Trial Condition(s):
Colorectal Neoplasms
Stivarga real life evidence in Hungary
Bayer Identifier:
18686
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Budapest, Hungary | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Trial Design
Effectiveness of Stivarga (regorafenib) for Patients with Metastatic Colorectal Cancer in the Hungarian real World Setting
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Length of treatment for each treatment episodeThe 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 episodeTimeframe: Retrospective analysis of 2 year period
- Progression Free Survival (PFS)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)Timeframe: Retrospective analysis of 2 year period
- Overall Survival (OS)Timeframe: Retrospective analysis of 2 year period
- Number of participants with treatment emergent adverse events as a measure of safety and tolerabilityTimeframe: Retrospective analysis of 2 year period
Secondary Outcome
- Resource utilization per patientCosts per patient for the reimbursed healthcare service e.g. inpatient care, outpatient visit, emergency departement visit, pharmaceutical dispensingTimeframe: Retrospective analysis of 2 year period
Additional Information
Copyright © Bayer
Powered by
