421 / 1068
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