Can Neoadjuvant Chemoradiotherapy be Ommited in Mid-rectal Cancer

This project aims to compare the oncological and functional outcomes of patients with mid-rectal cancer who have a low risk of local recurrence (without MRF involvement) and who either receive or do not receive neoadjuvant chemoradiotherapy (nCRT). Main Question: H0: In mid-rectal cancer patients without MRF involvement (cT2N+ and cT3Nx), there is no difference in 3-year disease-free survival between direct TME and TME after nCRT. H1: In mid-rectal cancer patients without MRF involvement (cT2N+ and cT3Nx), direct TME is associated with worse 3-year disease-free survival compared to TME after nCRT. Participants already taking both interventions as part of their regular medical care for rectal cancer will be recruited in a prospective database for 5 years.

NCT Number	NCT06823297
Lead Sponsor	Turkish Society of Colon and Rectal Surgery Collaborators: Baskent University, Dokuz Eylul University, Halic University, Acibadem Kent Hospital, Istanbul Health and Technology University
Conditions	Mid-Rectal Cancer, Rectal Cancer Stage II, Rectal Cancer Stage III
Enrollment	436 participants
Start Date	2025-08-01
Primary Completion	2030-08-01 (estimated)
Study Completion	2035-08-01 (estimated)
Updated on ClinicalTrials.gov	2025-06-27