An Open-Label, Multicenter, Non-Interventional, Observational Study To Assess The Effect Of First Line Bevacizumab Treatment With Fluoropyrimidine-Based Chemotherapy (CTX) In Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 351
- 试验地点
- 9
- 主要终点
- Overall survival from the time of starting first-line therapy
研究概览
简要总结
This multicenter observational study will evaluate the efficacy and safety of first-line bevacizumab (Avastin) in combination with fluoropyrimidine-based chemotherapy in participants with metastatic colorectal cancer (mCRC). Participants for whom the treating physician has decided to initiate first-line fluoropyrimidine based chemotherapy in combination with bevacizumab will be observed for approximately 4 years.
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
- •Participants with histologically confirmed metastatic colorectal cancer who will receive bevacizumab in combination with first-line fluoropyrimidine-based chemotherapy
排除标准
- •Participants not qualified for bevacizumab treatment according to the local label
研究组 & 干预措施
mCRC Participants
mCRC participant will receive bevacizumab as per approved label with the approved first-line fluoropyrimidine based chemotherapy, as per physician discretion. The protocol does not specify the chemotherapy regimen to be used, the choice of chemotherapy will be at the discretion of treating physician.
干预措施: Bevacizumab (Drug)
mCRC Participants
mCRC participant will receive bevacizumab as per approved label with the approved first-line fluoropyrimidine based chemotherapy, as per physician discretion. The protocol does not specify the chemotherapy regimen to be used, the choice of chemotherapy will be at the discretion of treating physician.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Overall survival from the time of starting first-line therapy
时间窗: Start of first line therapy until death (up to approximately 4 years)
次要结局
- Progression-free survival from the time of starting first-line therapy, assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria(Start of first line therapy until death (up to approximately 4 years))
- Percentage of participants with best overall response, assessed according to RECIST v.1.1 criteria(Start of first line therapy until death (up to approximately 4 years))
- Percentage of participants with liver resection(up to approximately 4 years)
- Number of participants with adverse events(up to approximately 4 years)