Correlate - Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,034
- 主要终点
- Incidence of all treatment-emergent adverse events (TEAE) - Patients will be monitored for TEAE using the NCI-CTCAE Version 4.3
研究概览
简要总结
This study is a prospective observational cohort study. The study will be conducted in routine clinical practice settings. It is planned to enroll 1000 patients with metastatic Colorectal Cancer (mCRC) who have been previously treated with other approved treatments for metastatic disease and for whom a decision has been made by the physician to treat with regorafenib according to local health authority approved label. It is the aim of this observational cohort study to further characterize safety and effectiveness of regorafenib in routine clinical practice setting. Healthcare resource utilization in the routine provision of care is becoming increasingly important from a health economics and outcomes research perspective. Therefore, another aim of this observational cohort study is to capture healthcare resource associated with the management of treatment emergent adverse events in the real world setting. The primary objective of this study is to further characterize safety of regorafenib use in routine clinical practice settings. The secondary objective of this study is to assess the effectiveness of regorafenib in routine clinical practice settings as measured by Overall Survival (OS), Progression Free Survival (PFS) and Disease control rate (DCR). Health Related Quality of Life (HRQoL) Data will be collected in applicable countries.
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
- •Patients diagnosed with mCRC who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator's routine treatment practice to prescribe regorafenib.
排除标准
- •Patients participating in an investigational program with interventions outside of routine clinical practice
研究组 & 干预措施
Group 1
干预措施: Stivarga (Regorafenib, BAY73-4506) (Drug)
结局指标
主要结局
Incidence of all treatment-emergent adverse events (TEAE) - Patients will be monitored for TEAE using the NCI-CTCAE Version 4.3
时间窗: Up to 42 months
次要结局
- Progression free survival (PFS) is defined as the time interval measured from the day of start with regorafenib treatment to (radiological or clinical) progression or death, whichever comes first.(Up to 42 months)
- Quality of Life - HRQoL using PRO questionnaire EQ-5D (8) in applicable countries(Up to 42 months)
- Overall Survival (OS), OS is defined as the time interval from the start of regorafenib therapy to death, due to any cause.(Up to 42 months)
- Disease control rate (DCR) - DCR is defined as percentage of patients, whose best response was not progressive disease (i.e. CR, PR or SD). Stable disease must be at least 6 weeks in duration.(Up to 42 months)
- Healthcare resource utilization(Up to 42 months)