NCT05179889

Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer

mFOLFIRINOX Versus mFOLFOX 6 as Adjuvant Treatment for High Risk Stage III (pT4N1/2 or pTanyN2) Colon Cancer: Multicenter, Open Labeled, Randomized, Phase II Study

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 308 (estimated)
• Sponsor: Chungnam National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, open labeled randomized, phase II trial comparing mFOLFIRINOX and mFOLFOX6 as adjuvant treatment for high risk stage III (pT4N1/2 or pTanyN2) colon cancer

Detailed description

After inclusion and exclusion criteria have been fulfilled and the patient consent has been obtained, the patient will be included and randomized to mFOLFIRINOX or mFOLFOX 6 with a 1:1 ratio. Arm A: mFOLFIRINOX Arm B: mFOLFOX

Conditions

• Colon Cancer Stage III

Interventions

Type	Name	Description
DRUG	mFOLFIRINOX	Irinotecan 150 mg/m2 IV day 1, oxaliplatin 85 mg/m2 IV day 1, Leucovorin 400 (or levoleucovorin 200) mg/m2 IV day 1, 5-FU 1200 mg/m2/d IV x 2 days (total 2400 mg/m2 over 48 hours) continuous infusion\] 12 cycles per 2 weeks mFOLFOX 6 \[Oxaliplatin 85 mg/m2 IV day 1, Leucovorin 400 (or levoleucovorin 200) mg/m2 IV day 1, 5-FU 400 mg/m2 IV bolus day 1, 5-FU 1200 mg/m2/d IV x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion, 12 cycles per 2 week
DRUG	mFOLFOX 6	Oxaliplatin 85 mg/m2 IV day 1, Leucovorin 400 (or levoleucovorin 200) mg/m2 IV day 1, 5-FU 400 mg/m2 IV bolus day 1, 5-FU 1200 mg/m2/d IV x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion, 12 cycles per 2 weeks

Timeline

• Start date: 2021-07-06
• Primary completion: 2028-07-05
• Completion: 2031-03-15
• First posted: 2022-01-06
• Last updated: 2026-03-19

Locations

1 site across 1 country: South Korea