No Surgery Trial / Two Dose-escalation Strategies

It is becoming clear that there is a now an international consensus that rectal cancer

research efforts need to be more focused in optimizing a non-surgical approach. This

concept is very relevant to an ageing patient population with multiple co-morbidities

regularly seen at the Jewish General Hospital and across the province. After interim

analysis on 40 patients of the pilot study a phase III study is proposed. We are

therefore proposing a phase III multicentric study of 145 patients to compare the two

best known radiation dose escalation strategies and to achieve a complete clinical

response. 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). Patients that have a high risk of

recurrence or with more advanced stages of the disease will be excluded from the study,

as only the local disease is being treated. The primary outcome for this proposal is

rectum preservation in treated patients.