1616O Nab-paclitaxel plus gemcitabine versus modified FOLFIRINOX or S-IROX in metastatic or recurrent pancreatic cancer (JCOG1611, GENERATE): A multicentred, randomized, open-label, three-arm, phase II/III trial

Both nab-paclitaxel plus gemcitabine and modified FOLFIRINOX are equivalently recommended as first-line treatment for metastatic pancreatic cancer in patients with good performance status. S-IROX (S-1, irinotecan, and oxaliplatin) showed activity in a phase Ib study in this population. We therefore aimed to compare the efficacy and safety of these three regimens directly.