araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.

Summary: Biliary atresia is a congenital disorder of bile duct development or destruction of established but immature bile ducts. The study tests the hypothesis that post-operative steroids improve outcome following the Kasai procedure - the commonest surgical treatment.

Detailed description: Biliary atresia is a potentially fatal condition of infants presenting as persisting jaundice in the first few weeks of life. The disease is characterised by obstruction and damage to the intra and extrahepatic parts of the biliary tree. Within the liver there is also a pronounced inflammatory response. The initial treatment is an attempt, by surgery, to restore bile flow by excising the obliterated extrahepatic bile ducts and joining part of the intestine to the bile "root" of the liver (the porta hepatis). This is known as the Kasai procedure. This is successful in ~50% of cases in reducing the level of jaundice to near-normal values. The use of steroids post-operatively has been suggested as improving outcome by diminishing the inflammatory response.

Eligibility: Inclusion Criteria:
  -  biliary atresia
  Exclusion Criteria:
  -  <100 days at portoenterostomy
  -  no other anomalies (e.g. Biliary Atresia Splenic Malformation syndrome)
  -  anu contra-indications to corticosteroids

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer

Summary: To assess the safety and efficacy of PF-00299804 in patients with advanced lung cancer.


Eligibility: Inclusion Criteria:
  -  Advanced NSCLC
  -  Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib or gefitinib
  -  Prior treatment with no more than two chemotherapy regimens, including adjuvant treatment
  -  Measurable disease
  Exclusion Criteria:
  -  Chemotherapy, radiotherapy, biological or investigational agents within 4 weeks of baseline disease assessment
  -  Patients who lack of tolerance of erlotinib therapy
  -  Patients with known brain Metastases
  -  Patients with demonstrated history of or presence of interstitial lung disease.

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Registry for Patients With Acquired Resistance to Small Molecule Kinase Inhibitors in Non-Small-Cell Lung Cancer

Summary: The purpose of this study is to try to learn more about how small molecule kinase inhibitors work in treating lung cancer. Some early studies have shown that gefitinib, erlotinib and similar drugs are more likely to work if a particular DNA change (also known as a mutation) is found in a protein that is important in lung cancer. This protein is called the epidermal growth factor receptor (EGFR). Since small molecule kinase inhibitors sometimes stop working, we would like to examine your tumor to learn why these medicines are not working as well. Your tumor will be examined for a variety of things including changes in the DNA of the EGFR. We will also sequence parts of the genes for HER2, HER3, HER4, and KRAS, other proteins thought to be important in lung cancer.

Detailed description: The goal of this protocol is to determine mechanisms of resistance to epidermal growth factor (EGFR) tyrosine kinase inhibitors (EGFR-TKI) in non-small cell lung cancer (NSCLC). A number of trials have shown small molecule kinase inhibitors to be active agents in the treatment of NSCLC [1]. Clinically these drugs have been noted to produce dramatic but infrequent responses. Mutations in the epidermal growth factor receptor have been shown to correlate with sensitivity to gefitinib and erlotinib[2,3]. However, we know that most patients who have initial responses to EGFR-TKI eventually progress. The mechanism of acquired clinical resistance to these inhibitors in patients incompletely understood.
  This is a protocol to study clinical characteristics and biopsy tissue of patients with non-small cell lung cancer who have had previous clinical response to small molecule kinase inhibitors and subsequently experience progression of disease. The tissues and other specimens will be used to carry out laboratory studies to explore the molecular basis of sensitivity and resistance to small molecule kinase inhibitors.

Eligibility: Inclusion Criteria:
  Patients diagnosed with unresectable or metastatic non-small cell lung cancer (NSCLC) and who fulfill the following eligibility criteria will be considered eligible for this study.
  -  Patient must have previously received treatment with small molecule kinase inhibitors targeting at least, in part, EGFR patients may have received other treatments since treatment with small molecule kinase inhibitors including radiation or chemotherapy)
  -  Development of disease progression while actively receiving tyrosine kinase inhibitor
  -  Signed informed consent
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Tumor Registry of Advanced Renal Cell Carcinoma

Summary: The purpose of this registry is to record information of therapy reality of metastatic or locally advanced Renal Cell Carcinoma by office-based medical oncologists in Germany.

Detailed description: The RCC Registry is a prospective, longitudinal, nation wide cohort study that collects data on the treatment reality of patients with mRCC. At inclusion, data in patient characteristics, comorbidities, tumor characteristics, and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. Patients are followed until death or for a maximum of 3 years.

Eligibility: Inclusion Criteria:
  -  Patients with metastatic or locally advanced Renal Cell Carcinoma requiring therapy
  -  Start of first palliative therapy within 1 year before enrollment of patient to registry; since enrollment of 1000 Patients: start of first palliative therapy within 4 weeks before enrollment
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Phase II Study of Brivanib (BMS-582664) to Treat Multiple Tumor Types

Summary: The purpose of this study is to determine if gastric/esophageal, lung, pancreatic, bladder and sarcoma patients show benefit from brivanib treatment. Patients who clearly do, stay on treatment. Those in which it is unclear will be randomized to continue or withdraw treatment to determine whether that benefit is related to brivanib


Eligibility: For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
  Inclusion Criteria:
  -  Life expectancy at least 3 months
  -  Diagnosis of a solid tumor which is unresectable in which no approved effective therapy exists or for subjects who are intolerable to such therapy. The initial enrollment will focus on non-small cell lung, gastric/esophageal adenocarcinoma, soft tissue sarcoma, transitional cell carcinoma, and pancreatic cancer including ampulla of Vater tumors
  -  Adequate tumor sample
  -  Adequate recovery (baseline or Grade 1) from recent therapy. At least 1 week must have elapsed from the time of a minor surgery, and at least 8 weeks for major surgery or radiation therapy
  Exclusion Criteria:
  -  Subjects with known brain metastasis.
  -  Subjects with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastases are ruled out by CT or MRI
  Medical History and Concurrent Diseases:
  -  History of thrombo-embolic disease within the last six months requiring therapeutic anticoagulation
  -  Subjects with history of poor wound healing or non healing ulcers
  -  Uncontrolled or significant cardiovascular disease
  Allergies and Adverse Drug Reactions:
  -  History of allergy to brivanib its drug class, or related compounds
  Prohibited Treatments and/or Therapies:
  -  Exposure to any investigational drug within 4 weeks of enrollment
  -  Other concurrent chemotherapy, hormonal therapy, immunotherapy regimens or radiotherapy, standard or investigational. Subjects may continue to receive hormone replacement therapy
  -  Prior exposure to brivanib

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Efficacy Analysis of Cetuximab Plus Irinotecan in Patients With Wild-type KRAS Without Regard to Epidermal Growth Factor Receptor (EGFR) Expressions

Summary: The purpose of this study is to investigate the response rate of cetuximab plus irinotecan every 2 weeks in patients harboring wild-type KRAS with and without detectable EGFR-expressing metastatic CRC after failure to irinotecan in an exploratory manner.

Detailed description: Twenty patients with positive-EGFR results and 20 patients with negative-EGFR results will be accrued in this study. All patients should have wild-type KRAS.

Eligibility: Inclusion Criteria:
  -  Colorectal adenocarcinoma, Wild KRAS, 18-75 yr
  -  Estimated life expectancy of more than 3 months
  -  ECOG performance status of 0 to 1 at study entry
  -  Adequate bone marrow function
  -  Adequate liver function
  -  Documented progression during or within 3 months of irinotecan-containing regimens as a first-line chemotherapy
  -  Immunohistochemical evidence of a presence or absence of EGFR expression by PharmDx Kit
  -  Informed Consent
  Exclusion Criteria:
  -  Central nervous system (CNS) metastases or prior radiation for CNS metastases.
  -  Intestinal obstruction or impending intestinal obstruction due to peritoneal carcinomatosis
  -  Surgery (excluding biopsy for diagnosis) during 4 weeks prior to inclusion in the study.
  -  Evidence of gastrointestinal bleeding
  -  Exposure to Cetuximab
  -  Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment
  -  KRAS mutant Status
  -  Patients with serious toxicity to previous irinotecan-based chemotherapy
  -  Other serious illness or medical conditions

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers

Summary: To assess the feasibility of administering induction chemotherapy with gemcitabine and docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation gemcitabine/docetaxel chemotherapy.


Eligibility: Inclusion Criteria:
  -  Patients must have biopsy-proven, resected with curative intent cholangiocarcinoma, gallbladder, pancreatic or ampullary adenocarcinoma.
  -  Patients must be 18 years or older.
  -  Patients must have a NCI CTC Performance Status of 0-2.
  -  Patients must not have any prior chemotherapy or radiation therapy for this current malignancy.
  -  At least 3 weeks should have elapsed since any surgery requiring general anesthesia.
  -  Patients must have no prior malignancies except for basal or squamous skin cancers, cervical carcinoma-in-situ, unless in remission for >5years
  -  Pregnant patients are not eligible. Non-pregnant status will be determined in all women of childbearing potential. All patients will be required to use an effective means of contraception if sexually active during therapy.
  -  Initial Required Laboratory Values:
  -  Absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 150, 000/mm3, and hemoglobin ≥ 9 g/dL.
  -  Serum creatinine should be ≤ 2 mg/dL.
  -  Serum bilirubin should be ≤ 3.0 mg/dL (biliary stents allowed).
  -  Serum transaminases should be ≤ 5-fold the institutional upper limits.
  -  Patients must not have any co-existing severe medical illnesses, such as unstable angina, uncontrolled diabetes mellitus, uncontrolled arrhythmia or uncontrolled infection.
  -  Patients must be able to sign an informed consent.
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)

Summary: The primary objective of this study is to compare the safety of 100 mg carboplatin administered intraductally once on Day 1 or twice on Days 1 and 15 in women with ductal carcinoma in situ (DCIS) undergoing surgical management 2 to 4 weeks following the Day 15 intraductal infusion. Secondary objectives are to characterize the biologic and clinical effects with respect to: pharmacokinetics, extent of disease on MRI and mammogram, histopathological assessment of DCIS, and biomarker measurement of Ki-67, TUNEL and G-actin.

Detailed description: This is a randomized, 3-arm, saline-controlled study involving women undergoing surgical management of DCIS. Forty-five (45) women who have been diagnosed with DCIS by core biopsy will receive intraductal administration of either carboplatin or normal saline (NS) into the DCIS-involved breast duct. Thirty (30) patients (i.e., 15 patients per arm) will receive two intraductal infusions of either 100 mg of carboplatin or NS on Days 1 and 15. Fifteen (15) patients will receive an intraductal infusion of 100 mg carboplatin on Day 1 and an intraductal infusion of NS on Day 15. Patients will undergo surgical resection 2 to 4 weeks following the Day 15 intraductal infusion (i.e. 4 to 6 weeks from diagnosis).
  The effect of carboplatin on DCIS in the pre-treatment core biopsy specimen and the resection specimen will be assessed. Venous blood samples will be collected for carboplatin PK analysis pre-dose and at 30 minutes, 1, 2, 4, and 8 hours following intraductal infusions on Days 1 and 15.

Eligibility: Inclusion Criteria:
  -  Female
  -  18 years of age or older
  -  Scheduled to undergo surgical resection in 2 weeks or longer
  -  Pathological diagnosis of DCIS requiring surgical resection
  -  DCIS diagnosed with core biopsy
  -  Mammogram within 6 weeks of diagnosis
  -  Adequate organ function as defined by the following criteria:
  Absolute neutrophil count (ANC) ≥ 1500/μl, Platelets ≥ 140,000/μl,Hemoglobin ≥ 12.0 g/dl, Creatinine < 2.0 mg/dl
  - Able to sign informed consent
  Exclusion Criteria:
  -  Current diagnosis of invasive or inflammatory breast carcinoma
  -  DCIS with microinvasion on histology on core needle biopsy
  -  Palpable mass
  -  Mass on mammography
  -  Concurrent anti-cancer therapy
  -  Prior exposure to carboplatin (related to current or past diagnosis)
  -  Prior radiation to the breast or chest wall
  -  Prior areolar or breast surgery which interrupts communication of the ductal systems with the nipple
  -  Presence of breast implants
  -  Presence of ulcerating or fungal skin lesions or infection of the breasts
  -  Pregnant or lactating
  -  Impaired cardiac function or history of cardiac problems
  -  Poor nutritional state (as determined by clinician)
  -  Presence of serious infection
  -  Scheduled for intraoperative radiation of breast or chest wall
  -  Allergies to lidocaine or marcaine
  -  Allergies to imaging dyes

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Non-Interventional Study (NIS) In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®

Summary: Primary objective: to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of SUTENT®. Secondary objectives: treatment response, hypothyroidism prevalence.The efficacy will be assessed using the Objective Response Rate, Time to Progression based on the RECIST criteria and the ECOG performance data.

Detailed description: 180 patients will be enrolled at 20 key oncological centres, the sample size is sufficient for exploratory analysis.

Eligibility: Inclusion Criteria:
  -  Patients with advanced or metastatic renal cell carcinoma.
  Exclusion Criteria:
  -  No previous cytokines therapy.

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer

Summary: The primary objective of the trial is to determine the efficacy of VANDETANIB monotherapy or VANDETANIB plus GEMCITABINE or PLACEBO plus GEMCITABINE in prolonging the progression-free survival (PFS) at the trial closure in patients with advanced (unresectable or metastatic) biliary tract cancer.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically-confirmed advanced (unresectable or metastatic) biliary tract cancer (gallbladder cancer, cancer of the extrahepatic bile duct, intrahepatic cholangiocarcinoma and ampullary carcinoma)
  -  Patients must have measurable or evaluable but non-measurable disease
  -  Chemotherapy-naïve (prior chemotherapy in the adjuvant setting completed more than 3 months before the trial entry is accepted).
  -  WHO performance status 0 to 2: patients must have a WHO PS ≤ 2
  Exclusion Criteria:
  -  Patients must not have received prior systemic therapy for advanced (unresectable or metastatic) disease; prior chemotherapy in the adjuvant setting within 3 months before the trial entry is accepted
  -  Inadequate end-organ function or Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance wit
  -  Significant cardiovascular event (e.g. myocardial infarction, superior vena cava [SVC] syndrome, New York Heart Association [NYHA] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of
  -  History of arrhythmia or QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen

Summary: This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one of these drugs, and followed for efficacy and tolerance of each.


Eligibility: Inclusion Criteria:
  -  advanced measurable Non-Small Cell Lung Cancer (NSCLC);
  -  progressed after 1-2 prior chemotherapy;
  -  Eastern Cooperative Oncology Group (ECOG) 0-2;
  -  tissue available for future KRAS/ EGFR testing
  Exclusion Criteria:
  -  prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;
  -  active or untreated Central Nervous System (CNS) metastases;

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Irinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations

Summary: The purpose of this study is to investigate the effect and the side effect profile of irinotecan and panitumumab administered every 3 weeks as 3rd line treatment for patients with metastatic colorectal cancer without KRAS mutations.

Detailed description: Colorectal cancer is one of the most frequent types of cancer in Denmark with approximately 3,400 diagnosed patients per year. The prognosis for these patients is still very poor and more than half of them will develop metastatic disease and thus be candidates for chemotherapy.
  In Denmark 5-FU and Oxaliplatin or Irinotecan has been used for several years either as combination or mono therapy. In recent years biological antibodies targeted against EGFR have been added to this treatment. A newly developed antibody is Panitumumab, which enables treatment every 3 weeks instead of weekly administration.
  The effect of EGFR activation is mediated through intracellular pathways involving the KRAS protein. It has been proven that a mutation of KRAS causes the KRAS protein to be constantly activated, and patients with these mutations do not benefit from antibodies against EGFR. Approximately 40% of the patients present these mutations.

Eligibility: Inclusion Criteria:
  -  Histologically verified adenocarcinoma in colon or rectum with metastatic spread.
  -  No mutations in the KRAS gene.
  -  Resistance to 5-FU, oxaliplatin and irinotecan.
  -  Age ≥18 years.
  -  PS 0-2.
  -  Measurable disease according to RECIST criteria.
  -  Haematology: Neutrophilocytes ≥1.5 x 109/l, leukocytes ≥3.0 x 109/l, thrombocytes ≥100 and bilirubinaemia ≤3 x upper normal value. Samples no more than 4 weeks old.
  -  Fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.
  -  Acceptance that blod and tissue samples are kept for subsequent investigation of biomarkers.
  -  Oral and written informed consent.
  Exclusion Criteria:
  -  Other malignant disease within the past 5 years, excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri.
  -  Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks.
  -  Verified or clinically suspected CNS metastasis.
  -  Other experimental treatment.
  -  Serious medical disease according to investigator's judgement.
  -  Pregnant or breastfeeding women.
  -  Hypersensitivity to the active substance or to one or more of the auxiliary substances.
  -  Patients with interstitial pneumonitis or pulmonary fibrosis.

Relevance to patient case: not relevant