Multicenter Phase III Randomized Study of FOLFIRI Plus Bevacizumab Following or Not by a Maintenance Therapy With Bevacizumab in Patients With Non-Pretreated Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 492
- 试验地点
- 58
- 主要终点
- Disease-control duration
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not yet known whether giving more than one drug (combination chemotherapy) is more effective when given with or without bevacizumab in treating patients with metastatic colorectal cancer.
PURPOSE: This randomized phase III trial is studying giving combination chemotherapy with or without bevacizumab to see how well it works in treating patients with metastatic colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Compare disease-control duration in patients with metastatic colorectal cancer receiving FOLFIRI chemotherapy in combination with bevacizumab with or without bevacizumab maintenance therapy.
Secondary
- Determine objective response rate.
- Determine non-hematologic grade 3-4 (except alopecia) toxicity rate.
- Determine overall toxicity rate.
- Determine duration of chemotherapy-free interval.
- Determine progression-free survival.
- Determine overall survival.
- Determine time-to-treatment failure.
- Determine quality of life (EORTC QLQ-C30).
- Complete geriatric evaluation.
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 120 Years（Adult, 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
Maintenance with bevacizumab
FOLFIRI + Avastin and during the chemotherapy-free interval maintenance with bevacizumab
干预措施: bevacizumab (Biological)
Maintenance with bevacizumab
FOLFIRI + Avastin and during the chemotherapy-free interval maintenance with bevacizumab
干预措施: FOLFIRI regimen (Drug)
Maintenance with bevacizumab
FOLFIRI + Avastin and during the chemotherapy-free interval maintenance with bevacizumab
干预措施: fluorouracil (Drug)
Maintenance with bevacizumab
FOLFIRI + Avastin and during the chemotherapy-free interval maintenance with bevacizumab
干预措施: irinotecan hydrochloride (Drug)
Maintenance with bevacizumab
FOLFIRI + Avastin and during the chemotherapy-free interval maintenance with bevacizumab
干预措施: leucovorin calcium (Drug)
No maintenance with bevacizumab
FOLFIRI + Avastin and during the chemotherapy-free interval NO maintenance
干预措施: bevacizumab (Biological)
No maintenance with bevacizumab
FOLFIRI + Avastin and during the chemotherapy-free interval NO maintenance
干预措施: FOLFIRI regimen (Drug)
No maintenance with bevacizumab
FOLFIRI + Avastin and during the chemotherapy-free interval NO maintenance
干预措施: fluorouracil (Drug)
No maintenance with bevacizumab
FOLFIRI + Avastin and during the chemotherapy-free interval NO maintenance
干预措施: irinotecan hydrochloride (Drug)
No maintenance with bevacizumab
FOLFIRI + Avastin and during the chemotherapy-free interval NO maintenance
干预措施: leucovorin calcium (Drug)
结局指标
主要结局
Disease-control duration
时间窗: one year after last patient included
次要结局
- Progression-free survival(one year after last patient is included)
- Rate of non-hematologic grade 3-4 toxicities (except alopecia)(one year after last patient is included)
- Overall toxicity rate(one year after last patient is included)
- Time-to-treatment failure(one year after last patient is included)
- Overall survival(one and 2 year after last patient is included)
- Geriatric evaluation(one year after last patient is included)
- Objective response rate(one year after last patient is included)
- Duration of chemotherapy-free interval(one year after last patient is included)
- Quality of life as assessed by EORTC QLQ-C30(one year after last patient is included)