Etude de Cohorte évaluant l'Impact de l'Association chimiothérapie et Bevacizumab en 1ère Ligne du Cancer Colorectal métastatique Sur la qualité de Vie Relative Des Patients. Etude COBEQOL
试验速览
- 阶段
- 不适用
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- time to health related quality of life score deterioration (targeted dimensions of EORTC QLQC30 : global health, fatigue, emotional functioning)
研究概览
简要总结
The primary aim of this french multicenter national study is to assess and compare time to quality of life score deterioration (targeted dimensions : global health, fatigue and emotional functionning of EORTC QLQC30 according to the first line chemotherapy associated with bevacizumab in metastatic colorectal patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •age> 18years
- •metastatic colorectal cancer (non resectable)
- •1st chemotherapy including bevacizuman
排除标准
- •treatment contre-indication
研究组 & 干预措施
irinotecan based chemotherapy
patients having a 1st line doublet chemotherapy including irinotecan
干预措施: Bevacizumab (Drug)
oxaliplatin based chemotherapy
patients having a 1st line doublet chemotherapy including oxaliplatin
干预措施: Bevacizumab (Drug)
triplet chemotherapy
patient having a 1st line triplet chemotherapy including oxaliplatin / irinotecan this cohort was added while primary objective was to compare doublet chemotherapy
干预措施: Bevacizumab (Drug)
结局指标
主要结局
time to health related quality of life score deterioration (targeted dimensions of EORTC QLQC30 : global health, fatigue, emotional functioning)
时间窗: 1 year
The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients.
次要结局
- treatment preference(1 year)
- Overall survival(2 years)
- Progression Free Survival(1 year)
- INT PATSAT32(1 year)
- time to health related quality of life score deterioration (non targeted dimensions of EORTC QLQC30 and CR 29)(1 year)
- quality-adjusted life years (QALYs) using EQ5D(1 year)