Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSir Mortimer B. Davis - Jewish General Hospital

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

Patients with previous pelvic radiation

Evidence of distant metastasis

Extension of malignant disease to the anal canal

Tumors staged as T4

Trial design

Treatments tested in this trial

  • Complete responders and Non-complete responders
  • Chemoradiation + EBRT Boost
  • Chemoradiation + HDRBT Boost

Treatment groups

131 Participants
are divided into 2 treatment groups