Overview
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
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
Eligibility
Inclusion Criteria:
- Age of 20-70 years with an ECOG ≤ 2
- Age of 71-75 years with an ECOG = 0
- Pathologically confirmed high-risk stage III colon adenocarcinoma (pT4N1 or pTanyN2)
- Curative radical resection (successful R0 resection) within 60 days before randomization
- Adequate organ functions
- ANC ≥ 2×106 cells/mL
- Hemoglobin ≥ 9.0 g/dL
- Platelets ≥ 100×106 cells/mL
- Alanine aminotransferase/aspartate aminotransferase ≤2.5 × times the upper limit of normal (ULN)
- Serum total bilirubin ≤ 1.5 ULN
- Alkaline phosphatase ≤ 2.5 × ULN
- Serum creatinine ≤1.5 × ULN or creatinine clearance \> 50 mL/min (Cockcroft-Gault formula)
- Able to understand and willing to sign and date written voluntary informed consent form
- Life expectancy ≥ 5 years
Exclusion Criteria:
- Distant metastasis
- Middle or lower rectal cancer of need for radiotherapy
- Postoperative complication of 3 or more grades of Clavien-Dindo classification
- Underlying disease or postoperative condition which is contraindication for chemotherapy
- Known hypersensitivity reaction to any study treatment component
- Familial adenomatosis polyposis or hereditary non-polyposis colorectal cancer
- Inflammatory bowel disease
- Previous other malignancy which cannot be curatively treated
- Pregnancy or breast feeding
- Any other situation would exclude the patient from study based on the investigator's opinion
