P-277 A prospective, observational trial to assess the safety and efficacy of regorafenib in patients with metastatic colorectal cancer (mCRC) in routine clinical practice (CORRELATE)

Abstract

Introduction: Two randomized, double‐blind, phase 3 trials have shown that the oral multikinase inhibitor regorafenib significantly improves overall survival vs placebo in patients with mCRC that has progressed on available treatments (Grothey A, Van Cutsem E, et al. Lancet 2013;381:303‐312; Li J, et al. Lancet Oncol 2015;16:619‐629). The aim of CORRELATE is to characterize the safety and efficacy of regorafenib for the treatment of mCRC in an unselected real‐world patient population treated in routine clinical practice. Methods: This prospective, observational, multicenter trial (ClinicalTrials.gov NCT02042144) is being conducted in routine clinical practice settings in more than 25 countries in Europe, Latin America, and the Asia‐Pacific region. The trial will recruit approximately 1,000 patients with mCRC previously treated with other approved therapies and for whom the decision to treat with regorafenib has been made by the treating physician according to local health authority approved label. Dose interruptions and reductions will be permitted for the management of adverse events. The primary endpoint is the incidence of treatment‐emergent adverse events (NCICTCAE v4.03). Secondary endpoints are overall survival, progression‐free survival, disease control rate, health‐related quality of life (assessed using the EQ‐5D questionnaire), and healthcare resource use. Data sources will include medical records, routine measurements, and patient‐reported outcomes. All patients receiving at least 1 dose of regorafenib will be included in the overall analysis. One planned interim analysis will occur after 500 patients have been observed for at least 3 months. The final analysis will be performed when all patients have been followed for 6 months from the time they discontinue regorafenib (unless they withdrew from the trial early because of death, consent withdrawal, or patient/investigator decision to stop). Recruitment is ongoing, with 404 patients enrolled as of February 2016. The estimated primary completion date is September 2017.