About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Written informed consent
Biopsy-proven rectal adenocarcinoma
Tumor located <12 cm from the anal verge
Disqualifiers
MRI-defined N1 or higher nodal disease
Distant metastases (M1)
MRI extramural vascular invasion (mriEMVI)
Threatened mesorectal fascia (≤1 mm on MRI)
Trial design
Treatments tested in this trial
- Capecitabine + Radiotherapy
- Total Mesorectal Excision (TME)
Treatment groups
Locations
Sponsors and collaborators
Vastra Gotaland Region
Lead sponsor
Skane University Hospital
Collaborator
Stockholm South General Hospital
Collaborator