762 / 1068
Prospect Study Endpoints
Primary Outcomes:
•
Randomized Phase II Component (366 patients
with early stopping rule if failure to complete R0
resections or if high rate of Local Recurrence)
–
R0 Resection Rate
–
Time to local recurrence (TLR
)
•
Phase III Component (644 additional patients) :
Co-primary endpoints
–
Time to local recurrence (TLR)
–
Disease free survival (DFS)