Initial Safety Results From A Randomized, Phase Ii Study Of High-Risk Colorectal Cancer Patients (Stage Iiic) Treated With Either Regorafenib Or Standard Of Care (No Treatment) After Adjuvant Folfox.

TPS779 Background: Standard adjuvant treatment for colorectal cancer (CRC) is usually a fluoropyrimidine or FOLFOX. However the relapse rate for stage IIIC patients is high with a median 5 year survival of only 28%. The multi-kinase inhibitor regorafenib has been shown to significantly improve progression-free and overall survival (PFS; OS) compared with placebo as 3rd-line or later therapy for patients with metastatic CRC. Thus it is of interest to explore whether adding regorafenib to standard adjuvant therapy may be able to reduce the high relapse rates in patients with stage IIIC CRC. In addition, texture analysis (spatial variations in pixel intensity) of computed tomography (CT) scans may be a useful prognostic tool for determining risk of recurrence. Methods: The current study is designed to compare the efficacy and safety of adding 6 cycles of regorafenib versus standard of care (no additional systemic therapy) following 6 months of adjuvant FOLFOX in patients with high risk (stage IIIC) CRC. The ...