EUCTR2013-005435-24-NL进行中（未招募）1 期
Treatment strategies in colorectal cancer patients with initially irresectable liver-only metastases. CAIRO5 a randomized phase 3 study of the Dutch Colorectal Cancer Group (DCCG) - CAIRO5
Dutch Colorectal Cancer Group0 个研究点目标入组 584 人开始时间: 2014年2月4日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 584
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Histologically proven colorectal cancer
- •-Irresectable metastases confined to the liver according to CT scan, obtained = 4 weeks prior to randomization. Irresectability should be confirmed by the panel. Patients with small (= 1 cm) extrahepatic lesions that are not clearly suspicious of metastases are eligible.
- •-Adequate tumor tissue available for central assessment of RAS/BRAF mutation status
- •-WHO performance status 0-2 (Karnofsky performance = 70)
- •-Age = 18 years
- •-No contraindications for liver surgery
- •-in case of synchronous metastatses: resectable primary tumor, or adequate clinical recovery in case of immediate surgery of primary tumor
- •-Adequate organ functions, as determined by normal bone marrow function (Hb ³ 6.0 mmol/L, absolute neutrophil count ³ 1.5 x 109/L, platelets ³ 100 x 109/L), renal function (serum creatinine = 1.5x ULN and creatinine clearance, Cockroft formula, ³ 30 ml/min), liver function (serum bilirubin = 2 x ULN, serum transaminases = 5x ULN)
- •-Life expectancy > 12 weeks
- •-Expected adequacy of follow-up
- •-Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 292
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 292
排除标准
- •-Extrahepatic metastases, with the exception of small (= 1 cm) extrahepatic lesions that are not clearly suspicious of metastases
- •-Irresectable primary tumor, or resectable tumor requiring immediate surgery
- •-Serious comorbidity or any other condition preventing the safe administration of study treatment (including both systemic treatment and surgery)
- •-Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months of randomization
- •-Uncontrolled hypertension, or unsatisfactory blood pressure control with =3 antihypertensive drugs
- •-Previous systemic treatment for metastatic disease; previous adjuvant treatment is allowed if completed = 6 months prior to randomization
- •-Previous intolerance of study drugs in the adjuvant setting
- •-Pregnant or lactating women
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