NCT00208260已完成2 期
Randomized Phase II Trial Followed by Phase III Trial With Molecular Biology Study, Comparing a Standard Bi-therapy vs 3 Arms of Intensified Chemotherapy in Patients With Unresectable or Not Optimally Resectable Colorectal Cancer Liver Metastases.
Institut du Cancer de Montpellier - Val d'Aurelle1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2004年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Response
研究概览
简要总结
Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven adenocarcinoma of the colon or rectum without previous resection, or clinically asymptomatic (with or without stent)
- •Hepatic unresectable metastases R0: due to close vascular contact, or due to liver remaining mass less than 25 to 30 % of functional liver.
- •Not optimally resectable metastases
- •Extra-hepatic disease will be accepted in case of: asymptomatic primary tumour or tumor requiring no urgent surgery (in less than 3 months); three of less than three lung metastases (thoracic scan diameter less than 2 cm) and potentially respectable.
- •Synchronous and metachronous hepatic metastases
- •WHO performance status 0-1
- •Adjuvant chemotherapy allowed, except oxaliplatin and irinotecan based combination.
- •No prior treatment of the liver metastases, whatever.
- •Life expectancy equal or more than 3 months
排除标准
- 未提供
研究组 & 干预措施
A
Active Comparator
FOLFIRI
干预措施: FOLFIRI (Drug)
B
Active Comparator
FOLFOX-4
干预措施: FOLFOX-4 (Drug)
C
Experimental
FOLFIRI-HD
干预措施: FOLFIRI-HD (Drug)
D
Experimental
FOLFOX-7
干预措施: FOLFOX-7 (Drug)
E
Experimental
FOLFIRINOX
干预措施: FOLFIRINOX (Drug)
结局指标
主要结局
Response
时间窗: end of chemotherapy
次要结局
- Safety(during study treatment)
- Survival(2 years)
- Secondary resection(surgery after chemotherapy)
研究者
研究点 (1)
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