Stage III Colon Cancer
Oxaliplatin has significant activity when combined with 5-FU-leucovorin in patients with metastatic colorectal cancer. In the 2,246 patients with resected stage II or stage III colon cancer in the MOSAIC study, the toxic effects and efficacy of FOLFOX4 were compared with the same 5-FU-leucovorin regimen without oxaliplatin administered for 6 months. The preliminary results of the study with 37 months of follow-up demonstrated a significant improvement in DFS at 3 years (77.8% vs. 72.9%, P = .01) in favor of FOLFOX4. When initially reported, there was no difference in OS.[Level of evidence: 1iiDii] Further follow-up at 6 years demonstrated that the OS for all patients (both stage II and stage III) entered into the study was not significantly different (OS = 78.5% vs. 76.0%; HR = 0.84; 95% CI, 0.71-1.00). On subset analysis, the 6-year OS in patients with stage III colon cancer was 72.9% in the patients receiving FOLFOX and 68.9% in the patients receiving 5-FU/LV (HR = 0.80; 95% CI, 0.65-0.97, P = .023).[Level of evidence: 1iiA] Patients treated with FOLFOX4 experienced more frequent toxic effects consisting mainly of neutropenia (41% >grade 3) and reversible peripheral sensorial neuropathy (12.4% >grade 3). FOLFOX has become the reference standard for the next generation of clinical trials for patients with stage III colon cancer.
Current Clinical Trials
Check for U.S. clinical trials from NCI's list of cancer clinical trials that are now accepting patients with stage III colon cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.
General information about clinical trials is also available from the NCI Web site.
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