IRinotecan and Oxaliplatin for Colon Cancer in Adjuvant Setting

Official Title

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

Summary:

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

Trial Description

Primary Outcome:

• Disease Free Survival (DFS)

Secondary Outcome:

• Disease Free Survival
• Overall Survival
• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

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

View this trial on ClinicalTrials.gov