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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Fluorouracil; Leucovorin; Oxaliplatin

Criteria

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