The German ESOPEC trial completed accrual in April 2020.
With n=438 patients it is comparing the CROSS-regime to perioperative FLOT-chemotherapy.
www.clinicaltrials.gov
OS is primary endpoint after a minimum of 36 months and the trial is powered to test superiority of FLOT.
They assume 55% 3-years OS with CROSS and are targetting for at least 68% with FLOT, a 13% absolute improvement of OS.
This assumption is quite optimistic in my view and mainly driven by the fact that the leading clinic in Freiburg has published 72% 3-years OS with FLOT.
My guess is that OS with CROSS will be higher than 55% and will actually close the gap to the FLOT-results and they will thus not be able to prove superiority of FLOT. A lot of the improvements we have seen in locally advanced esophageal cancer over the years were driven (similarly as in locally advanced NSCLC) not by better therapy but by stage migration.
I enjoy this comparison sometimes:
CROSS trial (Shapiro, Lancet Oncology 2015):
Michigan trial (Urba, JCO 2001)
The control arm in these two trials is identical: primary surgery.
The neoadjuvant experimental treatment arm is 41.4 Gy + Carboplatin/Paclitaxel or 45 Gy + Cisplatin/5-FU
It is nice to see how the OS in both arms of the Michigan-trial is HALF the OS of the corresponding Cross-trial arms.
This is driven by stage migration and possibly better therapeutic management (less deaths due to treatment, including surgery).