Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer

March 17, 2026 updated by: Kyung-ha Lee, Chungnam National University Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

308

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Daejeon, South Korea, 34112
        • Recruiting
        • Chungnam National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm B
mFOLFOX 6
Drug: 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 weeks
Experimental: Arm A
mFOLFIRINOX
Drug: mFOLFIRINOX

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival (DFS)
Time Frame: 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
3 years after the operation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chungnam National University Hospital

Collaborators

Boryung Pharmaceutical Co., Ltd

Investigators

  • Principal Investigator: Kyung Ha Lee, Chungnam National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2021

Primary Completion (Estimated)

July 5, 2028

Study Completion (Estimated)

March 15, 2031

Study Registration Dates

First Submitted

December 17, 2021

First Submitted That Met QC Criteria

December 17, 2021

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-11-062

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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