LCCC 1029/ICORG 12-07
Research type
Research Study
Full title
A Multi-Center, Randomized, Placebo-Controlled Phase II Study of Regorafenib in Combination With FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) Versus Placebo With FOLFIRI as Second-Line Therapy in Patients with Metastatic Colorectal Cancer.
IRAS ID
139348
Contact name
David Cunningham
Contact email
Sponsor organisation
ICORG (the all-Ireland Cooperative Oncology Research Group)
Eudract number
2012-000709-59
Clinicaltrials.gov Identifier
Research summary
The study will be conducted in patients with colorectal cancer which has spread into other parts of the body (i.e. metastatic disease)whose cancer has progressed during or shortly after their 1st oxaliplatin containing chemotherapy regimen.
This study will investigate if regorafenib when given in combination with standard
chemotherapy (FOLFIRI) will help slow the progression of metastatic colorectal cancer as compared to a non-active treatment (placebo)given in combination with standard chemotherapy (FOLFIRI).
Patients will be allocated randomly to one of two treatment groups. Patients in Group A will receive regorafenib in combination with standard chemotherapy (FOLFIRI) and patients in Group B will receive a non-active treatment (placebo)given in combination with standard chemotherapy (FOLFIRI). Once randomised to one of the two groups, patients will take the trial treatments until they no longer
benefit from them (ie. their disease progresses) or they experience side effects which requires them to withdraw from the study.
Patients in both groups will visit hospital for administration of drugs (FOLFIRI) intravenously (through a vein) every 2 weeks (Day 1 and 15 of each 28 day cycle). Patients in both groups will also take regorafenib (Group A) or placebo (Group B) tablets on days 4-10 and days 18-24 of each 28 day cycle.REC name
London - Surrey Borders Research Ethics Committee
REC reference
14/LO/0754
Date of REC Opinion
21 Oct 2014
REC opinion
Further Information Favourable Opinion