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01-12-2022 | Metastasis | Study protocol

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)

Authors: 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

Published in: Trials | Issue 1/2022

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/).

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Title: 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)
Authors: 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
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Metastasis
Cytostatic Therapy
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06049-7

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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)

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

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