• Junki Mizusawa, Akira Fukutomi, Hiroshi Katayama, Hiroshi Ishii, Tatsuya Ioka, Takuji Okusaka, Hideki Ueno, Makoto Ueno, Masafumi Ikeda, Nobumasa Mizuno, Masato Ozaka, Haruhiko Fukuda, Junji Furuse, and Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group.
• JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
• Pancreatology. 2018 Oct 1; 18 (7): 841-845.

AbstractGemcitabine is one of the standard treatments for locally advanced pancreatic cancer. Recent studies on metastatic pancreatic cancer have shown that combination chemotherapy with oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) and gemcitabine plus nab-paclitaxel (GnP) prolonged the overall survival compared with gemcitabine alone. To select the most promising chemotherapy, a randomized phase II selection design trial was started in July 2016 to compare between modified FOLFIRINOX and GnP for patients with locally advanced pancreatic cancer. A total of 124 patients will be enrolled from 36 Japanese institutions within 2.5 years. The primary endpoint is the proportion of 1-year overall survival, and secondary endpoints are progression-free survival, distant metastasis-free survival, response rate in patients with target lesions, CA19-9 response, adverse events, treatment-related death, early death, grade 4 non-hematological toxicity, and dose intensity. This trial has been registered with the UMIN Clinical Trials Registry [http://www.umin.ac.jp/ctr/index.htm], and the registration number is UMIN000023143.Copyright © 2018. Published by Elsevier B.V.

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