Chemoradiation for Locally Advanced and Low Rectal Cancers: Avastin-Capecitabine-Oxaliplatin-Radiation REctal Cancer Trial

Improved pre-operative therapy is required in the management of high risk rectal cancer in order to decrease local recurrence and increase the rate of sphincter sparing surgery. Capecitabine, oxaliplatin and bevacizumab represent new systemic agents and have been given safely in phase I and II trials concurrently with radiation with promising improvements in pCR rates of 15 -24% compared to historic rates of 8-14% achieved with 5-FU alone. Improvements in pCR rates have not been associated with an increase in post-operative complication rates. A trial of all three of these agents is justified due to their enhanced efficacy when given in combination as well as their non-overlapping treatment toxicity profile. This is a one-armed, multi-centred, Phase II study in patients with T3/4 locally advanced and T3/4 low lying rectal cancer, to study the efficacy and safety of the addition of bevacizumab to a regimen of capecitabine and oxaliplatin in combination with pre-operative radiation.