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.
Germany 