NCT01555762已完成不适用
Non Interventional Study Evaluating Efficacy and Safety in a Cohort of Elderly Patients of First Line Therapy With Avastin ® Regimen for Metastatic Colorectal Cancer.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 402
- 试验地点
- 165
- 主要终点
- Progression-Free Survival
研究概览
简要总结
This multicenter, prospective, observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in first-line therapy in elderly patients with metastatic colorectal cancer. Data will be collected from eligible patients for24 months.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, >/= 75 years of age
- •Metastatic colorectal cancer
- •Initiating Avastin first-line therapy in combination with chemotherapy
排除标准
- •Previous Avastin therapy
- •Patient participating in a clinical study evaluating a cytotoxic anti-cancer therapy and/or an investigational new drug
结局指标
主要结局
Progression-Free Survival
时间窗: From the time of first dose of study treatment to the time of disease progression or death from any cause (Up to 53 months)
Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Percentage of Participants With Balducci Score(Baseline, Month 6, 12, 24)
- Percentage of Participants With Bevacizumab Administration(Up to 36 months)
- Percentage of Participants With Adverse Events (AEs)(Up to 53 months)
- Percentage of Participants With Activities of Daily Living (ADL)(Baseline, Month 6, 12, 24)
- Overall Survival(From the time of first dose of study treatment to the time of death from any cause (Up to 53 months))
- Lawton Instrumental Activities of Daily Living Score (IADL)(Baseline, Month 6, 12, 24)
研究者
研究点 (165)
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