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). (16th September 2022)

• Record Type: Journal Article
• Authors: Mizusawa, Junki; Ohba, Akihiro; Ozaka, Masato; Katayama, Hiroshi; Okusaka, Takuji; Kobayashi, Satoshi; Ikeda, Masafumi; Terashima, Takeshi; Sasahira, Naoki; Okano, Naohiro; Miki, Ikuya; Kaneko, Takashi; Mizuno, Nobumasa; Todaka, Akiko; Furukawa, Masayuki; Kajiura, Shinya; Kataoka, Tomoko; Fukuda, Haruhiko; Furuse, Junji; Ueno, Makoto
• Is Part Of: Japanese journal of clinical oncology. Volume 53:Number 1(2023)
• Page Start: 80
• Page End: 84
• Publication Date: 2022-09-16
• Subjects: metastatic pancreatic cancer -- gemcitabine plus nab-paclitaxel -- modified FOLFIRINOX -- S-IROX -- phase II/III study; Oncology -- Periodicals; Cancer -- Periodicals; 616.994005
• DOI: 10.1093/jjco/hyac146
• Languages: English
• ISSNs: 0368-2811

Abstract

Abstract: 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. This trial is registered with the Japan Registry of Clinical Trials [https://jrct.niph.go.jp/ ], number jRCTs031190009. Abstract : A randomized phase II/III trial 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 was started in April 2019.