araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Phase I / II Study of Irinotecan (CPT-11) Combined With l-Leucovorin (l-LV) and 5-FU in Patients With Advanced Colorectal Cancer

Summary: We performed a phase I/II study of CPT-11/5FU/l-LV in advanced colorectal cancer, to determine the optimal dose of CPT-11 and to estimate the safety and efficacy of this regimen

Detailed description: A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on patients with histological stage IV colorectal cancer given irinotecan, leucovorin plus fluorouracil. The usefulness of this regimens as 1st line therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), median survival time (MST), incidence and severity of adverse event.

Eligibility: Inclusion Criteria:
  1. Histological diagnosis of colorectral adenocarcinoma.
  2. Measurable or assessable lesions.
  3. Age: 18 ~ 75 years.
  4. Performance Status (ECOG): 0 ~ 2.
  5. No prior chemotherapy. Adjuvant chemotherapy is not defined as previous therapy.
  6. No history of radiotherapy to the abdomen.
  7. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine <1.5 mg/dl Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).
  8. Predicted survival for >3 months.
  9. Able to give written informed consent.
  Exclusion Criteria:
  1. Severe pleural effusion or ascites.
  2. Metastasis to the central nervous system (CNS).
  3. Active gastrointestinal bleeding.
  4. Active infection.
  5. Diarrhea (watery stools).
  6. Uncontrolled ischemic heart disease.
  7. Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
  8. Active multiple cancer.
  9. Severe mental disorder.
  10. Pregnancy, possible pregnancy, or breast-feeding.
  11. Flucytosine treatment
  12. Gilbert’s syndrome.
  13. Judged to be ineligible for this protocol by the attending physician.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Phase II Study of Oral S-1 Plus Irinotecan (IRIS) in Patients With Advanced Colorectal Cancer

Summary: To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and survival period. by performing a phase II study of this combination in patients with inoperable or with postoperative colorectal cancer.

Detailed description: A multicenter Open-label, single-arm, phase II clinical trial is conducted on patients with histological stage IV colorectal cancer given irinotecan plus S-1. The usefulness of this regimens as 1st line therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.

Eligibility: Inclusion Criteria:
  1. Histological diagnosis of colorectal adenocarcinoma.
  2. Measurable or assessable lesions.
  3. Age: 18 ~ 75 years.
  4. Performance Status (ECOG): 0 ~ 2.
  5. No prior chemotherapy or only one regimen of previous chemotherapy (with a washout period >4 weeks after the final day of the previous therapy). Adjuvant chemotherapy is not defined as previous therapy.
  6. No history of treatment with CPT-11 or S-1.
  7. No history of radiotherapy to the abdomen.
  8. Oral intake of S-1 is possible.
  9. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine <1.5 mg/dl (but if it is 1.0 ~ 1.5 mg/dl, the dose of S-1 can be decreased according to the dose reduction criteria to allow registration in the trial). Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).
  10. Predicted survival for >3 months.
  11. Able to give written informed consent
  Exclusion Criteria:
  1. Severe pleural effusion or ascites.
  2. Metastasis to the central nervous system (CNS).
  3. Active gastrointestinal bleeding.
  4. Active infection.
  5. Diarrhea (watery stools).
  6. Uncontrolled ischemic heart disease.
  7. Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
  8. Active multiple cancer.
  9. Severe mental disorder.
  10. Pregnancy, possible pregnancy, or breast-feeding.
  11. Flucytosine treatment
  12. Gilbert's syndrome (4).
  13. Judged to be ineligible for this protocol by the attending physician.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: A Phase II Study of Oxaliplatin Capecitabine and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer

Summary: To assess the efficacy and safety of pre-operative capecitabine and oxaliplatin followed by capecitabine with concurrent radiotherapy followed by post-operative capecitabine in the treatment of patients with locally advanced or inoperable rectal cancer.


Eligibility: Inclusion Criteria:
  -  Age over 18.
  -  Histological diagnosis of adenocarcinoma of rectum.
  -  Locally advanced/ poor prognosis primary rectal cancer defined by MRI criteria of any of the categories below;
  -  Tumour within 2 mm of mesorectal fascia ie circumferential resection margin threatened
  -  Any T3 tumour at/below levatores
  -  T3c tumour at any other level ie tumour extends >5 mm into peri-rectal fat
  -  T4 tumour
  -  Any T stage with 4 or more involved lymph nodes
  -  WHO performance status 0, 1 or 2.
  -  No evidence of metastatic disease as determined by CT scan of chest, abdomen, pelvis or other investigations such as PET scan or biopsy if required.
  -  Adequate bone marrow function with platelets > 100 X 109/l; WBC > 3 X 109/l; neutrophils > 1.5 X 109/l
  -  Normal renal function, with serum creatinine within the normal range or calculated creatinine clearance >50 ml/min.
  -  Adequate hepatic function with serum total bilirubin < 1.5 X upper limit of normal range.
  -  No concurrent uncontrolled medical conditions
  -  No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix
  -  Adequate contraceptive precautions if relevant
  -  Informed written consent
  Exclusion Criteria:
  -  Medical or psychiatric conditions that compromise the patient's ability to give informed consent
  -  Presence of metastatic disease or recurrent rectal tumour
  -  Renal impairment (creatinine clearance<30 ml/min)
  -  Pregnancy or breast feeding
  -  Patients with a lack of physical integrity of the upper gastrointestinal tract, or known malabsorption syndromes
  -  Participation in any investigational drug study within the previous 4 weeks.
  -  Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia even if controlled with medication) or myocardial infarction within the last 12 months)
  -  Patients with any symptoms or history of peripheral neuropathy.
  -  Prior pelvic radiotherapy

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Molecular Markers of Prognosis in Colorectal Cancer Patients

Summary: To correlate the molecular profile of a series of defined CRCs with prognosis and toxicity.


Eligibility: Inclusion Criteria:
  -  All patients participating in the RMHNHST study of infusional versus bolus 5FU (Saini et al. 2003).

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Clinical and Molecular Characterization of Familial Microsatellite Stable Colorectal Cancer

Summary: Two major genetic pathways leading to colorectal carcinoma can well be distinguished; the 'suppressor pathway', which is characterized by inactivation of tumor-suppressor genes and the 'mutator pathway', which is characterized by microsatellite instability. The purpose of this study is to explore a third putative pathway; microsatellite and chromosome stable colorectal cancer where an alternative cancer-causative mechanism might play a role.

Detailed description: Patients with familial colorectal cancer will be characterized with respect to family history, medical history and demographic characteristics. The histopathology of the tumors will be reviewed. Tumor specimens will be analysed on molecular defects.

Eligibility: Inclusion Criteria:
  - Colorectal cancer before the age of 51 years
  Microsatellite stable tumor
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: CHROENDOHNPCC: Early Detection of Pre-cancer Lesions in Adults With Hereditary Nonpolyposis Colorectal Cancer Syndrome

Summary: The aim of the study is to test the hypothesis that a chromoscopy colonoscopy is able to increase by 50 % the number of pre-cancer lesions or early cancer detected in patients with HNPCC syndrome, compared to a routine colonoscopy without chromoscopy.

Detailed description: Patient with HNPCC syndrome confirmed by a mutation (MLH1, MSH2, MHS1) are involved in the study. Patient have 2 colonoscopy back to back. The second coloscopy is associated to chromoscopy with carmin indigo. Endoscopist are randomised for the colonoscopy with chromoscopy and are un-awarded of the result of the first colonoscopy. Histopathology of the polyp are noted. The follow up were 1 month.

Eligibility: Inclusion Criteria:
  -  Patients with MLH1, MSH2 or MSH6 mutation.
  -  Patients concerned by early detection colonoscopy.
  Exclusion Criteria:
  -  Coloscopy of tracking since less 1an
  -  occlusive Syndrome contra-indicating the preparation for a total coloscopies
  -  Colectomies
  -  medical Conditions or serious illnesses contra-indicating a coloscopy of screening
  -  pregnant Woman or nursing
  -  Anomaly of coagulation contra-indicating the realization of biopsies and/or the exeresis of the lesion colorectal

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Irinotecan, 5-Fluorouracil and Leucovorin With or Without Iressa in the Treatment of Metastatic Colorectal Cancer

Summary: The aim of the study is to determine if Iressa added to chemotherapy with Irinotecan, 5Fluorouracil and Leucovorin can prolong the period of time without any disease worsening (Time to Progression) in patients with metastatic colorectal cancer.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed metastatic colorectal cancer
  -  Presence of measurable metastases
  -  No previous treatment for metastatic cancer
  Exclusion Criteria:
  -  No presence of Central Nervous System metastases
  -  No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  -  Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Cap/Iri Plus Cetuximab Compared to Cap/ox Plus Cetuximab in Patients With Metastatic Colorectal Cancer.

Summary: A randomized phase II-study to evaluate the safety and efficacy of capecitabine plus irinotecan plus cetuximab compared to capecitabine plus oxaliplatin plus cetuximab in first-line treatment of patients with metastatic colorectal cancer.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed metastatic colorectal cancer.
  -  EGF-receptor testing.
  -  No prior chemotherapy for colorectal cancer (except adjuvant chemotherapy with an interval ³ 6 months).
  -  No prior therapy with topoisomerase-1 inhibitors, no prior therapy directed against the EGF-pathway.
  -  No prior surgery (except diagnostic biopsy) or radiation therapy 4 weeks before start of study treatment.
  -  Measurable disease (diameter ³ 20mm, diameter ³ 10mm with spiral-CT).
  -  Male and female patients ³ 18 years, £ 75 years. Karnofsky PS ³ 70%. Life expectancy ³ 3 months. Effective contraception if risk of conception exists.
  -  Adequate bone marrow, liver and renal function (leucocytes ³3.000/µl, neutrophils ³1.500/µl, platelets ³100.000/µl, hemoglobin ³9g/dl, bilirubin £1,5x ULN, ASAT and ALAT £3x ULN (£5x ULN with liver metastasis), serum creatinine £1,5x ULN).
  -  Written informed consent.
  Exclusion Criteria:
  -  Concurrent treatment of colorectal cancer (except study medication).
  -  EGF-receptor testing not possible.
  -  Known DPD-deficiency (no particular screening necessary). Known Gilbert-Meulengracht-Syndrome (no particular screening necessary).
  -  Known or expected contraindication against study medication.
  -  Participation in other studies during 30 days before study entry.
  -  Prior myocardial infarction, severe renal insufficiency (creatinine clearance £30ml/min).
  -  Previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment and no sign of disease during 5 years).
  -  Known or suspected cerebral metastasis.
  -  History of inflammatory bowel disease. Symptomatic peritoneal carcinomatosis.
  -  Drug or alcohol abuse. Lack of adequate legal capacity.
  -  Breast-feeding or pregnant women.
  -  Concurrent medication with Sorivudine and analoga, anticoagulation with Cumarine or derivatives.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Colorectal Cancer Screening Intervention Trial

Summary: Colorectal cancer is the second deadliest among cancers and disproportionately affects African Americans. The Colorectal Cancer Screening Intervention Trial(CCSIT) project has as its goal to test three interventions designed to increase screening rates among medically underserved African Americans in the Metropolitan Atlanta area. It is designed to increase awareness of modifiable risk factors and promote the benefits of screening as a means of early detection of colorectal cancer. mportance of being screened for colorectal cancer,African Americans continue to be disproportionately affected by this disease. The Colorectal Cancer Screening

Detailed description: Despite increased awareness of the importance of being screened for colorectal cancer, African Americans continue to be disproportionately affected by this disease. The Colorectal Cancer Screening Intervention Trial (CCSIT) is designed to test and expand a public health intervention that combines social marketing and community-coalition building efforts.
  The purpose of this study is to 1) evaluate the effects of three different approaches on knowledge, attitudes and beliefs (KABs) about colorectal cancer; 2) to examine the effects of three different approaches to adherence to screening guidelines and 3) to evaluate the independent role of setting on screening practices.
  Participants age 50 and over are recruited from churches, clinics and senior sites which allows us to examine the impact of setting on participant recruitment and changes to KAB. Pre and post questionnaires are administered to determine the knowledge attitudes and behaviors (KAB) related to screening and to measure psychosocial parameters (self-esteem, perceived stress and social support). These persons are randomized into one of four groups, the control group and three intervention arms: (1) one-on-one counseling sessions, (2) small group educational sessions and (3) financial incentives interventions where out of pocket cost for screening is reimbursed. The counseling and educational interventions incorporate the Health Belief Model and Social Learning Theory.

Eligibility: Inclusion Criteria:
  -  African American
  -  Previously not screened for colorectal cancer according to ACS guidelines
  -  Reside in Fulton,,Gwinett,Cobb,Clayton and DeKalb counties
  -  50 years of age or older
  Exclusion Criteria:
  -  Non-African American
  -  Less than 50 years of age
  -  Previously screened consistent with ACS guideline

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Aspirin/Folate Prevention of Large Bowel Polyps

Summary: This is a randomized controlled trial of aspirin and/or folate supplementation for the prevention of the recurrence of neoplastic polyps (adenomas) of the large bowel.

Detailed description: This is a randomized controlled trial of aspirin and/or folate supplementation for the prevention of the recurrence of neoplastic polyps (adenomas) of the large bowel among subjects with a recent history of these tumors. The study is a randomized, double-blind, placebo-controlled trial with a 2 x 3 factorial design.

Eligibility: Inclusion Criteria:
  1. One neoplastic polyp removed within three months of study entry or within 16 months of study entry if over 1 cm in size or if subject has had a lifetime history of at least two polyps, with the entire large bowel seen by colonoscopy to be free of further polyps within 3 months of entry.
  2. An ability and willingness to follow the study protocol, as indicated by the subject's giving informed consent to participate.
  3. Good general health, with no severely debilitating diseases or active malignancy that might compromise the patient's ability to complete the study.
  4. Anticipated colonoscopic follow-up three years after the qualifying colonoscopy.
  5. Age between 21 and 80 years at the time of the intake colonoscopy.
  6. For women of childbearing potential, agreement to use effective birth control for the duration of the study.
  7. Intent not to take aspirin or aspirin-containing products, NSAIDs or folic acid for the length of the study unless required by a physician.
  8. Not randomized previously or currently in a chemoprevention trial, except for the: “Nutritional Prevention of Large Bowel Polyps” Study (Polyps Prevention Study I); and brief participation in the “VA Cooperative Study” with no continuing involvement.
  Exclusion Criteria:
  1. Invasive carcinoma in any colonic polyp removed.
  2. Familial colonic polyposis syndromes.
  3. Ulcerative colitis or Crohn's disease.
  4. Malabsorption syndrome (e.g. pancreatic insufficiency).
  5. Large bowel resection for any reason.
  6. Diagnosed narcotic or alcohol dependence
  7. Contraindication to aspirin use, including:
  1. documented peptic ulcer disease in the past 20 years
  2. aspirin sensitivity
  3. bleeding diathesis, including hemorrhagic stroke
  8. Likelihood of NSAID use
  1. recurring arthritis or other musculo-skeletal problems
  2. frequent NSAID use in 5 years preceding
  3. history of stroke or TIAs
  4. history of angina or myocardial infarction
  5. desire to take aspirin for the prevention of cardiovascular disease
  9. Required or contraindicated folic acid use pernicious anemia or folic acid deficiency
  10. Pregnancy or lactation.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX)

Summary: The primary purpose of this study is to compare the efficacy of AZD2171 in combination with FOLFOX to the efficacy of bevacizumab in combination with FOLFOX, in the second-line treatment of patients with metastatic colorectal cancer


Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of colon or rectal cancer,
  -  Received prior systemic therapy for cancer,
  -  Cancer must have progressed during or after first treatment
  Exclusion Criteria:
  -  Prior treatment with a VEGF inhibitor,
  -  Poorly controlled hypertension

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Randomized Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Colon Carcinoma Dukes C

Summary: This clinical investigation examined the effectivity 5-fluorouracil, of adding levamisol or interferon to 5-fluorouracil, and of a 5-fluorouracil/levamisol/interferon triple combination, in terms of recurrence-free and overall survival in curatively operable colon carcinoma Stage III.


Eligibility: Inclusion Criteria:
  -  Patients with histologically verified, curatively operated colon carcinoma Stage III (R0, T1-4, N1-3, M0)
  -  Age: less than 80 years
  -  WHO Performace Status > 2
  -  Adequate bone marrow reserve
  -  Informed consent
  Exclusion Criteria:
  -  Rectal cancer
  -  R1, R2, carcinosis peritonei
  -  Start of chemo- or chemo-immunotherapy > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
  -  Serious concomitant disease, in particular chronically inflammatory large intestine, cardiopathic disease, malignant second carcinoma

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

Summary: This clinical investigation examined the influence of cytostatic chemotherapy with 5-fluorouracil, modulated by biologically active leucovorin, on patients’ survival time following surgery for colon carcinoma Stage II.


Eligibility: Inclusion Criteria:
  -  Patients with histologically verified, operable colon carcinoma Stage II (RO, T3-4, N0, M0)
  -  Age: less than 80 years
  -  WHO Performance > 2
  -  Adequate bone marrow reserve, renal and hepatic functions
  -  Informed consent
  Exclusion Criteria:
  -  Rectal cancer
  -  R1or R2 resection; carcinosis peritonei
  -  Start of treatment > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
  -  Serious concomitant disease, in particular chronically inflammatory large intestine, cardiopathic or metabolic disease, malignant second carcinoma

Relevance to patient case: not relevant