NCT02305615已完成不适用
Hungarian Multicenter Non-Interventional Study of Continued Avastin (Bevacizumab) Plus Chemotherapy Until First Progression Following Induction Treatment With Chemotherapy Doublet Plus Avastin in First Line Treatment of Patients With Metastatic Colorectal Carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 22
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This prospective, multicenter, observational study will investigate the effectiveness and safety of bevacizumab in routine clinical practice in participants with metastatic CRC. Participants are to have initiated first-line treatment with fluoropyrimidine-based doublet chemotherapy plus bevacizumab according to the bevacizumab Summary of Product Characteristics (SmPC).
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 CRC with metastatic lesion
- •Participants having initiated first-line treatment with fluoropyrimidine-based doublet chemotherapy plus bevacizumab according to bevacizumab SmPC
- •Participants who previously received a minimum 9 cycles of 5-FU-based or a minimum 6 cycles of capecitabine-based induction doublet chemotherapy (i.e. 5-FU or capecitabine + oxaliplatin or irinotecan) plus bevacizumab
- •Disease evaluation showed stable disease, partial response, or complete response according to RECIST within one month
排除标准
- •Contraindication to receive bevacizumab according to the bevacizumab SmPC
- •Participants who received more than 10 cycles of 5-FU-based or more than 7 cycles of capecitabine-based induction doublet chemotherapy plus bevacizumab
- •Pregnant or lactating women
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From enrollment to the first documented progression or death from any cause, whichever occurs first (maximum up to 36 months)
次要结局
- PFS on First-Line Therapy(From first dose of bevacizumab first-line treatment up to the first documented progression or death from any cause, whichever occurs first (maximum up to 36 months))
- Percentage of Participants who were Alive at 1 Year(From enrollment up to death from any cause, maximum up to 1 year)
- Duration of Bevacizumab Plus Chemotherapy Treatment(From Baseline up to 36 months)
- Percentage of Participants with Best Overall Response Assessed by Treating Physicians Using Response Evaluation Criteria in Solid Tumors (RECIST)(From Baseline up to 36 months)
- Percentage of Participants with Reason for Bevacizumab Plus Chemotherapy Treatment Discontinuation(From enrollment to the treatment discontinuation (maximum up to 36 months))
- Percentage of Participants with Protocol Defined Baseline Participant and Disease Characteristics(Baseline)
- Percentage of Participants with Adverse Events (AEs) and Serious AEs(From Baseline up to 36 months)
研究者
研究点 (22)
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