This clinical trial is focused on studying colon cancer, specifically stage II colon cancer. The trial aims to improve the chances of staying free from the disease after treatment by using a combination of medications. The treatment being tested is called FOLFOX6m, which includes three main drugs: oxaliplatin, fluorouracil, and folinic acid. These medications are given through a drip into a vein, known as an intravenous infusion.
The purpose of the study is to see if this combination of drugs can help patients who have a specific marker in their blood, called circulating tumor DNA (ctDNA), which indicates a higher risk of cancer returning. The study will compare the outcomes of patients who receive the FOLFOX6m treatment with those who do not, to determine if the treatment is effective in preventing the cancer from coming back.
Participants in the study will receive the treatment over a period of six months. During this time, they will be monitored regularly to check their health and see how well the treatment is working. The study will also look at how long it takes for the cancer to return, if it does, and the overall survival of the patients. The trial is expected to continue until March 2026, with the goal of improving the long-term health of patients with stage II colon cancer.
1joining the study
Upon joining the study, a signed written informed consent is required. This consent confirms understanding and agreement to participate in the study.
Eligibility is confirmed based on specific criteria, including age, health status, and previous treatments.
2initial assessment
An initial assessment is conducted to ensure all eligibility criteria are met. This includes blood tests and imaging to confirm the absence of metastatic disease.
A negative pregnancy test is required for women of childbearing age.
3randomization
Participants are randomly assigned to different groups within the study. This process occurs up to 11 weeks after surgery.
4treatment administration
The treatment involves the administration of FOLFOX6m, which includes the medications oxaliplatin, fluorouracil, and folinic acid.
These medications are given through intravenous perfusion and injection.
5monitoring and follow-up
Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects.
Follow-up appointments are scheduled to evaluate Disease Free Survival (DFS) and other health outcomes.
6completion of the study
The study is estimated to conclude by March 31, 2026.
Final assessments are conducted to gather data on the primary and secondary endpoints, including overall survival and time to recurrence.
Who Can Join the Study?
Signed written informed consent obtained before any study-specific procedures.
No previous chemotherapy for colon or rectal cancer.
No previous radiation treatment to the abdomen or pelvis for colon or rectal cancer.
Life expectancy of at least 5 years.
Good blood health: with neutrophils (a type of white blood cell) of at least 1,500 per cubic millimeter, platelet count of at least 100,000 per cubic millimeter, and hemoglobin (a protein in red blood cells) of at least 9 grams per deciliter.
Total bilirubin (a substance made by the liver) no more than 1.5 times the upper limit of normal.
ASAT and ALAT (liver enzymes) no more than 2.5 times the upper limit of normal.
Alkaline phosphatase (an enzyme related to the liver) no more than 2.5 times the upper limit of normal.
Serum creatinine (a waste product in the blood) no more than 120 micromoles per liter or creatinine clearance (a measure of kidney function) of at least 50 milliliters per minute.
Carcinoembryogenic antigen (CEA, a protein that may be higher in cancer) no more than 1.5 times the upper limit of normal after surgery.
Negative pregnancy test for women who can have children.
Age between 18 and 80 years. For patients 70 years or older, a score greater than 14 on the G8 geriatric questionnaire is required.
Patient must be part of a social security system.
Confirmed stage II colon and high rectum adenocarcinoma (a type of cancer) without remaining disease after surgery. The tumor must be located at least 12 cm from the anal verge or above the peritoneal reflection.
At least 12 lymph nodes must have been analyzed.
Patients with MSI+ tumors (a specific type of tumor) can also be included.
All patients must have been discussed in multidisciplinary meetings with a decision not to perform additional chemotherapy.
No spread of cancer to other parts of the body as shown by a CT scan or liver MRI within 3 months before joining the study.
Joining the study planned up to 11 weeks after surgery with curative intent.
WHO performance status less than 2, meaning the patient is able to carry out all normal activities without assistance.
Who Cannot Join the Study?
Patients who do not have colon carcinoma. This is a type of cancer that affects the large intestine.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are part of a vulnerable population, which means they might need special protection or care.
FOLFOX6m is a combination chemotherapy treatment used in this clinical trial. It is designed to help improve the chances of being disease-free for patients with colon cancer at stage II who have tested positive for circulating tumor DNA (ctDNA). This treatment combines several drugs that work together to stop cancer cells from growing and dividing, which may help prevent the cancer from coming back after surgery.
Colon Carcinoma – Colon carcinoma is a type of cancer that begins in the large intestine, which is part of the digestive tract. It typically starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon. Over time, some of these polyps can become cancerous. As the disease progresses, it can invade and destroy normal tissue nearby and may spread to other parts of the body. Symptoms often include changes in bowel habits, blood in the stool, and abdominal discomfort. Early stages may not present noticeable symptoms, making regular screenings important for detection.
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