REBECCA: A Cohort Study of Regorafenib in the Real-life Setting in Patients Previously Treated for Metastatic Colorectal Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 704
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This is a largest cohort study aimed to estimate the overall survival of patients been treated with regorafenib for metastatic colorectal cancer (mCRC) within the frame of a french compassionate program.
详细描述
Regorafenib (REG) is a multi-kinase inhibitor with survival benefits in patients with pretreated mCRC, as demonstrated in the phase III CORRECT study. As a result, REG has been made available for medical practice use in the US, and in the Europe. However, prescribing conditions in the real-life setting are known to be less stringent than selection criteria in clinical trials. The REgorafeniB in mEtastatic Colorectal cancer: a French Compassionate progrAm (REBECCA) is an ambispective cohort study designed to elucidate safety and effectiveness outcomes associated with REG as used in clinical practice for mCRC who have been previously treated with, or are not considered candidates for, available therapies.
Patients were identified from the database of the French ATU (Temporary Authorization for Use), approved by the French Health Authorities to provide early access to innovative, not yet approved medicinal products such as REG.
Baseline patient and tumor characteristics, REG dosing and dose-intensity, REG-related adverse events, pre- and post REG treatments, predictors of events, and effectiveness data (PFS, OS) were collected from patients who agreed, and whom physicians accepted to collaborate on the REBECCA cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patient ≥ 18 years old
- •With a colorectal cancer metastatic histologically proven
- •Have met the criteria defined in the monograph ATU (Temporary Authorization for Use) validated by French Health Authorities and for which the request for access to treatment has been validated, that is in patients with mCRC as used in clinical practice for mCRC who have been previously treated with, or are not considered candidates for, available therapies.
- •Patients who received at least one dose on REG
排除标准
- •Opposed to the study
- •Patient does not meet the inclusion criteria
- •Patient deprived of liberty or under guardianship
结局指标
主要结局
Overall survival (OS)
时间窗: at death or at the end of study
median time between the date of the first administration REG and the date of the death
次要结局
- Patients and tumor baseline characteristics(at the end of treatment)
- Time under REG treatment(at the end of treatment)
- Compliance(at the end of study)
- Safety of REG(at the end of treatment)
- Potential predictive factors(at the end of study)
- Progression-free survival (PFS)(at the end of study)