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

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.

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.

Inclusion Criteria:

• Curatively resected, histologically confirmed colon adenocarcinoma
• AJCC/UICC high-risk stage II, stage III colon cancer
• Age over 18 years old
• Performance status (ECOG scale): 0-1
• Adequate major organ functions
• Patients should sign a written informed consent before study entry

Exclusion Criteria:

• Colon cancer other than adenocarcinoma
• Rectal cancer
• R1 or R2 resections
• Other malignancies within the last 5 years
• Symptomatic peripheral sensory neuropathy
• Presence of other serious disease
• Lactating or pregnant women
• Fertile women