A Randomized Phase III Study Investigating the Role of Oxaliplatin Duration (3 Months Versus 6 Months) in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Therapy for Patients With Stage II/III Colon Cancer
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. In addition, we would like to characterize pharmacogenomic profile associated with
toxicities and gene expression profiling to predict the recurrence of colon cancer as
parallel study.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
disease-free survival
3 years
Yes
Young Suk Park, M.D.,Ph.D.
Principal Investigator
Samsung Medical Center, Seoul, Korea
Korea: Food and Drug Administration
2009-11-008
NCT01092481
January 2010
December 2016
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