A Cohort Study of Patients With Metastatic Colorectal Cancer Treated With Avastin® as First-line Therapy for Liver Metastases Considered as Potentially Resectable
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 124
- 主要终点
- Percentage of Participants Without Detectable Metastatic Disease After Secondary Resection Post Surgery
研究概览
简要总结
This observational study will evaluate the efficacy and safety of bevacizumab as first-line treatment in participants with colorectal cancer and potentially resectable liver metastases.
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 colorectal cancer with exclusively hepatic or hepatic and pulmonary metastases
- •First-line treatment with bevacizumab for potentially resectable metastatic disease
排除标准
- •Outright resectable disease
- •Clearly inoperable disease
- •Participation in a clinical trial evaluating a cytotoxic anticancer treatment and/or an innovative therapy
研究组 & 干预措施
Bevacizumab
Participants with metastatic colorectal cancer (mCRC) with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases will be observed.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Percentage of Participants Without Detectable Metastatic Disease After Secondary Resection Post Surgery
时间窗: Baseline up to 36 months
Secondary resection involves removal of all detectable metastases at surgery including participants with missing metastases left in place. Percentage of participants without detectable metastatic disease after secondary resection removing all detectable metastases at surgery (including participants with disappeared metastases left in place \[missing metastases\]) was reported. Metastases was detected using computed tomography (CT) scan or magnetic resonance imaging (MRI).
Percentage of Participants Without Detectable Metastatic Disease After a Complete Response Without Surgery
时间窗: Baseline up to 36 months
The percentage of participants with no detectable metastatic disease after a complete response without surgery (missing metastasis) was reported.
次要结局
- Relapse-free Survival (RFS)(Baseline until disease progression or death, whichever occurred first, assessed up to 36 months)
- Percentage of Participants Who Died(Baseline until death; assessed up to 36 months)
- Overall Survival (OS)(Baseline until death, assessed up to 36 months)
- Percentage of Participants With Histologically Viable Tumor Cells With Resected Non Detectable Hepatic and Pulmonary Metastases Post Surgery(Baseline up to 36 months)
- Number of Cumulated Cycles of First Line Bevacizumab at Day 0(Day 0)
- Percentage of Participants With Different Doses of First Line Bevacizumab at Day 0(Day 0)
- Total Duration of First Line Bevacizumab Treatment at Day 0(Day 0)
- Percentage of Participants With Unresectability Criteria(Day 0)
- Percentage of Participants With at Least One Disease and Comorbidity at Day 0(Day 0)
- Percentage of Participants With Different Previous Therapies at Day 0(Day 0)
- Mean Number of Cumulated Cycles of Bevacizumab Over the Study Period(Baseline up to 36 months)
- Percentage of Participants Who Received at Least One Chemotherapy Over the Study Period(Baseline up to 36 months)
- Percentage of Participants With at Least One Comorbidity Post Bevacizumab Treatment(Baseline up to 36 months)
- Percentage of Participants With Disease Progression or Death(Baseline until disease progression or death, whichever occurred first, assessed up to 36 months)
- Progression-free Survival (PFS)(Baseline until disease progression or death, whichever occurred first, assessed up to 36 months)
- Percentage of Participants With Disease Relapse(Baseline until disease progression or death, whichever occurred first, assessed up to 36 months)