Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer
Recruiting · NCT05179889 · Interventional (participants receive a specific treatment) · Lead sponsor: Chungnam National University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
mFOLFIRINOXmFOLFOX 6
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
Who can take part
Age range
20 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Chungnam National University Hospital - Daejeon, South Korea