Drug Use Investigation of Regorafenib/ STIVARGA for Unresectable, Metastatic or Recurrent Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,301
- 主要终点
- Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib
研究概览
简要总结
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Regorafenib for colorectal cancer.
The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice.
A total of 1,250 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •who are determined to start Regorafenib/ STIVARGA treatment
排除标准
- •Patients who have previously received Regorafenib/ STIVARGA
研究组 & 干预措施
Group 1
干预措施: Regorafenib (Stivarga, BAY73-4506) (Drug)
结局指标
主要结局
Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib
时间窗: Up to 6 months
Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.
时间窗: up to 6 months
次要结局
- Overall survival (OS)(Up to 12 months)
- Time to Treatment failure in subpopulations(Up to 12 months)
- Number of pateints with ADRs in subpopulations(Up to 6 months)
- Number of patients with SAEs in supopulations(Up to 6 months)
- Overall survival in subpopulations(Up to 12 months)
- Time to treatment failure (TTF)(Up to 12 months)
- Tumor response assessed by RECIST or physicians own evaluation(Up to 6 months)