Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 9
- 主要终点
- To demonstrate that maintenance treatment with bevacizumab + erlotinib following first line chemo- and anti-angiogenetic therapy results in a significant increase in progression free survival (PFS) compared to treatment with only bevacizumab.
研究概览
简要总结
Patients with metastatic colorectal cancer will be treated with chemotherapy according to investigators choice. In addition to chemotherapy treatment, treatment with bevacizumab will be given concomitantly. This treatment will continue during 18 weeks. Meanwhile, the patients KRAS status will be tested. After having fulfilled these 18 weeks of induction treatment, patients who has responded (complete response/partial response versus stable disease) will be randomized to maintenance treatment. Patients with KRAS WT will be randomized to either bevacizumab alone, or to bevacizumab and erlotinib. Patient with KRAS mutation will be randomized to either bevacizumab, or metronomic capecitabine. Translational research is performed, with purpose to find predictive factors in blood and tumor tissue.
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
- •Untreated metastatic colorectal carcinoma
- •Age 18 yrs or over
- •Measurable disease according to Response Evaluation Criteria in solid Tumors (RECIST criteria)
- •ECOG performance status 0 or 1
- •Life expectancy more than 3 months
- •Adequate haematological, renal and liver function
- •Tumor tissue available for determination of KRAS mutational status
- •Blood sample and paraffin embedded tumor tissue for translational research
排除标准
- •Adjuvant therapy within 6 months
- •CNS metastases
- •Clinically significant atherosclerotic vascular disease
研究组 & 干预措施
bevacizumab (KRAS mutated)
干预措施: bevacizumab (Drug)
bevacizumab and erlotinib (KRAS WT)
干预措施: bevacizumab, erlotinib (Drug)
bevacizumab (KRAS WT)
干预措施: bevacizumab (Drug)
low dose capecitabine (KRAS mutated)
干预措施: low dose capecitabine (Drug)
结局指标
主要结局
To demonstrate that maintenance treatment with bevacizumab + erlotinib following first line chemo- and anti-angiogenetic therapy results in a significant increase in progression free survival (PFS) compared to treatment with only bevacizumab.
时间窗: 3 years
次要结局
- To explore the activity of bevacizumab and low dose metronomic capecitabine in patients with KRAS mutated tumors.(3 years)