NCT00265824已完成3 期
Phase III Study of an Optimized Chemotherapy Followed by Maintenance With Bevacizumab Strategy With or Without Erlotinib in Unresectable Metastatic Colorectal Cancer. DREAM OPTIMOX 3. C04-2
GERCOR - Multidisciplinary Oncology Cooperative Group41 个研究点 分布在 3 个国家目标入组 700 人开始时间: 2005年5月最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 试验地点
- 41
- 主要终点
- Progression-free survival during maintenance therapy
研究概览
简要总结
PURPOSE: This randomized phase III trial is studying maintenance therapy with bevacizumab alone after an induction therapy combining bevacizumab+chemotherapy to see how well they work compared to maintenance therapy with bevacizumab+erlotinib alone after an induction therapy combining bevacizumab+chemotherapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Compare Progression-free survival during maintenance period ("Maintenance PFS")in patients with unresectable metastatic colorectal cancer.
Secondary
- Compare the duration of disease control 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.
- Compare the occurrence of secondary surgery in patients treated with these regimens.
- Compare the chemotherapy-free intervals and response rates in 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
- 18 Years 至 80 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
bevacizumab alone
Active Comparator
干预措施: bevacizumab (Drug)
Bevacizumab + erlotinib
Experimental
干预措施: bevacizumab, erlotinib (Drug)
结局指标
主要结局
Progression-free survival during maintenance therapy
时间窗: Tumor evaluation every 2 months
次要结局
未报告次要终点
研究者
研究点 (41)
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