At a glance
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A Phase III Randomized Placebo-Controlled Study Evaluating Regorafenib Following Completion of Standard Chemotherapy for Patients With Stage III Colon Cancer
In Brief
A Phase 3 clinical trial evaluating Regorafenib and Placebo for Stage III (IIIB or IIIC) Colon Cancer. Terminated early, enrolled 34 participants across 51 sites.
Signals
Detailed Summary
This study is a randomized, double-blind, post-chemotherapy, adjuvant phase III clinical trial. The primary aim of this study is to determine the value of regorafenib in improving disease-free survival (DFS). Patients with Stage III (IIIB or IIIC) colon cancer as defined by the 7th Edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual are randomized 1:1 to placebo or the experimental agent regorafenib following completion of at least four months of standard adjuvant therapy (e.g., 5-fluorouracil, leucovorin, oxaliplatin (FOLFOX) , capecitabine, oxaliplatin (CapeOx), and other).
Study Details
Timeline
Interventions
3 tablets once a day by mouth for 21 consecutive days of 28 day cycle for 26 cycles
3 tablets once a day by mouth for 21 consecutive days of 28 day cycle for 26 cycles