Compares two chemotherapy regimens after surgery for high-risk colon cancer
Compares two chemotherapy combinations in adults with high-risk colon cancer after surgery.
Plain-language title generated from the registry record
Registry title: Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer
Key facts
- Where
- Daejeon, South KoreaSee the site
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 75 years old?
Source: NCT05179889, who can take part
Where in South Korea
- Chungnam National University HospitalDaejeon, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chungnam National University Hospital
- Trial code
- NCT05179889
- Record updated
- 19 March 2026
- Original description
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 cancerRead full original descriptionShow less
mFOLFIRINOX Versus mFOLFOX 6 as Adjuvant Treatment for High Risk Stage III (pT4N1/2 or pTanyN2) Colon Cancer: Multicenter, Open Labeled, Randomized, Phase II 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
Inclusion: 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: Middle or lower rectal cancer of need for radiotherapy; 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; Distant metastasis; Postoperative complication of 3 or more grades of Clavien-Dindo classification; Pregnancy or breast feeding; Any other situation would exclude the patient from study based on the investigator's opinion.