Stivarga Real Life Evidence in Hungary

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Drug: Regorafenib (Stivarga, BAY73-4506)

• Registration Number: NCT02656524
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2016-01-13
• Study First Posted: 2016-01-15
• Study Start: 2016-07-01
• Primary Completion: 2017-02-15
• Study Completion: 2017-02-15
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-09
• Last Update Posted: 2018-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 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).

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Exclusion Criteria

• Not applicable

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort1/Regorafenib	Regorafenib (Stivarga, BAY73-4506)	All patients with at least 1 treatment with regorafenib

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Retrospective analysis of 2 year period
Number of participants with treatment emergent adverse events as a measure of safety and tolerability	Retrospective analysis of 2 year period
Length of treatment for each treatment episode	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)	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)

Secondary Outcome Measures

Name	Time	Method
Resource utilization per patient	Retrospective analysis of 2 year period	Costs per patient for the reimbursed healthcare service e.g. inpatient care, outpatient visit, emergency departement visit, pharmaceutical dispensing