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Comparison of drug combinations containing irinotecan, oxaliplatin, fluorouracil and folinic acid for treatment of high-risk stage III colon cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with high-risk stage III colon cancer, a serious condition where cancer has spread to nearby lymph nodes. The study examines a combination treatment approach using four different medications given through intravenous infusion: oxaliplatin, folinic acid, irinotecan, and fluorouracil. This combination of drugs is known as chemotherapy and is given after surgery to remove the tumor.

The purpose of this research is to compare two different chemotherapy combinations - one called mFOLFIRINOX (which includes all four medications) and another called mFOLFOX (which includes all medications except irinotecan). Both treatments are given to patients after they have had surgery to remove their cancer, which is known as adjuvant treatment. The study aims to determine which combination is more effective at preventing the cancer from returning.

During the study, patients will receive their assigned treatment through an intravenous line (a thin tube inserted into a vein). The medications will be given in specific doses calculated based on each patient's body size. The treatment will be administered in cycles, with regular check-ups to monitor how well the treatment is working and to watch for any side effects.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your participation begins with checking if you meet the health requirements, including blood tests to verify organ function and CEA (a specific blood marker) levels.

    The treatment must start within 56 days after your colon surgery.

  2. Step 2

    Treatment group assignment

    You will be randomly assigned to receive one of two treatment combinations:

    Group 1: mFOLFOX - combination of oxaliplatin, folinic acid, and fluorouracil

    Group 2: mFOLFIRINOX - combination of oxaliplatin, folinic acid, fluorouracil, and irinotecan

    All medications will be given through an intravenous (into the vein) route

  3. Step 3

    Treatment period

    Regular medical visits will be scheduled to receive the treatment and monitor your health

    During visits, you will undergo physical examinations, vital signs checks, and blood tests

    Your doctor will monitor and record any side effects using a standardized classification system

  4. Step 4

    Follow-up period

    After completing treatment, you will be monitored for at least 3 years

    Regular check-ups will track your recovery and health status

    The main focus will be on checking for any signs of cancer return

    The study will continue until May 2026

Who can join the trial?

19 criteria

  • Age between 18 and 75 years
  • Must have high-risk stage III colon cancer that has been confirmed through testing
  • Must have undergone successful surgery that removed all visible cancer
  • Surgery must have been for a tumor located more than 12 cm from the anal opening
  • Treatment must begin within 56 days after surgery
  • No previous cancer chemotherapy treatment
  • No previous radiation treatment to the abdomen or pelvis area
  • Must have adequate organ function, including:
    • Healthy blood cell counts
    • Normal liver function
    • Good kidney function
    • Normal levels of potassium, magnesium, and calcium
    • Must have a CEA level (a blood test that measures cancer markers) of 10 ng/mL or less after surgery
    • For patients aged 18-71: must be able to perform light activities with occasional assistance (ECOG score ≤1)
    • For patients aged 71-75: must be fully active (ECOG score = 0)
    • Life expectancy of 5 years or more
    • Must use appropriate birth control if applicable
    • Must have health insurance (public or private)
    • Must be willing and able to follow study procedures
    • Must be able to understand and sign an informed consent form

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 75 years
  • Previous history of any other cancer within the last 5 years (except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix)
  • Active or chronic infection, including HIV, Hepatitis B, or Hepatitis C
  • Significant heart conditions, including heart failure, unstable angina (chest pain), or recent heart attack within 6 months
  • Severe kidney disease requiring dialysis
  • Severe liver disease
  • Untreated or unstable brain metastases (cancer spread to the brain)
  • Pregnant or breastfeeding women
  • Planning to become pregnant during the study period
  • Unable to follow study procedures or attend scheduled visits
  • Participation in another clinical trial within the past 30 days
  • Known allergic reactions to study medications or their components
  • Major surgery planned during the study period
  • Psychiatric conditions that could interfere with study compliance
  • Active autoimmune disease requiring systemic treatment
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Investigated drugs

FOLFIRINOX is a combination chemotherapy treatment that includes multiple medications working together to fight cancer cells. It contains fluorouracil, leucovorin, irinotecan, and oxaliplatin. This treatment is used to prevent cancer from returning after surgery in patients with high-risk colon cancer. FOLFOX is also a combination chemotherapy treatment, but with fewer components than FOLFIRINOX. It contains fluorouracil, leucovorin, and oxaliplatin. This treatment is commonly used in colon cancer patients after surgery to prevent the cancer from coming back. Both treatments are given through an intravenous (IV) line and are administered in cycles over several months to help prevent cancer recurrence after surgery for high-risk stage III colon cancer.

What is already known about the treatment

  • mFOLFIRINOX

    A combination chemotherapy regimen administered intravenously that consists of modified doses of fluorouracil, leucovorin, irinotecan, and oxaliplatin. This advanced treatment protocol is currently used in oncology for treating various types of cancer, particularly showing promise in high-risk stage III colon cancer in the adjuvant setting. The medication works by targeting rapidly dividing cancer cells through multiple mechanisms: inhibiting DNA synthesis, blocking topoisomerase I, and disrupting cell division processes. It belongs to the class of combination chemotherapy agents and represents an intensified version of standard chemotherapy protocols.

  • mFOLFOX

    A chemotherapy combination administered intravenously that includes modified doses of fluorouracil, leucovorin, and oxaliplatin. This well-established treatment protocol is widely used in colorectal cancer therapy and serves as a standard treatment option for stage III colon cancer in the adjuvant setting. The medication works primarily by interfering with DNA replication and cell division in cancer cells, with oxaliplatin forming cross-links in DNA and fluorouracil inhibiting essential enzymes needed for cell growth. It belongs to the antineoplastic combination chemotherapy class and is considered a cornerstone treatment in colorectal cancer management.

Investigated diseases

High-risk stage III colon cancer - A condition where cancer cells have spread from the colon wall to nearby lymph nodes but have not yet spread to distant parts of the body. The cancer has penetrated through the muscle layer of the colon and is considered aggressive due to specific features that increase the likelihood of recurrence. This stage of colon cancer develops when abnormal cells in the colon grow uncontrollably, forming tumors that invade through multiple layers of the colon wall. The cancer cells have reached at least four nearby lymph nodes but have not spread to distant organs. The term "high-risk" indicates the presence of certain characteristics that suggest a more aggressive form of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517489-41-00Protocol codeUC-0110/1609Estimated enrolment86 patientsSponsorUnicancer

sourced from the EU Clinical Trials Register and site verification

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