Next Generation STAR-TREC (NG-ST) - Organ Preservation in Early Rectal Cancer

This study evaluates whether mesorectal chemoradiotherapy with a limited radiation target volume can achieve a sustained clinical complete response in patients with early-stage rectal cancer, allowing surgery to be safely deferred. Patients may choose between standard total mesorectal excision (TME) surgery or organ preservation with chemoradiotherapy followed by structured surveillance. The study aims to assess oncologic safety, organ preservation rates, and quality of life.

NCT Number	NCT07483060
Lead Sponsor	Vastra Gotaland Region Collaborators: Skane University Hospital, Stockholm South General Hospital
Conditions	Rectal Cancer
Enrollment	90 participants
Start Date	2026-03-12
Primary Completion	2028-12-31 (estimated)
Study Completion	2031-12 (estimated)
Updated on ClinicalTrials.gov	2026-03-19