RecruitingPhase 2Phase 3NCT05179889

Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer

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

Sponsor

Chungnam National University Hospital

Enrollment

308 participants

Start Date

Jul 6, 2021

Study Type

INTERVENTIONAL

Conditions

Colon Cancer Stage III

Summary

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

Eligibility

Min Age: 20 YearsMax Age: 75 Years

Inclusion Criteria14

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 Criteria10

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

Interventions

DRUGmFOLFIRINOX

Irinotecan 150 mg/m2 IV day 1, oxaliplatin 85 mg/m2 IV day 1, Leucovorin 400 (or levoleucovorin 200) mg/m2 IV day 1, 5-FU 1200 mg/m2/d IV x 2 days (total 2400 mg/m2 over 48 hours) continuous infusion\] 12 cycles per 2 weeks mFOLFOX 6 \[Oxaliplatin 85 mg/m2 IV day 1, Leucovorin 400 (or levoleucovorin 200) mg/m2 IV day 1, 5-FU 400 mg/m2 IV bolus day 1, 5-FU 1200 mg/m2/d IV x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion, 12 cycles per 2 week

DRUGmFOLFOX 6

Oxaliplatin 85 mg/m2 IV day 1, Leucovorin 400 (or levoleucovorin 200) mg/m2 IV day 1, 5-FU 400 mg/m2 IV bolus day 1, 5-FU 1200 mg/m2/d IV x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion, 12 cycles per 2 weeks