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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)
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 meta...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8817533/ https://www.ncbi.nlm.nih.gov/pubmed/35123553 http://dx.doi.org/10.1186/s13063-022-06049-7 |
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author | 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 |
author_facet | 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 |
author_sort | Yamamoto, Tomohisa |
collection | PubMed |
description | 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/). |
format | Online Article Text |
id | pubmed-8817533 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-88175332022-02-07 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) 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 Trials Study Protocol 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/). BioMed Central 2022-02-05 /pmc/articles/PMC8817533/ /pubmed/35123553 http://dx.doi.org/10.1186/s13063-022-06049-7 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol 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 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) |
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) |
title_full | 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) |
title_fullStr | 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) |
title_full_unstemmed | 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) |
title_short | 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) |
title_sort | 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) |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8817533/ https://www.ncbi.nlm.nih.gov/pubmed/35123553 http://dx.doi.org/10.1186/s13063-022-06049-7 |
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