Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer

Phase 2

• Conditions: Colon Cancer Stage III
• Interventions: Drug: mFOLFIRINOX; Drug: mFOLFOX 6

• Registration Number: NCT05179889
• Lead Sponsor: Chungnam National University Hospital

Brief 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

Detailed 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

Study Timeline

• Study Start: 2021-07-06
• Study First Submitted: 2021-12-17
• Study First Submitted QC: 2021-12-17
• Study First Posted: 2022-01-06
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30
• Primary Completion: 2025-03-15
• Study Completion: 2028-03-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 308

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	mFOLFIRINOX	mFOLFIRINOX
Arm B	mFOLFOX 6	mFOLFOX 6

Primary Outcome Measures

Name	Time	Method
Disease free survival (DFS)	3 years after the operation	the time from the date of operation to the date of the first recurrence or the death from any cause

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	3 years after the operation	the time from the date of operation to the date of the death from any cause
Incidence of treatment-related adverse events	3 years after the operation	Toxicity of all grade and more than grade 3 based on CTCAE version 5.0

Trial Locations

Locations (1)

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of