448 / 1851
Recruitment and number of patients
Estimated gain: 12% in loco-regional control.
(Alpha 0.05, beta 0.2, 5-year hazard rate: 80%)
Needed number of events: 282
Estimated number of patients: 600
Start June 1, 2002.
Estimated recruitment time: 3 years (200 pts/year).
Planned interim analysis after 150 events.
DAHANCA 10 randomized phase III
Overgaard et al ICHNO 2013