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).
Rectal cancer patients, clinically staged as T2-T3a,b N0-1 by MRI or endoscopic/trans-rectal ultrasound
Rectal cancer staged as N0-1 by MRI or EUS/TRUS
No metastatic lesion
Rectal tumor occupying less than half of the circumference
Patients with previous pelvic radiation
Evidence of distant metastasis
Extension of malignant disease to the anal canal
Tumors staged as T4
Sir Mortimer B. Davis - Jewish General Hospital
Lead sponsor