Regorafenib as adjuvant therapy for resected liver metastases
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled Phase-III Study of Adjuvant Regorafenib Versus Placebo for Patients with Stage IV Colorectal Cancer After Curative Treatment of Liver Metastases
IRAS ID
140311
Contact name
David Cunningham
Contact email
Sponsor organisation
Bayer HealthCare AG
Eudract number
2012-004369-42
Clinicaltrials.gov Identifier
Research summary
This is a randomised phase III study. The purpose of this study is to asses if regorafenib is effective at reducing the risk of colorectal cancer returning following complete resection of metastatic liver disease. Regorafenib works by stopping or slowing down the growth of tumours and may prevent cancer from spreading to other parts of the body.
The study is divided into different phases: screening, randomization, treatment, safety follow-up, active follow-up, and survival follow-up. The treatment phase will be a maximum of 2 years in duration, but could be less if the cancer returns. Patients who are free of their cancer at the end of the 2 year treatment phase will enter the active follow-up phase of the study and then the survival follow-up phase.
A total of approximately 750 patients will participate in this study at multiple locations internationally.
REC name
North West - Haydock Research Ethics Committee
REC reference
13/NW/0705
Date of REC Opinion
21 Nov 2013
REC opinion
Further Information Favourable Opinion