Statistical analyses
RECRUITMENT
A sample size of 35 patients was calculated to reject a null hypothesis defined as a median PFS of < 6.0 months and accept an alternative hypothesis defined as a median PFS ≥ 10.0 months, with a one-sided significance level of 0.10 and a power of 75%, assuming 5 years of recruitment and an additional 1.5 years of follow-up. In other words, FOLFIRINOX might be considered worthy of further evaluation in a randomized phase III trial if the lower limit value of 80% CI of the median PFS ≥ 6.0 months. All statistical analyses were performed using the program SAS (Statistical Analysis Software 9.4, SAS Institute Inc, Cary, North Carolina, USA).