NCT00284258已完成2 期
Phase II/III Trial of CPT-11/5-FU/l-LV (FOLFIRI) Versus CPT-11/TS-1 (IRIS) as Second Line Chemotherapy of Unresectable Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 426
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
This study is designed as Phase II/III. Phase II is aimed to evaluate safety and efficacy of IRIS, and feasibility of FOLFIRI. Phase III is aimed to verify inferiority of the progression free survival of IRIS in comparison with FOLFIRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed colorectal cancer
- •Locally advanced and/or metastatic colorectal cancer
- •Have prior chemotherapy as first line treatment
- •No prior irinotecan administration
- •Able to take oral medication
- •Age 20 to 75
- •Performance status 0 or 1 (ECOG)
- •WBC 3,000-12,000 / mm^3
- •Platelet ≥100,000 / mm^3
- •AST and ALT ≤ 100 IU/L
- •Creatinine ≤ 1.2 mg/dL
- •Bilirubin ≤ 1.5 mg/dL
排除标准
- •Prior radio therapy for colorectal cancer
- •Other malignancies in the past 5 years
- •Serious illness or medical condition
研究组 & 干预措施
1
Experimental
CPT-11 and TS-1
干预措施: CPT-11 and TS-1 (Drug)
2
Active Comparator
CPT-11, 5-FU and l-LV
干预措施: CPT-11, 5-FU and l-LV (Drug)
结局指标
主要结局
Progression free survival
时间窗: every course for first three courses, then every other course
次要结局
- Over all survival, Response rate, Adverse event, Medical economy(adverse events will be collected during treatment)
研究者
研究点 (1)
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相似试验
未知
2 期
Phase II/III Trial of CPT-11/5-FU/l-LV (FOLFIRI) Versus CPT-11/TS-1 (IRIS) as Second Line Chemotherapy of Unresectable Colorectal CancerJPRN-jRCT1080220199Taiho Pharmaceutical Co., Ltd. DAIICHI SANKYO Co., Ltd.
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