S1505, A Randomized Phase II Study of Perioperative mFolfirinox Versus Gemcitabine/Nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma (CTMS# 15-2140)
a. To assess 2-year overall survival in each treatment arm (mFOLFIRINOX and gemcitabine/nab-paclitaxel) in patients with resectable pancreatic cancer.
b. If the stated threshold is met in one or both arms: to choose the better regimen with respect to 2-year overall survival.
To estimate, for all patients and within treatment arms:
a. Frequency and severity of adverse events associated with chemotherapy in the perioperative setting.
b. Proportion of patients going to surgery for resection after preoperative chemotherapy.
c. Proportion of patients achieving R0 resection after preoperative chemotherapy.
d. Overall response rate following preoperative chemotherapy, including confirmed and unconfirmed, complete and partial response, per RECIST 1.1.
e. Pathologic response rates after R0 or R1 resection.
f. Patterns of recurrence (loco-regional, distant) after R0 or R1 resection.
g. Disease-free survival from the time of R0 or R1 resection.