Status: Closed
Activation Date: 2017MAY02
Closing Date: 2023JUN14
Phase: III
Description: A Phase III, Randomised, International Trial Comparing mFOLFIRINOX Triplet Chemotherapy to mFOLFOX for high Risk Stage III Colon Cancer in Adjuvant Setting
Eligibility: Inclusion: 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.
Objective: Primary Objective: 3 year Disease Free Survival (DFS) Secondary Objectives: 2 year DFS, Overall Survival, safety of study treatment
Participation: Open to member centres
Lay Description: The purpose of this study is to find out whether standard treatment with mFOLFOX (combination of 3 drugs: 5-fluorouricil, leucovorin, and oxaliplatin) or a different combination treatment called mFOLFIRINOX (combination of 4 drugs: 5-fluorouricil, leucovorin, irinotecan and oxaliplatin) is better at preventing high-risk stage III colon cancer that has been surgically removed from coming back. To do this, half of the patients in this study will get mFOLFOX and the other half will receive mFOLFIRINOX. You will know what treatment you will get and both treatments last approximately 6 months.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GASTRO-INTESTINAL | CO27 | 153 | 72 | 54 | 120 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| GASTRO-INTESTINAL | CO27 | 153 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| GASTRO-INTESTINAL | CO27 | 153 | 131 | 0 | 0 | 0 | 131 | 0 | 0 | 0 |