araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma

Summary: To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody (PDR001), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in unresectable or metastatic BRAF V600 mutant melanoma


Eligibility: Inclusion criteria Part 1: Safety run-in
  -  Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
  -  Aspartate transaminase (AST) < 2.5× ULN and Alanine transaminase (ALT) < 2.5× ULN
  -  ECOG performance status ≤ 1
  Part 2: Biomarker cohort
  -  Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
  -  At least two cutaneous or subcutaneous or nodal lesions for tumor sample collection
  -  ECOG performance status ≤ 2
  Part 3: Double-blind, randomized, placebo-controlled part
  -  Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
  -  ECOG performance status ≤ 2
  Exclusion Criteria:
  Part 1: Safety run-in
  -  Subjects with uveal or mucosal melanoma
  -  Any history of CNS metastases
  -  Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
  -  Prior loco-regional treatment for unresectable or metastatic melanoma in the last 6 month
  -  Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months
  -  Radiation therapy within 4 weeks prior to start of study treatment
  -  Active, known, suspected or a documented history of autoimmune disease
  Parts 2 & 3: Biomarker cohort & double-blind, randomized, placebo-controlled part
  -  Subjects with uveal or mucosal melanoma
  -  Clinically active cerebral melanoma metastasis
  -  Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
  -  Prior loco-regional treatment for unresectable or metastatic melanoma in the last 6 month
  -  Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months
  -  Radiation therapy within 4 weeks prior to start of study treatment
  -  Active, known, suspected or a documented history of autoimmune disease
  Other protocol-defined Inclusion/Exclusion may apply.

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Study of LXH254 and LTT462 in NSCLC

Summary: To characterize safety and tolerability of LXH254 and LTT462 combination and identify a recommended dose and regimen.


Eligibility: Inclusion Criteria:
  -  Patients must have advanced or metastatic NSCLC
  -  Presence of KRAS or BRAF mutation in tumor tissue
  -  All patients participating in this clinical trial must have progressed following standard therapy or, in the opinion of the Investigator, no effective standard therapy exists, is tolerated, appropriate or is considered equivalent to study treatment.
  -  ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
  Exclusion Criteria:
  -  Dose expansion - Group 1: Prior treatment with a RAFi (including any BRAFi and pan-RAFi), MEKi and/or ERKi. Group 2: Prior treatment with an ERKi and/or a pan-RAFi.
  -  History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
  -  Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
  -  Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
  -  Patients with Gilbert's syndrome or other heritable diseases of bile processing.
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer

Summary: The purpose of this study is to determine wether D3 lymph node dissection gives superior oncological outcomes compared to standard D2 lymph node dissection in colon cancer

Detailed description: The design involves random allocation of eligible patients to D3 or D2 lymph node dissection group in 1:1 ratio. The extent of colonic resection itself is not influenced by the randomization and is predefined by the investigator prior to randomization.
  Requirements applied to centers participating in the trial and surgeons performing procedures are described in the protocol and refer to center volume and surgeon's experience with evaluation of non-editted video-recordings of procedures.
  Routine quality control includes requirement to photograph vessels with the clip to determine the extent of lymph node dissection performed and a thorough morphological assessment of the specimen.
  After surgery patients are treated according to local standards with no difference wether D2 or D3 lymph node dissection was performed. Short-term and long-term outcomes are registered as per protocol.
  This is a superiority trial evaluating statistical superiority. With the 50% five year survival according to national registry for colon cancer, expecting 10% improvement in survival with D3 lymph node dissection, enrollment of 768 patients during 3 year accrual period followed by 5 year follow up is required for a power of 80%.
  The intent-to-treat principle is used for the data analysis.

Eligibility: Inclusion Criteria:
  -  histologically confirmed adenocarcinoma of the colon (caecum, ascending, transverse, descending, sigmoid)
  -  clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable)
  -  indications for surgical colonic resection
  -  ECOG status 0-2
  -  At least 18 years of age
  -  Written informed consent
  Exclusion Criteria:
  -  Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol
  -  Pregnancy or breast feeding
  -  Medical contraindications for surgical treatment
  -  Synchronous malignancy
  -  Non-resectable distant metastases
  -  Colon obstruction, perforation or bleeding complicating the tumor
  -  Indications for isolated transverse colon resection
  -  Neoadjuvant chemotherapy

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas

Summary: Radiotherapy plus Single-Agent Chemotherapy/Radiosensitization. Involved-field irradiation using 4-15 MV photons; plus Gemcitabine, NSC-613327.

Detailed description: This is a Phase I trial of gemcitabine given weekly as a 30 minute infusion administered concurrently with radiation in patients with locally advanced or locally recurrent pancreatic carcinoma. Patients will be treated with external beam radiation therapy in a standard manner. Gemcitabine will be administered as a 30 minute infusion beginning on the first day of irradiation and weekly afterwards for a total of 5 doses. Patients will be assessed clinically for acute toxicity which will be graded per RTOG and DCT toxicity grading system.

Eligibility: DISEASE CHARACTERISTICS:
  Histologically or cytologically proven unresectable adenocarcinoma of the pancreas or ampulla of Vater. Surgical consult at NCI confirming unresectability fulfills requirement.
  Unresectable disease defined as tumor with: Gross involvement of regional nodes or direct extension to any of the following sites: Duodenum, Spleen, Bile duct , Colon, Peripancreatic tissue, Adjacent large vessels, Stomach.
  Metastatic disease requiring local radiotherapy allowed. No CNS metastasis.
  No lymphomas or neuroendocrine tumors.
  No peritoneal carcinomatosis.
  PRIOR/CONCURRENT THERAPY:
  Biologic Therapy: More than 4 weeks since immunotherapy.
  Chemotherapy:
  No prior chemotherapy for newly diagnosed disease.
  More than 4 weeks since chemotherapy for recurrent disease (6 weeks since nitrosoureas, mitomycin, or suramin).
  Endocrine Therapy: More than 4 weeks since hormonal therapy.
  Radiotherapy:
  No prior radiotherapy for newly diagnosed disease.
  No prior abdominal or pelvic radiotherapy.
  More than 4 weeks since radiotherapy for recurrent disease. No prior radiotherapy for locally advanced disease after resection allowed.
  Surgery:
  Prior resection allowed.
  Biliary decompression or gastric bypass allowed.
  PATIENT CHARACTERISTICS:
  Age: 18 and over.
  Performance status: ECOG 0-2.
  Hematopoietic:
  ANC greater than 2,000/mm(3).
  Platelets greater than 100,000/mm(3).
  Hepatic: AST/ALT no greater than 2.5 times normal.
  Renal:
  Creatinine less than 1.5 mg/dL.
  Creatinine clearance at least 60 mL/min,
  Cardiovascular:
  No myocardial infarction within 6 months.
  No unstable angina.
  No congestive heart failure (NYHA class III/IV).
  OTHER:
  HIV seronegative.
  No medical or psychiatric contraindication to protocol therapy.
  No concurrent malignancy other than: Skin cancer, Cervical carcinoma in situ.
  No pregnant or nursing women.
  Adequate contraception required of fertile patients.

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Positional Cloning of the Gene(s) Responsible for Alagille Syndrome

Summary: The goal of the project is to identify and clone the gene(s) responsible for the Alagille Syndrome (AGS) by a positional cloning approach. The first step towards this goal is to define the smallest genomic candidate region for AGS at 20p12 and to begin to identify genes within this region which are, by definition, candidate genes for the disease. In a collaborative effort with clinician-investigators studying the Alagille syndrome, metaphase chromosomes and genomic DNA from affected individuals will be studied for subchromosomal deletions and for mutations in the candidate genes. Characterization of genes involved in Alagille syndrome could provide important insight into the pathophysiology of the disease, the development of normal liver and treatment of this disease. Recently, we and others found that mutations in Jagged1, a Notch1 receptor are responsible for Alagille Syndrome.

Detailed description: The goal of the project is to identify and clone the gene(s) responsible for the Alagille Syndrome (AGS) by a positional cloning approach. The first step towards this goal is to define the smallest genomic candidate region for AGS at 20p12 and to begin to identify genes within this region which are, by definition, candidate genes for the disease. In a collaborative effort with clinician-investigators studying the Alagille syndrome, metaphase chromosomes and genomic DNA from affected individuals will be studied for subchromosomal deletions and for mutations in the candidate genes. Characterization of genes involved in Alagille syndrome could provide important insight into the pathophysiology of the disease, the development of normal liver and treatment of this disease.

Eligibility: All enrolled affected subjects, whose samples will be analyzed in this study, must meet the criteria for the clinical diagnosis of Alagille Syndrome (Syndromic Bile Duct Paucity) which include liver biopsy findings consistent with Alagille Syndrome and at least 3 of the 5 primary clinical criteria: cholestasis, characteristic face, posterior embryotoxon, "butterfly" vertebrae and cardiac findings.

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Computer Planned Radiation Therapy in Treating Patients With Prostate Cancer

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Computer systems that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment may result in more effective radiation therapy.
  PURPOSE: This phase II trial is studying how well radiation therapy that has been planned with a computer works in treating patients with prostate cancer.

Detailed description: OBJECTIVES:
  -  Establish the efficacy of high-dose three-dimensional conformal radiotherapy in patients with intermediate prognostic risk adenocarcinoma of the prostate.
  -  Determine the PSA relapse-free survival rate of this patient population.
  OUTLINE: Patients receive high-dose three-dimensional conformal radiotherapy 4-5 days per week for at least 9 weeks.
  Patients are evaluated at least weekly during radiotherapy and at 2 and 4 months after treatment completion. Thereafter, patients are followed every 6 months for a total of 3 years.
  PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven intermediate prognostic risk (T1-T2) adenocarcinoma of the prostate
  -  Previously untreated (except for hormonal therapy)
  -  PSA levels greater than 10 ng/mL and Gleason scores no greater than 6 OR
  -  PSA levels no greater than 10 ng/mL and Gleason scores at least 7
  -  Patients requiring volume reduction of prostate prior to radiotherapy continue to be treated at least 3 months on neoadjuvant hormonal therapy prior to radiation
  -  No evidence of distant metastases
  -  No regional lymph node involvement
  PATIENT CHARACTERISTICS:
  Age:
  -  Not specified
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  No major medical illness
  -  No psychosis
  -  No metallic pelvic prosthesis
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  No prior chemotherapy
  Endocrine therapy:
  -  See Disease Characteristics
  -  Prior neoadjuvant antiandrogen therapy allowed
  Radiotherapy:
  -  No prior radiotherapy
  -  No prior pelvic irradiation
  Surgery:
  -  No prior radical surgery for carcinoma of the prostate

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Liposomal Doxorubicin in Treating Patients With Liver or Bile Duct Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients with liver or bile duct cancer.

Detailed description: OBJECTIVES: I. Determine the response rate and toxicity of doxorubicin HCl liposome in patients with carcinomas of the liver and bile ducts.
  OUTLINE: Patients receive doxorubicin HCl liposome IV over 15 minutes every 21 days. Filgrastim (G-CSF) is administered subcutaneously starting on day 2 and continuing for 10-14 days. Disease is restaged after every 3 courses. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for the first year, and then every 6 months thereafter.
  PROJECTED ACCRUAL: There will be 17-26 evaluable patients accrued into this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed carcinoma of the liver or bile ducts including hepatocellular carcinoma, cholangiocarcinoma, and gallbladder cancer Measurable or evaluable disease by CT scan (ascites, pleural effusions, and bone metastases are not considered evaluable)
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 3 mg/dL No severe cirrhosis Renal: Creatinine no greater than 3.0 mg/dL Cardiovascular: Left ventricular cardiac ejection fraction at least 45% Other: No allergy to egg or egg products Not pregnant or nursing Effective contraception required of all fertile patients
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior doxorubicin At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: Not specified

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Dolastatin 10 in Treating Patients With Metastatic Or Recurrent Liver, Bile Duct, or Gallbladder Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients with metastatic or recurrent liver, bile duct, or gallbladder cancer.

Detailed description: OBJECTIVES: I. Determine the objective response rate, time to progression, and survival of patients with previously untreated advanced hepatobiliary cancer treated with dolastatin 10. II. Determine the toxicity of this regimen in this patient population.
  OUTLINE: This is an open label, multicenter study. Patients receive dolastatin 10 IV bolus every 3 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. Patients are followed until death.
  PROJECTED ACCRUAL: A total of 14-35 evaluable patients will be accrued for this study within 9 months.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed metastatic, locally advanced, or recurrent cancer of the liver (hepatoma), bile duct, or gallbladder (cholangiocarcinoma) Bidimensionally measurable disease The following are not considered measurable lesions: Lesions seen on colonoscopic examination or barium studies Bone metastases CNS lesions CEA, CA19-9, or AFP levels Ascites No CNS disease only No symptomatic brain metastases
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALGB 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 OR Platelet count at least 75,000/mm3 in patients with clinically documented sequestration or hemodilution unrelated to primary bone marrow insufficiency Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant underlying medical or psychiatric illness No active infections No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer and carcinoma in situ of the cervix
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for advanced or metastatic hepatobiliary cancer No other concurrent chemotherapy No concurrent investigational antineoplastic drugs Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to only site of measurable disease At least 6 weeks since prior radiotherapy and recovered No concurrent radiotherapy to any lesion Surgery: Not specified

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Photodynamic Therapy in Treating Patients With Cancer of the Bile Duct, Gallbladder, or Pancreas

Summary: RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be effective treatment for cancer of the bile duct, gallbladder, or pancreas.
  PURPOSE: Phase II trial to determine the effectiveness of photodynamic therapy in treating patients who have cancer of the bile duct, gallbladder, or pancreas.

Detailed description: OBJECTIVES: I. Determine the safety and efficacy of photodynamic therapy using porfimer sodium in patients with unresectable malignant bile duct obstruction.
  OUTLINE: Patients are stratified according to tumor location (proximal vs distal). Patients receive porfimer sodium IV over 3-5 minutes on day 1, followed by percutaneous or endoscopic laser light treatment on day 3. Patients achieving partial response or complete response accompanied by an increase in total bilirubin or cholangitis may repeat treatment for a maximum of 3 courses. Patients are followed weekly for 1 month, and then monthly for 1 year.
  PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven malignant bile duct obstruction with obstructive jaundice Primary carcinoma of bile duct, gallbladder, or pancreas OR Metastatic bile duct disease Successful insertion of a percutaneous drain or endoscopic stent Unresectable disease OR Resectable disease but refusal of surgery Prior biliary plastic or metallic stent allowed, if requiring stent replacement due to recurrent jaundice or routine plastic stent change No erosion of biliary tumors into major blood vessels No evidence of bile duct perforation
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin at least 2 mg/dL Renal: Not specified Other: No history of allergies or hypersensitivity to porphyrins No porphyria No cholangitis or pancreatitis
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy or brachytherapy to the abdomen Surgery: See Disease Characteristics Other: No other prior or concurrent experimental or investigational drugs

Relevance to patient case: not relevant