check_circleStudy Completed

Colorectal Neoplasms

Bayer Identifier:

18686

ClinicalTrials.gov Identifier:

NCT02656524

EudraCT Number:

Not Available

EU CT Number:

Not Available
Stivarga real life evidence in Hungary

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.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - 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).

  • - Not applicable

Trial summary

Enrollment Goal
400
Trial Dates
July 2016 - February 2017
Phase
N/A
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Budapest, Hungary

Primary Outcome

  • Length of treatment for each treatment episode
    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
    date_rangeTime Frame:
    Retrospective analysis of 2 year period
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    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    Retrospective analysis of 2 year period
    enhanced_encryption
    Safety Issue:
    No
  • Overall Survival (OS)
    date_rangeTime Frame:
    Retrospective analysis of 2 year period
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with treatment emergent adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Retrospective analysis of 2 year period
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Resource utilization per patient
    Costs per patient for the reimbursed healthcare service e.g. inpatient care, outpatient visit, emergency departement visit, pharmaceutical dispensing
    date_rangeTime Frame:
    Retrospective analysis of 2 year period
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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