Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer

The goal of this one-arm clinical trial is to implement and study the oncological outcomes of nonoperative management of rectal cancer having complete clinical response to neoadjuvant therapy. The main questions to answer are * if the oncological results of nonoperative management after Nordic practice in chemoradiotherapy indications differ from experiences elsewhere * what is the organ preservation rate * what is the local regrowth rate

NCT Number	NCT06328361
Lead Sponsor	Tampere University Hospital Collaborators: Tampere University, Helsinki University Central Hospital, Turku University Hospital, Kuopio University Hospital, Oulu University Hospital, Jyväskylä Central Hospital, Seinajoki Central Hospital, Satakunta Central Hospital, North Karelia Central Hospital, Tartu University Hospital, East Tallinn Central Hospital, West Tallinn Central Hospital, North Estonia Medical Centre, Vaasa Central Hospital, Vaasa, Finland
Conditions	Rectal Cancer, Rectal Adenocarcinoma
Enrollment	200 participants
Start Date	2024-05-16
Primary Completion	2028-12-31 (estimated)
Study Completion	2032-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-09-02