(approximately between five to six years). The aim of
the first interim analysis is toxicity whereas the aim of
the second interim analysis is disease free survival and
overall survival as well as toxicity profile. The results of
the second interim analysis will not be the sole criteria
for deciding whether to terminate accrual or report the
results early. Rather they will provide a guideline to aid
in the decision, which will also take into account the
characteristics of the patients, nature of toxicities, relevant
external results. Most importantly, the sample size
will be re-estimated. Apart from the reason of safety,
which may caution otherwise, the minimum trial size
will remain as 2660 as initially planned.