NCT00143403已完成3 期
Multi-Centre Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FU/FA Infusional Regimen To The Same 5-FU/FA Infusional Regimen Alone, As Adjuvant Treatment After Resection Of Liver Metastases For Colorectal Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 321
- 试验地点
- 1
- 主要终点
- Disease Free Survival (DFS)
研究概览
简要总结
To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen, compared to 5-FU/FA alone.
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 with complete resection of primary tumour.
- •Complete surgical resection (R0) of the liver metastasis(es) within a minimum of 3 weeks, and a maximum of 8 weeks prior to the first study treatment infusion.
- •Exclusively hepatic metastasis (es) : absence of bone, lung and brain metastases.
排除标准
- •Prior hepatic radiation or resection.
- •Prior radiofrequency ablation or cryoablation Incomplete surgical resection of liver metastasis (es).
- •Prior chemotherapy for metastatic disease.
研究组 & 干预措施
1
Experimental
干预措施: Irinotecan + 5 FU + folinic acid (Drug)
2
Active Comparator
干预措施: Folinic Acid + 5 FU (Drug)
结局指标
主要结局
Disease Free Survival (DFS)
时间窗: last tumor assessment date or cut-off date, whichever is earlier.
time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.
次要结局
- Overall Survival Rates(Median follow-up time (42 months))
研究者
研究点 (1)
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