Lower GI 2017

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)