Avastin ® First Line and Where Applicable Beyond First Progression With Metastatic Colorectal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,003
- 主要终点
- Median Progression-Free Survival Time in Defined Participant Subgroups as Assessed by Response Evaluation Criteria In Solid Tumors (RECIST)
研究概览
简要总结
This observational multicenter study will evaluate the differences in progression-free survival defined in specific subgroups of participants with metastatic colorectal cancer receiving bevacizumab (Avastin). Further, safety and efficacy in daily routine will be assessed.
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 metastatic colorectal cancer where physician has decided to give a first-line, fluoro-pyrimidine-based combination therapy with bevacizumab according to Summary of Product Characteristics (SmPC)
排除标准
- •Contraindications for bevacizumab according to SmPC
研究组 & 干预措施
Metastatic Colorectal Cancer Participants
Administration of treatment will be as used in normal daily routine under local labelling in 4 subgroups- participants with liver and/or lung metastases, potentially resectable after a response to a systemic therapy and clinically operable; participants with tumor related symptoms, risks for complications or fast progression for whom quick proliferation control is needed; "asymptomatic" participants (indolent tumor) without the option of a metastases resection (no pressure for remission) for whom the aim of the therapy is proliferation control and participants without classification.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Median Progression-Free Survival Time in Defined Participant Subgroups as Assessed by Response Evaluation Criteria In Solid Tumors (RECIST)
时间窗: Baseline up to 5 years
次要结局
- Percentage of Participants by Prognostic Factors(Baseline up to 5 years)
- Percentage of Participants by Carcinoembryonic Antigen Tumor Marker(Baseline)
- Percentage of Participants by Cancer Antigen 19-9 Tumor Marker(Baseline)
- Percentage of Participants by Eastern Cooperative Oncology Group (ECOG) Performance Status(Baseline)
- Percentage of Participants by Comorbidity Index as per Carlson Method(Baseline)
- Percentage of Participants by RAS Mutation Status(Baseline)
- Percentage of Participants by Cancer Metastasation Status(Baseline)
- Percentage of Participants According to Previous Treatment Regimen of Bevacizumab(Baseline)
- Progression-Free Survival as Assessed by RECIST (Overall)(Baseline up to 5 years)
- Overall Survival in Daily Routine Practice(Baseline up to 5 years)
- Overall Survival in Defined Participant Subgroups in Daily Routine Practice(Baseline up to 5 years)
- Percentage of Participants Showing Overall Response in Daily Routine Practice as Assessed by RECIST(Baseline up to 5 years)
- Number of Treatment Application Schemes of Bevacizumab Daily Routine Practice(Baseline up to 5 years)
- Number of Participants With Adverse Event(Baseline up to 5 years)
- Number of Participants With Reason for Bevacizumab Treatment Modifications and Discontinuation in Defined Participant Subgroups(Baseline up to 5 years)
- Total Cumulative Therapy Dose of Bevacizumab(Baseline up to 5 years)
- Percentage of Participants With Treatment Success(Baseline up to 5 years)
- Percentage of Participants With Resection(Baseline up to 5 years)
- Number of Physicians Satisfied With Treatment(Baseline up to 5 years)
- Percentage of Participants Without Resection by Reason(Baseline up to 5 years)
- Percentage of Participants With Follow-Up therapy(Baseline up to 5 years)
- Percentage of Participants in Defined Participant Subgroups Showing Overall Response in Daily Routine Practice as Assessed by RECIST(Baseline up to 5 years)