mFOLFIRINOX Versus mFOLFOX 6 as Adjuvant Treatment for High Risk Stage III Colon Cancer Multicenter, Open Labeled, Randomized, Phase II Study

What this Trial Is About

Researchers are evaluating two chemotherapy treatments, mFOLFIRINOX and mFOLFOX 6, as adjuvant therapies for patients with high-risk stage III colon cancer. This phase II, multicenter, open-label randomized trial aims to compare these treatments in patients with specific tumor and lymph node characteristics (pT4N1/2 or pTanyN2) to understand their impact on disease-free survival over three years. Participants are randomly assigned in a 1:1 ratio to receive either mFOLFIRINOX or mFOLFOX 6. The mFOLFIRINOX regimen includes irinotecan, oxaliplatin, leucovorin, and 5-FU administered intravenously over 12 cycles every two weeks. The mFOLFOX 6 regimen consists of oxaliplatin, leucovorin, and 5-FU given intravenously over 12 cycles every two weeks. Both treatments involve continuous infusion of 5-FU over two days. During the study, participants will undergo regular assessments to monitor disease progression, survival, and treatment-related side effects. The primary outcome is disease-free survival measured three years after surgery. Secondary outcomes include overall survival and the incidence of adverse events over the same period. Participants must meet eligibility criteria and provide informed consent before enrollment, and the study will continue through follow-up until March 2031.

Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer