NCT02542436撤回不适用
An Observational Study to Investigate the Real World Effectiveness of Avastin (Bevacizumab) in the Treatment of Metastatic Colorectal Cancer in the UK
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This study will focus on participants in the United Kingdom (UK) to collect local data on the effectiveness and safety of bevacizumab (Avastin) in the treatment of metastatic colorectal cancer in normal clinical use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Have been diagnosed with metastatic colorectal cancer (mCRC)
- •Have a Performance Status (PS) of 0-2, according to the Eastern Cooperative Oncology Group (ECOG) criteria at initiation of bevacizumab treatment
- •Be chemotherapy-naive at diagnosis of mCRC or have relapsed more than 12 months after receiving adjuvant chemotherapy for early stage colorectal cancer
- •Have received standard fluoropyrimidine-based chemotherapy for first-line treatment of mCRC with or without bevacizumab
- •Have sufficient medical records available for assessment of eligibility at the Christie Hospital National Health Service (NHS) Trust, Manchester, United Kingdom
- •For Cohort 1 (post CDF funding availability): patients between 2010-2013 who received bevacizumab with first-line chemotherapy
- •For Cohort 2 (pre Cancer Drugs Fund [CDF] funding availability): patients propensity matched to cohort 1 between 2005-2008 who did not receive bevacizumab with first-line chemotherapy
排除标准
- •Subjects with metastatic colorectal cancer, who have received bevacizumab via a clinical trial
- •Subjects with metastatic colorectal cancer, whose medical records are not complete enough to confirm eligibility for the study
结局指标
主要结局
Overall Survival (OS)
时间窗: From date of metastatic colorectal cancer diagnosis to date of death up to 3 years
次要结局
- Progression Free Survival (PFS)(From date of metastatic colorectal cancer diagnosis to end of study up to 3 years)
- Percentage of Participants with Adverse Events of Special Interest(From date of metastatic colorectal cancer diagnosis to end of study up to 3 years)
- Response Rate (RR)(From date of metastatic colorectal cancer diagnosis to end of study up to 3 years)
研究者
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