Exploration of New Biologic Factors' Predictive Value , Especially Circulating VE-cadherin in Metastatic Colorectal Adenocarcinoma Patients Treated With Bevacizumab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 4
- 主要终点
- Response rate to treatment
研究概览
简要总结
It is a prospective, non-randomized, monocentric study. The purpose of the study is to assess the predictive value of VE-cadherin on the objective tumor response.
Biological factors will be correlated to clinical outcome measures.
100 patients treated with bevacizumab for a metastatic colorectal adenocarcinoma will be enrolled.
Patients will be followed every 10 weeks until progression in spite of bevacizumab or until they stop bevacizumab because of toxicity.
Bevacizumab will be administered according to investigators appreciation.
Blood samples will be collected at enrollment, at second bevacizumab's administration and every 10 weeks until progression, or until patients stop bevacizumab because of toxicity or until one year at most in case that patients still receive bevacizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient with a metastatic colorectal cancer proved histologically and treated with bevacizumab in first line.
- •At least one extra-osseous, non-irradiated, measurable site (>= 10 mm with spiral CT).
- •No prior radiotherapy treatment unless treatment is over for at least 4 weeks.
- •Adult patients.
- •Life expectancy greater than 3 months.
- •Mandatory affiliation with a healthy security insurance.
- •Signed written informed consent.
排除标准
- •Prior chemotherapy for the metastatic cancer.
- •Prior bevacizumab treatment.
- •Other current cancer or previous cancer detected in the last 5 years that can be linked to the current disease.
- •Patient deprived of freedom.
- •Pregnant or lactating women.
结局指标
主要结局
Response rate to treatment
时间窗: Up to 1 year at most
A 30% response rate (complete or partial response) to treatment is expected. The response will be assessed according to RECIST criteria. This primary outcome measure is defined by the observation of at least one objective response during the treatment. This outcome measure will be correlated to biological factors.
次要结局
- Clinical benefit(At progression or up to 1 year at most)
- Evaluation of overall survival(From the beginning of treatment to death or last available information)
- Evaluation of tumoral markers(At progression with bevacizumab or up to 1 year of follow-up at most)
- Evaluation of vascular toxicities(Up to 1 year)
- Evaluation of progression-free survival(From the beginning of treatment to progression, death or last available information)