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.
1Initial 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.
2Treatment 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
3Treatment 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
4Follow-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 Study?
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 Study?
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
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.
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.
The website uses cookies to ensure the proper functioning of the site and to analyze internet traffic. Some cookies are essential for using the service and do not require consent. You can accept all cookies or use only the essential ones. Data is processed in accordance with our Privacy Policy. You have the right to withdraw your consent, access, rectify, delete, or limit the processing of your data at any time.
France 
Italy 
