Bevacizumab Maintenance Versus no Maintenance After Stop of First-line Chemotherapy in Patients With Metastatic Colorectal Cancer. A Randomized Multicenter Phase III Non-inferiority Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 265
- 试验地点
- 58
- 主要终点
- Time to progression (TTP)
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving bevacizumab as maintenance therapy is more effective than observation in treating patients with colorectal cancer.
PURPOSE: This randomized phase III trial is studying bevacizumab to see how well it works in treating patients who have undergone first-line therapy for metastatic colorectal cancer.
详细描述
OBJECTIVES:
Primary
- To demonstrate that time to progression (TTP) without further treatment is not inferior to TTP with maintenance therapy comprising bevacizumab in patients with metastatic colorectal cancer and stable or responding disease after completion of standard first-line chemotherapy/bevacizumab treatment.
Secondary
- To evaluate the safety of bevacizumab maintenance therapy in these patients.
- To assess the long-term cost implications of prolonged treatment with bevacizumab.
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 —（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
结局指标
主要结局
Time to progression (TTP)
时间窗: From randomization until documented progressive disease or death due to tumor.
TTP will be calculated from randomization until documented PD or death due to tumor.
次要结局
- Overall survival (OS)(OS will be calculated from start of first-line treatment until death. Additionally, OS will be calculated from randomization until death.)
- Progression-free survival (PFS)(From start of first-line treatment until documented PD or death, whichever occurs first.)
- Adverse events (AE)(Predefined AEs and AEs ≥ grade 3 will be assessed according to NCI CTCAE v3.0.)
- Long-term bevacizumab treatment costs(Estimated for the time period between randomization and the end of the follow-up phase (lasting maximal 5 years).)