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.

Automated summary

Gemcitabine plus nab-paclitaxel and combination chemotherapy with fluorouracil, leucovorin, irinotecan and oxaliplatin are standard treatments for metastatic or recurrent pancreatic cancer. Recent studies have shown promising results for modified fluorouracil, leucovorin, irinotecan and oxaliplatin and S-1, irinotecan and oxaliplatin.