This clinical trial is focused on studying the effects of pre-operative treatment in patients with colon cancer. The trial involves patients whose cancer is at an advanced stage, specifically stages T3-4, and/or those with positive lymph nodes as identified by CT or MRI scans, but without cancer spread to distant parts of the body. The purpose of the study is to compare the effectiveness of chemotherapy given before surgery with the standard approach of surgery followed by additional treatment based on the cancer stage.
The study will use several medications, including Disodium Folinate, Oxaliplatin, Fluorouracil, Irinotecan, Capecitabine, and Calcium Folinate. These medications are administered either as solutions for infusion, which means they are given directly into the bloodstream, or as tablets taken by mouth. Some participants will receive these medications, while others may receive a placebo. The trial will last for a maximum of 24 months, during which the participants will receive the treatment and be monitored for their response to it.
The main goal is to see if the pre-operative chemotherapy can improve the time patients remain free from the disease, known as disease-free survival. This means the study will look at whether patients have no surgery, no resection, incomplete resection, new metastases, local relapse, or death from any cause after starting the trial. The trial aims to provide valuable information on whether starting treatment before surgery can offer better outcomes for patients with advanced colon cancer.
1joining the trial
Upon joining the trial, you will be asked to provide your signed informed consent. This confirms your understanding and agreement to participate in the study.
2initial assessments
You will undergo initial assessments to ensure you meet the eligibility criteria. This includes blood tests to check your bone marrow, liver, and kidney function, as well as imaging tests like CT or MRI scans to confirm the stage of your colon cancer.
3treatment plan discussion
A detailed discussion about your treatment plan will take place. The main objective is to compare the effectiveness of chemotherapy before surgery versus surgery followed by chemotherapy.
4preoperative chemotherapy
If you are assigned to receive chemotherapy before surgery, you will be given medications such as disodium folinate, oxaliplatin, fluorouracil, irinotecan, capecitabine, and calcium folinate. These medications are administered through an infusion, except for capecitabine, which is taken orally. The specific dosage, frequency, and duration will be explained to you by your healthcare team.
5surgery
After completing the preoperative chemotherapy, you will undergo surgery to remove the cancerous tissue. The timing and specifics of the surgery will be determined by your medical team.
6postoperative care
Following surgery, you will receive postoperative care to aid your recovery. This may include additional chemotherapy based on the stage of your cancer and your overall health.
7follow-up assessments
Regular follow-up assessments will be conducted to monitor your health and the effectiveness of the treatment. These assessments may include physical exams, blood tests, and imaging studies.
8end of trial participation
Your participation in the trial will conclude after the final follow-up assessments. The results of the trial will contribute to understanding the best treatment approach for advanced colon cancer.
Who Can Join the Study?
Signed informed consent from the patient.
Patient must be at least 18 years old.
Confirmed diagnosis of adenocarcinoma (a type of cancer) of the colon or upper rectum.
Tumor must be mismatch-repair proficient and/or microsatellite stable, which means the tumor has certain genetic characteristics.
Intent to have surgery that aims to cure the cancer.
Cancer must be at stage T3 or T4 and/or have nodal positivity (N+), which means the cancer has spread to nearby tissues or lymph nodes, as shown by a CT or MRI scan.
No evidence of cancer spreading to distant parts of the body, as determined by recent medical evaluations.
No significant active wound healing issues, such as severe chronic wounds or untreated bone fractures.
Patient must have an ECOG performance status of 0-2, which is a scale used to assess how well a patient can perform daily activities.
Patient must have adequate function of bone marrow, liver, and kidneys, as shown by specific blood test results.
If not on blood thinners, patient must have certain blood clotting test results within normal limits. Patients on blood thinners are allowed.
Patient must have normal fluorouracil metabolism, which means they can process certain chemotherapy drugs without unusual side effects.
Women who can become pregnant must have a negative pregnancy test and agree to use effective birth control during the study and for 6 months after. Men must also agree to use birth control and not donate sperm during this time.
Who Cannot Join the Study?
Patients with distant metastases (cancer that has spread to other parts of the body) cannot participate.
Patients who are not diagnosed with colon cancer staged T3-4 or do not have nodal positive status (cancer that has spread to nearby lymph nodes) by CT or MRI scan are excluded.
Preoperative Chemotherapy is a treatment given before surgery to help shrink the tumor in advanced colon cancer. This therapy involves using drugs that target and kill cancer cells, making it easier to remove the tumor during surgery. The goal is to improve the chances of a successful surgery and reduce the risk of cancer coming back.
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. The disease progresses as the cancer cells grow and invade the walls of the colon, potentially spreading to nearby lymph nodes. In advanced stages, colon cancer can spread to other parts of the body, such as the liver or lungs. The progression of the disease is often categorized by stages, with T3-4 indicating more advanced local growth and nodal involvement suggesting spread to nearby lymph nodes.
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