ISRCTN34968597已完成不适用
Safety assessment of treatment with cetuximab in metastatic colorectal cancer patients: An observational study
Institute of Oncology Ljubljana (Slovenia)0 个研究点目标入组 250 人开始时间: 2010年2月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
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. ECOG performance score 0- 2
- •6. Life expectancy of at least 3 months
- •7. Adequate haematological function (ANC =1.5 x 10/9L, platelets = 100 x 10/9/L, Hb = 90g/L)
- •8. Adequate liver function (serum bilirubin = 1.5 x ULN, AST/ALP = 2.5 x ULN, in case of liver metastases < 5 x ULN)
- •9. Adequate renal function (calculated creatinine clearance = 50 mL/min)
排除标准
- •1. ECOG performance score > 2
- •2. Prior treatment with cetuximab
- •3. Participation in another clinical trial within 30 days prior to entering this study
- •4. Known hypersensitivity to any of the study drugs
- •5. Clinically significant cardiovascular disease
- •5.1. Myocardial infarction = 6 months before treatment start
- •5.2. Unstable angina
- •5.3. Uncontrolled hypertension
- •5.4. Arrhythmia requiring medication
- •5. Clinical evidence or confirmed brain metastases
- •6. Psychiatric disability to be clinically significant precluding informed consent
- •7. Evidence of any other disease, 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
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