drugset / Trial / NCT01092481

Study Investigating the Role of Oxaliplatin Duration in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Colon Cancer Therapy

NCT01092481 ↗

Phase 3 Unknown 1580 enrolled Samsung Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is designed to confirm that first 3 months of oxaliplatin in 6 months of modified FOLFOX-6 or CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer.

Timeline

Start
2010-01-26
Primary completion
2019-12
Completion
2019-12

Outcome

Met primary endpoint

paper with an HR of 0.953 (95% CI, 0.769 to 1.180; test for noninferiority, P = .0065) within the noninferiority margin. PMID 35772045 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxaliplatin Small molecule — —

Indications