Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment

Rectal cancer is one of the most frequent malignant tumors nowadays. There are several possible treatment options including chemotherapy, radiotherapy and surgery. Surgery for early stage rectal cancer can be either a radical surgery (RS) or a local excision (LE). A radical surgery removes the rectum including the tumor and the lymph nodes through which it spreads, improving survival but with a possible impact in the patients quality of life (QoL). A local excision only removes the tumor and a safety margin of healthy rectum. This has the potential to avoid the possible complications and QoL decrease. However there are some complications after a LE and also poor prognostic factors inherent to the tumor biology that can lead the surgical team to perform a RS after LE with worse outcomes. These are impossible to know before the procedure. The goal of this registry is to determine the frequency of these poor prognostic biological factors and complications in patients undergoing LE for early rectal cancer. The main question it aims to answer are: • How frequently does LE allow for rectum preservation? Participants will undergo LE for early rectal cancer when it is considered the best treatment by their surgeons according to their expertise and protocols. Patients will follow the standard treatment that would be given to them, and the biological prognostic factors and the appearance of complications will be recorded.

NCT Number	NCT05927584
Lead Sponsor	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Collaborators: Hospital Alemão Oswaldo Cruz, Hospital Universitario La Fe, Complejo Hospitalario Universitario de Vigo
Conditions	Rectal Cancer, Rectum Neoplasm
Enrollment	145 participants
Start Date	2024-05-13
Primary Completion	2027-03-01 (estimated)
Study Completion	2027-05-01 (estimated)
Updated on ClinicalTrials.gov	2024-05-14