ホンダ　ゴロウ   HONDA Gorou   本田　五郎    所属   医学部 医学科（東京女子医科大学病院）    職種   教授・基幹分野長
論文種別	原著
言語種別	英語
査読の有無	査読なし
表題	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).
掲載誌名	正式名：Trials 略　 称：Trials ISSNコード：17456215/17456215
掲載区分	国外
巻・号・頁	23(1),pp.119
著者・共著者	Yamamoto Tomohisa, Fujii Tsutomu, Hirano Satoshi, Motoi Fuyuhiko, Honda Goro, Uemura Kenichiro, Kitayama Joji, Unno Michiaki, Kodera Yasuhiro, Yamaue Hiroki, Shimokawa Toshio, Hashimoto Daisuke, Yamaki So, Yoshitomi Hideyuki, Miura Fumihiko, Ueno Hideki, Sekimoto Mitsugu, Satoi Sohei,
発行年月	2022/02
概要	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/ ).
DOI	10.1186/s13063-022-06049-7
PMID	35123553