis of cholangiocarcinoma remain unclear.
  The RAS gene product has a key role in controlling cell growth and differentiation through its intrinsic GTPase activity. Point mutations that activate the RAS protein and its downstream cascade have been observed in human tumors. Both KRAS and BRAF are members of the RAS-RAF-MEK-ERK-MAP kinase pathway which mediates cellular response to growth signals. Somatic KRAS mutations are found at high rates in leukemia, colon cancer, pancreatic cancer and lung cancer. Studies from European and Japanese groups have recently described that activating KRAS/ BRAF mutations may play a role in the carcinogenesis of cholangiocarcinoma of the biliary tracts, but our preliminary data demonstrated low frequency of KRAS and BRAF mutation in the same tumor as well as the results from Thailand. In this study, the investigators hypothesize copy number changes rather than genetic mutation of either KRAS or BRAF genes may be the key findings of Taiwanese cases of the adenocarcinoma from the biliary tracts.


Eligibility: Inclusion Criteria:
  -  The patients diagnosed as biliary tact adenocarcinoma.

Relevance to patient case: not relevant