This clinical trial is focused on studying treatments for colon cancer, specifically in patients aged 70 and older who have undergone surgery to remove stage III colon cancer. The study aims to evaluate the effectiveness of different chemotherapy treatments in preventing the return of cancer after surgery. The main goal is to compare how well patients do without the cancer coming back over a period of three years.
The treatments being studied include several medications: Elvorine (levoleucovorin), Xeloda (capecitabine), Folinic acid (as calcium folinate), and Fluorouracil. Elvorine is given as an injection, Xeloda is taken as a tablet, and both Folinic acid and Fluorouracil are administered through an injection or infusion. These medications are used in combination with chemotherapy to help prevent the cancer from returning.
Participants in the study will receive one of the treatment strategies and will be monitored over a period of time to assess their health and any side effects. The study will also look at how well patients tolerate the treatments, how long it takes for the cancer to return, and the overall survival of the patients. Additionally, the study will consider the impact of the treatments on the patients’ quality of life and independence. The trial is expected to continue until August 2025.
1introduction to the trial
Upon joining the study, the patient will be informed about the trial’s purpose, which is to evaluate chemotherapy after surgery for stage III colon cancer in patients aged 70 and older.
The patient will be required to provide informed consent, confirming understanding and agreement to participate in the trial.
2eligibility confirmation
Eligibility will be confirmed based on criteria such as age (70 or older), recent surgery for stage III colon cancer, and no prior chemotherapy for colon cancer.
The patient must be deemed fit to receive chemotherapy and complete initial geriatric assessments.
3randomization
The patient will be randomly assigned to one of two treatment strategies to compare their effectiveness in preventing cancer recurrence.
4treatment administration
The patient will receive chemotherapy, which may include medications such as levoleucovorin, capecitabine, folinic acid, and fluorouracil.
Levoleucovorin and fluorouracil will be administered through intravenous perfusion, while capecitabine will be taken orally as film-coated tablets.
The specific dosage and frequency will be determined by the medical team based on the patient’s condition and response to treatment.
5monitoring and follow-up
The patient’s health and response to treatment will be regularly monitored to assess the effectiveness and tolerance of the chemotherapy.
Regular follow-up appointments will be scheduled to evaluate the patient’s progress and any potential side effects.
6completion of the trial
The trial is expected to continue until August 31, 2025, with the primary goal of assessing relapse-free survival at three years.
Upon completion, the patient’s overall health, quality of life, and any recurrence of cancer will be evaluated.
Who Can Join the Study?
Must be 70 years old or older.
Male patients must use effective contraception during treatment and for at least 6 months after stopping a specific medication called oxaliplatin.
Must have signed a consent form to participate in the study.
Must be considered fit to receive chemotherapy by a medical team.
Must have a Lee’s score evaluated and sent to the research team. This is a way to assess health status.
Must have stage III upper rectal or colon adenocarcinoma, which is a type of cancer in the colon or rectum.
Must have had a successful surgery to remove the primary tumor, known as resection R0.
Must be able to start chemotherapy within 12 weeks after surgery.
Must not have had any prior chemotherapy for colon cancer.
Must complete an initial geriatric self-questionnaire and send it to the research team. This is a survey about personal health and well-being.
Must complete an initial geriatric team questionnaire and send it to the research team. This is a survey filled out by a healthcare team about the patient’s health.
Who Cannot Join the Study?
Patients who have not had surgery to remove stage III upper rectal or colon cancer.
Patients under the age of 70.
Patients with medical conditions other than colon cancer.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Adjuvant Chemotherapy is a treatment given after the primary treatment, such as surgery, to lower the risk of the cancer coming back. In this trial, it is used for patients aged 70 and older who have had surgery for stage III colon cancer. The chemotherapy helps to kill any remaining cancer cells and aims to improve the chances of staying cancer-free.
Colon Cancer – Colon cancer is a type of cancer that begins in the large intestine, which is the final 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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