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)

Trials

Toshio Shimokawa¹  Satoshi Hirano²  Hideyuki Yoshitomi³  Fuyuhiko Motoi⁴  Tsutomu Fujii⁵  Joji Kitayama⁶  Kenichiro Uemura⁷  Goro Honda⁸  Sohei Satoi⁹  So Yamaki⁹  Daisuke Hashimoto⁹  Tomohisa Yamamoto⁹  Mitsugu Sekimoto⁹  Fumihiko Miura^1,10  Michiaki Unno^1,11  Yasuhiro Kodera^1,12  Hideki Ueno^1,13  Hiroki Yamaue^1,14 

[1] Clinical Study Support Center, Wakayama Medical University, School of Medicine, Wakayama, Japan;Department of Gastroenterological Surgery II, Hokkaido University Faculty of Medicine, Sapporo, Japan;Department of General Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan;Department of Surgery I, Yamagata University, Yamagata, Japan;Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama, Toyama, Japan;Department of Surgery, Division of Gastroenterological, General and Transplant Surgery, Jichi Medical University, Tochigi, Japan;Department of Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan;Department of Surgery, Institute of Gastroenterology, Tokyo Women’s Medical University, Tokyo, Japan;Department of Surgery, Kansai Medical University, 2-3-1, Shin-machi, Hirakata, 573-1191, Osaka, Japan;Department of Surgery, Teikyo University Hospital, Mizonokuchi, Kawasaki, Japan;Department of Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan;Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan;Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo, Japan;Second Department of Surgery, Wakayama Medical University, School of Medicine, Wakayama, Japan;

关键词: Pancreatic ductal carcinoma;    Peritoneal metastasis;    Peritoneal desemination;    Intraperitoneal Paclitaxel;    Randomized phase3 trial;   

DOI  :  10.1186/s13063-022-06049-7

来源: Springer

【 摘 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/).

【 授权许可】

CC BY