Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery

A randomized study of 131 patients. Patients with a clinical T2-3 N0-1 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions).

NCT Number	NCT03051464
Lead Sponsor	Sir Mortimer B. Davis - Jewish General Hospital
Conditions	Stage II Rectal Cancer, Organ Preservation, Non-operative Treatment, Rectal Cancer (Stage III), Rectal Cancer Patients
Enrollment	131 participants
Start Date	2017-04-25
Primary Completion	2028-01 (estimated)
Study Completion	2030-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-30