A Multicenter, Non-interventional, Post-authorization Study to Observe in Daily Clinical Practice the Treatment Duration of Patients Treated With Avastin (Bevacizumab) in 1st Line mCRC in Belgium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 主要终点
- Duration of Bevacizumab Treatment
研究概览
简要总结
This observational study will assess the treatment duration, progression-free survival, reason for stopping treatment and patient and tumor characteristics of bevacizumab [Avastin] treatment in patients with metastatic colorectal cancer. Data will be collected for approximately 34 months. The target sample size is >300 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
- •adult patients =/<18 years of age
- •metastatic colorectal cancer
- •patients for whom the physician has prescribed bevacizumab [Avastin] for the treatment of 1st line metastatic colorectal cancer
- •patients, who have given written informed consent
排除标准
- •hypersensitivity to recombinant human or humanised antibodies
- •pregnancy or breast-feeding
研究组 & 干预措施
Cohort
干预措施: bevacizumab [Avastin] (Drug)
结局指标
主要结局
Duration of Bevacizumab Treatment
时间窗: Baseline up to end of treatment (up to approximately 3 years)
Duration of bevacizumab treatment (in months) was defined as: (last treatment date - first treatment date plus \[+\] 1)/30.44. Duration of treatment was estimated using Kaplan-Meier method. Results are reported as per age groups (\<70 years and greater than or equal to \[≥\] 70 years) as well as for overall participants.
次要结局
- Progression-Free Survival (PFS)(Baseline up to disease progression or death (up to approximately 3 years))
- Percentage of Participants With Best Overall Response(Baseline up to disease progression or death (up to approximately 3 years))
- Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status(Baseline up to Cycle 51 (1 cycle = 21 days))