Randomized phase III trial of intravenous and intraperitoneal paclitaxel with S-1 versus gemcitabine plus nab-paclitaxel for pancreatic ductal adenocarcinoma with peritoneal metastasis (SP study)
Tomohisa Yamamoto,
Tsutomu Fujii,
Satoshi Hirano,
Fuyuhiko Motoi,
Goro Honda,
Kenichiro Uemura,
Joji Kitayama,
Michiaki Unno,
Yasuhiro Kodera,
Hiroki Yamaue,
Toshio Shimokawa,
Daisuke Hashimoto,
So Yamaki,
Hideyuki Yoshitomi,
Fumihiko Miura,
Hideki Ueno,
Mitsugu Sekimoto,
Sohei Satoi,
on behalf of the Study Group of Pancreatic Ductal Adenocarcinoma with Peritoneal Metastasis
Affiliations
Tomohisa Yamamoto
Department of Surgery, Kansai Medical University
Tsutomu Fujii
Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama
Satoshi Hirano
Department of Gastroenterological Surgery II, Hokkaido University Faculty of Medicine
Fuyuhiko Motoi
Department of Surgery I, Yamagata University
Goro Honda
Department of Surgery, Institute of Gastroenterology, Tokyo Women’s Medical University
Kenichiro Uemura
Department of Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University
Joji Kitayama
Department of Surgery, Division of Gastroenterological, General and Transplant Surgery, Jichi Medical University
Michiaki Unno
Department of Surgery, Tohoku University Graduate School of Medicine
Yasuhiro Kodera
Gastroenterological Surgery, Nagoya University Graduate School of Medicine
Hiroki Yamaue
Second Department of Surgery, Wakayama Medical University, School of Medicine
Toshio Shimokawa
Clinical Study Support Center, Wakayama Medical University, School of Medicine
Daisuke Hashimoto
Department of Surgery, Kansai Medical University
So Yamaki
Department of Surgery, Kansai Medical University
Hideyuki Yoshitomi
Department of General Surgery, Graduate School of Medicine, Chiba University
Fumihiko Miura
Department of Surgery, Teikyo University Hospital
Hideki Ueno
Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital
Mitsugu Sekimoto
Department of Surgery, Kansai Medical University
Sohei Satoi
Department of Surgery, Kansai Medical University
on behalf of the Study Group of Pancreatic Ductal Adenocarcinoma with Peritoneal Metastasis
Abstract The prognosis of pancreatic ductal carcinoma (PDAC) with peritoneal metastasis remains dismal. Systemic chemotherapy alone may not be effective, and the combination of intraperitoneal chemotherapy with systemic chemotherapy is expected to prolong the overall survival in patients with peritoneal metastasis. We have designed a randomized phase III trial to confirm the superiority of intravenous (i.v.) and intraperitoneal (i.p.) paclitaxel (PTX) with S-1 relative to gemcitabine plus nab-PTX (GnP), which is the current standard therapy for patients with metastatic PDAC. A total of 180 patients will be accrued from 30 institutions within 3 years. Patients will be randomly assigned in a 1:1 ratio to receive either i.v. and i.p. PTX with S-1 or GnP (target of 90 patients per group). The primary endpoint is overall survival; secondary endpoints are progression-free survival, response rate, proportion with negative peritoneal washing cytology during chemotherapy, proportion requiring conversion surgery, and adverse event profiles. Japan Registry of Clinical Trials jRCTs051180199 ( https://jrct.niph.go.jp/ ).
