This clinical trial is focused on studying early-stage rectal cancer, which is a type of cancer that affects the lower part of the large intestine. The study aims to explore different treatment options to preserve the rectum, which is the final section of the large intestine. The treatments being investigated include a combination of radiation therapy and additional treatments, such as medications or surgery. The medications used in this study are Oxaliplatin and Capecitabine. Oxaliplatin is a type of chemotherapy drug that is administered through an intravenous infusion, meaning it is given directly into a vein. Capecitabine is another chemotherapy drug that is taken orally, meaning it is swallowed in pill form.
The purpose of the study is to assess how well these treatments can help preserve the rectum in patients with early-stage rectal cancer. Participants in the study will receive either the treatment with Oxaliplatin and Capecitabine or a placebo. The study will follow participants over a period of time to monitor the effectiveness of the treatment and any side effects that may occur. The study will also look at how the treatment affects the quality of life of the participants, including any changes in bowel, bladder, and sexual function.
Throughout the study, participants will undergo regular check-ups and assessments to track their progress. The study will last for several years, with the main goal of determining the success rate of organ preservation at 24 months from the start of treatment. Additionally, the study will evaluate other outcomes, such as the rate of cancer regrowth and overall survival of the participants. This research aims to provide valuable insights into the best treatment approaches for preserving the rectum in patients with early-stage rectal cancer.



The Netherlands