Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer

Chungnam National University Hospital

Status and phase: Invitation-only; Phase 3; Phase 2

Conditions: Colon Cancer Stage III

Treatments: Drug: mFOLFOX 6; Drug: mFOLFIRINOX

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05179889

2020-11-062

Details and patient eligibility

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

Full description

After inclusion and exclusion criteria have been fulfilled and the patient consent has been obtained, the patient will be included and randomized to mFOLFIRINOX or mFOLFOX 6 with a 1:1 ratio.

Arm A: mFOLFIRINOX Arm B: mFOLFOX

Enrollment: 308 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age of 20-70 years with an ECOG ≤ 2

2. Age of 71-75 years with an ECOG = 0

3. Pathologically confirmed high-risk stage III colon adenocarcinoma (pT4N1 or pTanyN2)

4. Curative radical resection (successful R0 resection) within 60 days before randomization

5. 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)

6. Able to understand and willing to sign and date written voluntary informed consent form

7. Life expectancy ≥ 5 years

Exclusion criteria

1. Distant metastasis
2. Middle or lower rectal cancer of need for radiotherapy
3. Postoperative complication of 3 or more grades of Clavien-Dindo classification
4. Underlying disease or postoperative condition which is contraindication for chemotherapy
5. Known hypersensitivity reaction to any study treatment component
6. Familial adenomatosis polyposis or hereditary non-polyposis colorectal cancer
7. Inflammatory bowel disease
8. Previous other malignancy which cannot be curatively treated
9. Pregnancy or breast feeding
10. Any other situation would exclude the patient from study based on the investigator's opinion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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308 participants in 2 patient groups

Arm A

Experimental group

Description:

mFOLFIRINOX

Treatment:

Drug: mFOLFIRINOX

Arm B

Active Comparator group

Description:

mFOLFOX 6

Treatment:

Drug: mFOLFOX 6