ISRCTN10604174已完成未知
The influence of mutation status in KRAS and BRAF gene according to the classical histological parameters of tumor as a predictive factor of the aggressive course of disease in metastatic colorectal cancer: a single centre, prospective, cohort trial
Institute of Oncology Ljubljana (Slovenia)0 个研究点目标入组 400 人开始时间: 2010年12月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Written informed consent
- •2. Histologically confirmed colorectal cancer
- •3. Diagnosis of metastatic disease
- •4. Age 18 to 75 years
- •5. Eastern Cooperative Oncology Group (ECOG) performance score 0 - 2
- •6. Life expectancy of at least 3 months
- •7. Primary tumor with described histological features
- •8. Histology available for further analysis and molecular diagnostics
- •9. Determination of BRAF mutations in KRAS gene before starting treatment
- •10. Adequate haematological function (ANC greater than or equal to 1.5 x 10/9L, platelets greater than or equal to 100 x 10/9/L, Hb greater than or equal to 90 g/L)
- •11. Adequate liver function (serum bilirubin less than or equal to 1.5 x ULN, AST/ALP less than or equal to 2.5 x ULN
- •12. In case of liver metastases less than 5 x ULN), adequate renal function (calculated creatinine clearance greater than or equal to 50 mL/min)
排除标准
- •1. ECOG performance score greater than 2
- •2. Participation in another clinical trial within 30 days prior to entering this study
- •3. Known hypersensitivity to any of the study drugs
- •4. Clinically significant cardiovascular disease (myocardial infarction less than or equal to 6 months before treatment start
- •5. Unstable angina
- •6. Uncontrolled hypertension
- •7. Arrhythmia requiring medication
- •8. Clinically significant renal disease (creatinine clearance less than 30 ml/min)
- •9. Liver cirrhosis Child B and C
- •10. Psychiatric disability to be clinically significant precluding informed consent
- •11. Evidence of any other disease
- •12. Metabolic dysfunction or laboratory findings, which give a suspicion of a disease or condition that contraindicates the use of any investigational drugs or means a higher risk for treatment-related complications
研究者
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