Trial Condition(s):

Colorectal Neoplasms

Stivarga real life evidence in Hungary

Bayer Identifier:

18686

ClinicalTrials.gov Identifier:

NCT02656524

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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).
Exclusion Criteria
- Not applicable

Trial Summary

Enrollment Goal
400
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Budapest, Hungary

Status
Completed
 

Trial Design