Actively Recruiting
Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer
Led by Chungnam National University Hospital · Updated on 2026-03-19
308
Participants Needed
1
Research Sites
505 weeks
Total Duration
On this page
Sponsors
C
Chungnam National University Hospital
Lead Sponsor
B
Boryung Pharmaceutical Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20-70 years with an ECOG performance status of 0 to 2
- Age 71-75 years with an ECOG performance status of 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 function including:
- Absolute neutrophil count of at least 2 x 10^6 cells/mL
- Hemoglobin level of at least 9.0 g/dL
- Platelet count of at least 100 x 10^6 cells/mL
- Liver enzymes no more than 2.5 times the upper limit of normal
- Serum total bilirubin no greater than 1.5 times the upper limit of normal
- Alkaline phosphatase no greater than 2.5 times the upper limit of normal
- Serum creatinine no greater than 1.5 times the upper limit of normal or creatinine clearance over 50 mL/min
- Able to understand and willing to sign a written informed consent form
- Life expectancy of at least 5 years
You will not qualify if you...
- Presence of distant metastasis
- Middle or lower rectal cancer requiring radiotherapy
- Postoperative complications classified as grade 3 or higher by Clavien-Dindo
- Underlying diseases or postoperative conditions that contraindicate chemotherapy
- Known hypersensitivity to any component of the study treatments
- Diagnosis of familial adenomatosis polyposis or hereditary non-polyposis colorectal cancer
- History of inflammatory bowel disease
- Previous malignancy that cannot be cured
- Pregnancy or breastfeeding
- Any other condition that, in the investigator's opinion, excludes the patient from the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chungnam National University Hospital
Daejeon, South Korea, 34112
Actively Recruiting
Research Team
K
Kyung Ha Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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