Statistical analysis
CFS
ADVERSE EVENTS, SECONDARY
The primary objective of this study was to estimate the 2-year DFS and 95% confidence interval (CI). Thus, 36 patients were required to be enrolled in this study, with planned accrual of 3 years and follow-up of 2 years after the accrual completion. This sample size was considered sufficient to estimate 95% CIs for the true 2-year DFS within a width of +15% when the expected true 2-year DFS was 70%. The secondary endpoints were 2-year overall survival (OS), LC, colostomy-free survival (CFS) and adverse events. Patients who underwent colostomy before treatment were considered colostomy-free if colostomy closure was performed within 1 year after study entry. All the endpoints were measured from the time of study entry to the date of first treatment failure for the given endpoint or to the date of the last follow-up for patients in whom an endpoint did not result in failure. DFS, OS, LC and CFS were estimated using the Kaplan–Meier method.