Canadian Cancer Trials Group Bulletins

Trial Management Group

Trial Activation: CO.27

CO.27 (IROCAS), A Phase III, Randomised, International Trial Comparing mFOLFIRINOX Triplet Chemotherapy to mFOLFOX for High-Risk Stage III Colon Cancer in Adjuvant Setting, has been centrally activated.

Adults with pathologically confirmed high-risk stage III colon adenocarcinoma, who have undergone curative R0 surgical resection within 42 days before randomization. No prior abdominal/pelvic radiotherapy and no prior chemotherapy; adequate hematologic function; adequate liver function (bilirubin > 1.5 xUNL), Creatinine clearance > 50 mL/min; patient information and signed informed consent. Exclusions: Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start; metastatic disease; IBS; known hypersensitivity to any of study drugs; clinically relevant CAD or history of MI in last year or uncontrolled arrhythmia; previous malignancy; known DPD deficiency or UGTA1A1 homozygous 7/7.

Primary Objective: 3-year Disease Free Survival (DFS)
Secondary Objectives: 2-year Disease Free Survival, Overall Survival, safety of study treatment

Participation: Open to member centres

For more information please contact: Maaike Hum, study coordinator