Randomized phase III trial of gemcitabine plus nab-paclitaxel versus gemcitabine plus S-1 as neoadjuvant chemotherapy for resectable pancreatic cancer in geriatric patients: JCOG2101C (PRESTIGE study)
Neoadjuvant gemcitabine plus S-1 (GS) followed by surgery and adjuvant S-1 is the standard of care for resectable pancreatic cancer. Since ~73% of newly diagnosed pancreatic cancer patients are aged ≥70, effective treatments are strongly needed in this geriatric population. In unresectable pancreatic cancer, gemcitabine plus nab-paclitaxel (GnP) is widely used, even among geriatric patients. To evaluate the survival advantage of neoadjuvant GnP over GS for geriatric patients with resectable pancreatic cancer, an open-label randomized phase III trial (JCOG2101C) has been initiated since October 2022. A total of 400 patients will be enrolled from 28 institutions within 3 years. The primary endpoint is overall survival. This trial was registered at the Japan Registry of Clinical Trials as jRCTs031220351 [https://jrct.mhlw.go.jp/latest-detail/jRCTs031220351].
Authors
- Shigeru Marubashi (ORCID: https://orcid.org/0000-0002-5263-3286)
- Noriko Mitome (ORCID: https://orcid.org/0009-0000-0082-9028)
- Y. Sano (ORCID: https://orcid.org/0000-0001-7753-8712)
- Seiko Hirono (ORCID: https://orcid.org/0000-0003-3054-1038)
- Kazuaki Harada (ORCID: https://orcid.org/0000-0001-9577-1884)
- Masaaki Murakawa (ORCID: https://orcid.org/0000-0001-6140-7953)
- Tsutomu Fujii (ORCID: https://orcid.org/0000-0003-0625-1911)
- N. Okano
- Nobumasa Mizuno (ORCID: https://orcid.org/0000-0001-9704-1885)
- Hidetoshi Eguchi (ORCID: https://orcid.org/0000-0002-2318-1129)
- Yuichi Nagakawa
- Keiko Kamei (ORCID: https://orcid.org/0000-0001-8846-7120)
- Taro Okazaki
- Toru Otsuru (ORCID: https://orcid.org/0000-0001-7615-3124)
- Shintaro Yagi
- Hirofumi Shirakawa
- Shiho Arima
- T. Mizui
- M. Ueno
- Satoru Seo
- Shinjiro Kobayashi
- Shuichi Aoki
- Masato Ozaka
- Naoto Gotohda
- Naoki Ikenaga
- Shingo Kagawa
- Manabu Kawai
- Haruhiko Fukuda
- Hidenori Takahashi
- Shogo Nomura
- Michiaki Unno
- Etsuro Hatano
- Amane Takahashi
- Hirofumi Akita
Institutions
- Kanazawa University (JP)
- Kagoshima University (JP)
- Osaka Gakuin University (JP)
- Fukushima Medical University (JP)
- Kyushu University (JP)
- Hyogo Medical University (JP)
- Tokyo Medical University (JP)
- St. Marianna University School of Medicine (JP)
- Yamaguchi University (JP)
- Wakayama Medical University (JP)
- Kyorin University (JP)
- Tohoku University (JP)
- Kyoto University (JP)
- Kanagawa Prefectural Hospital Organization (JP)
- National Cancer Centre Japan (JP)
- Kochi Medical School Hospital (JP)
- National Cancer Center (US)
- Osaka International Cancer Institute (JP)
- Kindai University Sakai Hospital (JP)
- Chiba Cancer Center (JP)
- Saitama Cancer Center (JP)
- Tochigi Cancer Center (JP)
- Aichi Cancer Center (JP)
- Shikoku Cancer Center (JP)
- Hokkaido University Hospital (JP)
- National Cancer Center Hospital East (JP)
- Japan Clinical Cancer Research Organization (JP)
- Hyogo Prefectural Cancer Center (JP)
- Japanese Foundation For Cancer Research (JP)
- University of Toyama (JP)
- The University of Tokyo (JP)
- Kindai University (JP)
- The University of Osaka (JP)
Publication Details
- Journal
- Japanese Journal of Clinical Oncology
- Published
- 2026-04-02
- DOI
- https://doi.org/10.1093/jjco/hyag055
- Primary Topic
- Pancreatic and Hepatic Oncology Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00