Randomized Study of Classic vs Simplified Leucovorin Calcium and Fluorouracil With or Without Irinotecan in Patients Aged At Least 75 Years With Advanced Colorectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 282
- 试验地点
- 77
- 主要终点
- Progression Free Survival (survie sans progression)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) in different doses or combinations may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer.
PURPOSE: This randomized clinical trial is studying how well fluorouracil works together with leucovorin with or without irinotecan in treating older patients with metastatic colorectal cancer .
详细描述
OBJECTIVES:
Primary
- Compare the progression-free survival of elderly patients with unresectable metastatic colorectal cancer treated with 1 of 2 different chemotherapy regimens comprising fluorouracil and leucovorin calcium with vs without irinotecan hydrochloride.
Secondary
- Compare the tumor response rate and overall survival of patients treated with these regimens.
- Compare the tolerability of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
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
- 75 Years 至 120 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LV5FU2 simplifié
LV5FU2 simplifié
干预措施: leucovorin calcium (Drug)
LV5FU2 classique
LV5FU2 classique
干预措施: fluorouracil (Drug)
LV5FU2 classique
LV5FU2 classique
干预措施: leucovorin calcium (Drug)
LV5FU2 classique + irinotécan
LV5FU2 classique + irinotécan
干预措施: fluorouracil (Drug)
LV5FU2 classique + irinotécan
LV5FU2 classique + irinotécan
干预措施: irinotecan hydrochloride (Drug)
LV5FU2 classique + irinotécan
LV5FU2 classique + irinotécan
干预措施: leucovorin calcium (Drug)
LV5FU2 simplifié
LV5FU2 simplifié
干预措施: fluorouracil (Drug)
LV5FU2 simplifié+ irinotécan
LV5FU2 simplifié + irinotécan
干预措施: fluorouracil (Drug)
LV5FU2 simplifié+ irinotécan
LV5FU2 simplifié + irinotécan
干预措施: irinotecan hydrochloride (Drug)
LV5FU2 simplifié+ irinotécan
LV5FU2 simplifié + irinotécan
干预措施: leucovorin calcium (Drug)
结局指标
主要结局
Progression Free Survival (survie sans progression)
时间窗: 2011
survie sans progression
次要结局
- Overall Survival (survie globale)(2011)