Lower GI 2017

The Royal Marsden

Phase III – the phase III trial will be designed to detect an improvement in 3 year DFS in the intention to treat population from 74% to 82% (i.e. a hazard ratio of 0.66) with 80% power and a 5% 2- sided level of statistical significance. – 633 patients over 3-5 years – recruitment rate 5-11 patients (total from all sites) randomised per month