Evaluating the use of capecitabine, oxaliplatin, fluorouracil, folinic acid, and irinotecan to personalize chemotherapy for patients with stage III colorectal cancer

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What is this study about?

This study focuses on individuals with Stage III colorectal cancer, a type of cancer located in the large intestine or rectum that has spread to nearby lymph nodes. The purpose of the study is to determine the best way to use adjuvant chemotherapy, which is treatment given after surgery to help prevent the cancer from coming back. To help make these decisions, a blood test is used to look for circulating tumor DNA, which refers to small pieces of genetic material from a tumor that are found floating in the bloodstream.

Participants are divided into two groups based on their blood test results. For those who do not have detectable tumor DNA in their blood, the study compares a 6-month course of capecitabine alone to a 3-month course of oxaliplatin combined with capecitabine. For those who do have detectable tumor DNA, the study compares a 6-month course of fluorouracil, irinotecan, oxaliplatin, and calcium folinate to a 6-month course of fluorouracil, oxaliplatin, and calcium folinate. Calcium folinate is a substance used to help the other medications work more effectively.

During the study, the effectiveness of these treatments is monitored by looking at disease-free survival, which is the length of time a patient lives without any signs or symptoms of the cancer returning. The study also tracks overall survival and any side effects caused by the medications, such as neurotoxicity, which is damage to the nerves that can cause issues like tingling or numbness. The course of the study involves receiving the assigned medication through pills or an intravenous infusion, which is a method of delivering medicine directly into a vein through a tube.

Who Can Join the Study?

You must be between 18 and 79 years old, or if you are 70 years or older, you must score higher than 14 on the G8 geriatric questionnaire, which is a tool used to check the general health and well-being of older adults.
You must have a confirmed diagnosis of stage III colon or upper rectum cancer that has been examined by a doctor under a microscope.
The cancer must be pMMR/MSS, which means the cancer cells have specific characteristics regarding how they repair their DNA.
There must be no visible or microscopic signs of cancer left in the body after your surgery.
A CT scan or liver MRI (specialized imaging tests to look at the inside of the body) performed within the last 2 months must show that the cancer has not spread to other parts of the body.
You must be able to join the study between 10 days and 6 weeks after your surgery.
You must have an ECOG performance status of 0 or 1, which means you are physically strong enough to perform daily activities and receive the study treatment.
You must not have received any chemotherapy (drugs used to kill cancer cells) or radiation (high-energy beams used to destroy cancer) for this specific cancer before.
You must have adequate blood counts, meaning your levels of neutrophils (white blood cells that fight infection), platelets (cells that help blood clot), and hemoglobin (a protein in red blood cells that carries oxygen) are within safe ranges.
Your liver function tests, including total bilirubin, ASAT, ALAT, and alkaline phosphatase (different measurements used to check how well your liver is working), must be within normal limits.
Your kidney function, measured by serum creatinine or creatinine clearance (tests that show how well your kidneys filter waste from your blood), must be at a healthy level.
Tumor tissue samples must be available for testing at the start of the study.
You must provide written informed consent, which is a signed document showing you understand and agree to participate.
Women who are able to become pregnant must have a negative pregnancy test within 7 days before starting treatment.
Both men and women who can become pregnant must agree to use effective contraception (methods to prevent pregnancy) during the study and for 6 months after the treatment ends.
You must be able to follow the study plan, including attending all scheduled visits, taking medications as directed, and completing laboratory tests.
You must have social security or equivalent health coverage as required by local laws.

Who Cannot Join the Study?

You have peripheral neuropathy, which is nerve damage that causes numbness, tingling, or pain in your hands or feet.
You have a history of other cancers, except for certain skin cancers or cervical cancers that have been treated, or other cancers that have been gone for at least 5 years.
You are pregnant or currently breastfeeding.
You are unable or unwilling to follow the medical follow-up schedule due to your location, family, social, or mental health needs.
You are currently in custody or under legal guardianship.
You have already received neo-adjuvant treatment, which is therapy given before the main treatment (such as surgery) to shrink a tumor.
You have other health problems that could affect how long you live, such as cardiovascular disease (heart problems) like a heart attack in the last year or unstable heart disease.
You have reasons why you cannot receive chemotherapy, such as problems with your bone marrow (the part of your body that makes blood cells), liver function, or kidney function, or an allergy to the medicine or its ingredients.
You have previously had a bone marrow transplant.
You have received a blood transfusion within the last 3 months.
You are already participating in another medical study.
You have a dihydropyrimidine dehydrogenase (DPD) deficiency, which is a condition where your body lacks a specific enzyme (a protein that helps with chemical reactions) needed to break down certain medicines.
Your tumor is MSI/dMMR, which refers to specific genetic characteristics of the cancer cells.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country
University Of Skane	Malmo	Sweden
Karolinska University Hospital	Solna	Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Soedersjukhuset AB	Stockholm	Sweden
Unzaszp Ukdohabzsk Hnbhqtqc	Uppsala	Sweden

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	16.03.2026
Sweden	Not yet recruiting	16.03.2026

Trial locations

Investigated drugs:

Capecitabine is a pill taken by mouth that is used as a chemotherapy medication to help treat cancer cells.

Fluorouracil is a chemotherapy medication given through a vein into the bloodstream to help kill cancer cells.

Irinotecan is a chemotherapy medication administered through a vein to help treat cancer.

Oxaliplatin is a chemotherapy medication given through a vein to help fight cancer cells.

Leucovorin is a medication given through a vein that is used alongside certain chemotherapy drugs to make them work more effectively.

Investigated diseases:

Colorectal cancer stage III

Colorectal cancer – This disease is a type of cancer that begins in the tissues of the colon or the rectum. It often starts as small, noncancerous growths called polyps on the inner lining of the digestive tract. Over time, these polyps can change into malignant tumors that grow into the walls of the intestine. As the disease progresses, the cancer cells may spread to nearby lymph nodes or other parts of the body. The condition can affect different stages of the bowel depending on how deeply the cells have invaded.

Trial ID:

2025-521045-24-00

Protocol code:

UC-GIG-2410

Trial Phase:

Therapeutic confirmatory (Phase III)

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Evaluating the use of capecitabine, oxaliplatin, fluorouracil, folinic acid, and irinotecan to personalize chemotherapy for patients with stage III colorectal cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?