Recruiting
Phase 2 / Phase 3
Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer
About this study
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
- Condition
- Colon Cancer Stage III
- Tested
- mFOLFIRINOX, mFOLFOX 6
- Sponsor
- Chungnam National University Hospital
Who can join
- Age
- 20 to 75 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 17
- Minimum age: 20 years
- Maximum age: 75 years
- Study condition: Colon Cancer Stage III
- 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 10
- 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
Where
1 site, 1 recruiting
Chungnam National University Hospital
Daejeon, South Korea
Contact
-
Kyung Ha Lee
821042141415 lllllkh@cnuh.co.kr
Potential match only. Final eligibility is determined by the study team.