Stivarga Real Life Evidence in Hungary

NCT02656524 | Completed

• 1 other identifier: 18686
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms

Keywords

Metastatic colorectal cancer

Outcome Measures

Primary Outcomes (4)

• 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

  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)

  Retrospective analysis of 2 year period

• 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

Secondary Outcomes (1)

• Resource utilization per patient

  Retrospective analysis of 2 year period

Other Outcomes (4)

• Time to treatment failure (TTF)

  Retrospective analysis of 2 year period

• Time to progression (TTP)

  Retrospective analysis of 2 year period

• Characteristics of patients with better response

  Retropsective analysis of 2 year period

Study Arms (1)

Cohort1/Regorafenib

All patients with at least 1 treatment with regorafenib

Drug: Regorafenib (Stivarga, BAY73-4506)

Interventions

Regorafenib (Stivarga, BAY73-4506) DRUG

Product is used in accordance with SmPC

Cohort1/Regorafenib

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be all patients who met the criteria within the SmPC. 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.

You may qualify if:

• 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).

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Budapest, Hungary

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: January 15, 2016
• Study Start: July 1, 2016
• Primary Completion: February 15, 2017
• Study Completion: February 15, 2017
• Last Updated: February 12, 2018

Record last verified: 2018-02

Locations

HU (1)