Outcomes
death
ADVERSE EVENTS, DISEASE, RECURRENCE, RECURRENCE
The primary endpoint was 3-year RFS. Secondary endpoints were 3-year OS rate, 5-year OS rate, 5-year RFS rate, and incidence of adverse events. OS is defined as the time from randomization to death from all causes. RFS is defined as the time from randomization to either disease recurrence or death from all causes. Recurrence was judged by imaging diagnosis and/or clinical relapse on the basis of non-imaging exacerbation of disease conditions. Late recurrence at > 3 years after surgery was analyzed independently and incidences were compared between the two arms.