Phase 3 Trial of Regorafenib as Adjuvant Therapy in Colon Cancer

Title: A Phase III Randomized Placebo-Controlled Study Evaluating Regorafenib Following Completion of Standard Chemotherapy for Patients With Stage III Colon Cancer¹

Principal Investigator: Norman Wolmark, MD, NSABP Foundation

Description: For this randomized, double-blind phase 3 study, researchers are investigating the efficacy of regorafenib in prolonging disease-free survival (DFS) among patients with stage IIIB or IIIC colon cancer compared with placebo.

Eligible patients must have completed at least 4 months of a standard adjuvant therapy, including 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX), capecitabine and oxaliplatin (CapeOx), or others.

Patients will receive placebo or regorafenib 120 mg once daily for 3 weeks of a 4 week cycle for 2 years.

The primary endpoint is 10-year DFS. Secondary outcomes include overall survival, assessments of toxicity, 2-year compliance, correlative science (biomarkers, pharmacodynamics, pharmacokinetics), and comparative evaluation of treatment-related adverse events among patients receiving regorafenib and placebo.

The estimated enrollment is 1118 patients.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/study/NCT02664077.

Status: This study is open and recruiting patients as of September 25, 2017.

This study is sponsored by NSABP Foundation, Inc in collaboration with Bayer.

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