This clinical trial is focused on studying treatments for intermediate and high-risk rectal cancer. The study compares two different approaches: short course radiotherapy and chemoradiotherapy, both followed by additional chemotherapy. The goal is to explore the possibility of preserving the rectum without major surgery or the need for a stoma, which is an opening created in the abdomen to allow waste to leave the body. The trial involves several medications, including Fluorouracil, Calcium Folinate Pentahydrate, Capecitabine, and Oxaliplatin. These medications are used in different forms, such as injections and tablets, to help treat the cancer.
The purpose of the study is to determine if these treatments can improve the rate of organ preservation, meaning the rectum remains intact without the need for major surgery. Participants will receive either the short course radiotherapy or chemoradiotherapy, followed by consolidation chemotherapy, which is additional treatment to help strengthen the effects of the initial therapy. The study will monitor the participants over a period to assess the effectiveness of the treatments in preserving the rectum and improving survival rates.
Throughout the study, participants will undergo various procedures, including MRI scans, to evaluate the progress of the treatment. The trial aims to improve the 3-year organ preservation rate from 30% to 40% in patients receiving the investigational treatment. This research is part of a larger effort by the German Rectal Cancer Study Group to find better ways to treat rectal cancer while minimizing the need for invasive surgeries.



Germany