Interim analyses
tumour
ADVERSE EVENTS, RECURRENCE, RECRUITMENT, TUMOUR
Patient recruitment status will be reviewed every 4 months in planned investigator meetings in which interim analyses will be carried out. If the accrual rate is slower than expected, the principal investigator and co-investigators will discuss the possible reasons and ways to improve the recruitment rate. The interim analyses will not be affected by the results. A data-monitoring group will consist of two independent, external experts who will be responsible for monitoring the progress of the study. If there are significantly more serious adverse events associated with either group after 1 year of commencement of the study, the trial will be terminated as decided by the principal investigator and the data-monitoring group. The same will be applied to the situation where the difference in tumour recurrence between groups is significantly less than expected. The final analysis of the trial will be carried out on an intention-to-treat basis.