TY - JOUR
T1 - 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
T2 - JCOG1611 (GENERATE)
AU - Hepatobiliary and Pancreatic Oncology Group of Japan Clinical Oncology Group
AU - Mizusawa, Junki
AU - Ohba, Akihiro
AU - Ozaka, Masato
AU - Katayama, Hiroshi
AU - Okusaka, Takuji
AU - Kobayashi, Satoshi
AU - Ikeda, Masafumi
AU - Terashima, Takeshi
AU - Sasahira, Naoki
AU - Okano, Naohiro
AU - Miki, Ikuya
AU - Kaneko, Takashi
AU - Mizuno, Nobumasa
AU - Todaka, Akiko
AU - Furukawa, Masayuki
AU - Kajiura, Shinya
AU - Kataoka, Tomoko
AU - Fukuda, Haruhiko
AU - Furuse, Junji
AU - Ueno, Makoto
N1 - Publisher Copyright:
© The Author(s) 2022. Published by Oxford University Press. All rights reserved.
PY - 2023/1/1
Y1 - 2023/1/1
N2 - 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 three-arm 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.
AB - 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 three-arm 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.
KW - gemcitabine plus nab-paclitaxel
KW - metastatic pancreatic cancer
KW - modified FOLFIRINOX
KW - phase II/III study
KW - S-IROX
UR - http://www.scopus.com/inward/record.url?scp=85175239538&partnerID=8YFLogxK
U2 - 10.1093/jjco/hyac146
DO - 10.1093/jjco/hyac146
M3 - 学術論文
AN - SCOPUS:85175239538
SN - 0368-2811
VL - 53
SP - 80
EP - 84
JO - Japanese Journal of Clinical Oncology
JF - Japanese Journal of Clinical Oncology
IS - 1
ER -
