Protocol of a randomized phase II/III study of gemcitabine plus nab-paclitaxel combination therapy versus modified FOLFIRINOX versus S-IROX for metastatic or recurrent pancreatic cancer: JCOG1611 (GENERATE)

Gemcitabine plus nab-paclitaxel and combination chemotherapy with fluorouracil, leucovorin, irinotecan and oxaliplatin are a standard treatment for metastatic or recurrent pancreatic cancer. Recent studies on metastatic pancreatic cancer have demonstrated promising results of modified fluorouracil, leucovorin, irinotecan and oxaliplatin and S-1, irinotecan and oxaliplatin. A threearm randomized phase II/III trial has been conducted since April 2019 to confirm the superiority of modified fluorouracil, leucovorin, irinotecan and oxaliplatin and S-1, irinotecan and oxaliplatin over Gemcitabine plus nab-paclitaxel in patients with metastatic or recurrent pancreatic cancer. A total of 732 patients will be enrolled from 42 Japanese institutions within 5 years. The primary endpoint is the response rate in the S-1, irinotecan and oxaliplatin arm for phase II portion and overall survival for phase III portion. The secondary endpoints for phase III portion are progression-free survival, response rate, adverse events, serious adverse events and dose intensity.