NCT02967289

IRinotecan and Oxaliplatin for Colon Cancer in Adjuvant Setting

A Phase III, Randomised, International Trial Comparing mFOLFIRINOX Triplet Chemotherapy to mFOLFOX for High-risk Stage III Colon Cancer in Adjuvant Setting

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 792 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The trial is a phase III, multicenter, open-labeled randomized trial comparing the association of 5-fluorouracil (5-FU), folinic acid, irinotecan, and oxaliplatin (mFOLFIRINOX) versus oxaliplatin, folinic acid, and 5-FU (mFOLFOX 6) chemotherapy protocols in patients with high-risk stage III colon cancer in the adjuvant setting.

Detailed description

After inclusion and non-inclusion criteria have been fulfilled and the patient consent has been obtained, the patient will be included and randomized in the trial. The maximum delay allowed between the signature of the consent form by the patient and the randomization in the study is 28 days. The randomization procedure using minimization method will allocate the treatments mFOLFIRINOX or mFOLFOX 6 with a 1:1 ratio, and will be stratified by the following criteria: * Perforation or urgent surgery versus no perforation and no urgent surgery. * T1-T3N2 vs T4aN1 versus T4bN1 versus T4N2. * Right colon (right of splenic flexure) vs left colon. * Country (France vs Canada vs Italy). Patient eligible and who have signed the informed consent will be randomized in one of the two treatments arms and will receive every 14 days their treatment for a duration of 12 cycles. Arm A: mFOLFIRINOX Arm B: mFOLFOX 6

Conditions

• Colon Cancer (High-risk Stage III: pT4N1 or pT1 to 4 N2)

Interventions

Type	Name	Description
DRUG	Irinotecan	every 14 days, 12 cycles, 24 weeks, new cycle beginning on day 15: irinotecan (Campto®) 180 mg/m² on D1, IV infusion over 90 minutes to begin 30 min after folinic acid infusion is started
DRUG	Folfox Protocol	every 14 days, 12 cycles, 24 weeks, new cycle beginning on day 15: oxaliplatin (Eloxatin®) 85 mg/m² on D1, IV infusion over 2 hours, followed by folinic acid 400 mg/m² (racemic mixture) (or 200 mg/m² if L-folinic acid) IV infusion over 2 hours 5-FU 2400 mg/m²/h IV continuous infusion over 46 hours starting at the end of folinic acid infusion

Timeline

• Start date: 2017-03-27
• Primary completion: 2025-06-15
• Completion: 2025-07-15
• First posted: 2016-11-18
• Last updated: 2025-11-17

Locations

17 sites across 2 countries: Canada, France