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临床试验/NCT02656524
NCT02656524已完成不适用

Effectiveness of Stivarga (Regorafenib) for Patients With Metastatic Colorectal Cancer in the Hungarian Real World Setting

Bayer0 个研究点目标入组 400 人开始时间: 2016年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Bayer
入组人数
400
主要终点
Overall Survival (OS)

研究概览

简要总结

The study aims to evaluate use of regorafenib in clinical practice in Hungary. The study should provide information about clinical characteristics of Hungarian regorafenib patients as well as information about safety and efficacy of regorafenib in Hungarian patients with metastatic colorectal cancer. This much needed data is required by the National Health Insurance Fund in order to accept regorafenib into the regular reimbursement system. This study is proposed to be based on patient data from the Hungarian National Health Insurance Fund's Database. Data to be analyzed includes patient demography and baseline tumor characteristics, overall survival, time to treatment failure, duration of treatment, average dose and dose modifications, and adverse events. Further, treatment costs will be estimated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Using the National Health Insurance Database, patients will be included in this retrospective data analysis if they had at least one dose of regorafenib treatment cycle (=28 days).

排除标准

  • Not applicable

研究组 & 干预措施

Cohort1/Regorafenib

All patients with at least 1 treatment with regorafenib

干预措施: Regorafenib (Stivarga, BAY73-4506) (Drug)

结局指标

主要结局

Overall Survival (OS)

时间窗: Retrospective analysis of 2 year period

Number of participants with treatment emergent adverse events as a measure of safety and tolerability

时间窗: Retrospective analysis of 2 year period

Length of treatment for each treatment episode

时间窗: Retrospective analysis of 2 year period

The length of each treatment episode will be calculated based on the duration between the initiation date of a treatment episode and the end date of the same treatment episode

Progression Free Survival (PFS)

时间窗: Retrospective analysis of 2 year period

PFS will be defined as days between start of the therapy and the date of the medical doctors opinion about progression (confirmed by radiology or clinical assessment)

次要结局

  • Resource utilization per patient(Retrospective analysis of 2 year period)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

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