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Neoadjuvant Chemotherapy with Gemcitabine Plus Nab-Paclitaxel Regimen for Borderline Resectable Pancreatic Cancer with Arterial Involvement: A Prospective Multicenter Single-Arm Phase II Study Protocol
INTRODUCTION: Although neoadjuvant treatment is recommended for patients with borderline resectable pancreatic cancer (BRPC), no standard neoadjuvant regimen has been established for BRPC with arterial involvement (BRPC-A), which is associated with a higher risk of margin-positive resection and poor...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
IJS Publishing Group
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8114838/ https://www.ncbi.nlm.nih.gov/pubmed/34013145 http://dx.doi.org/10.29337/ijsp.142 |
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author | Miyasaka, Yoshihiro Ohtsuka, Takao Eguchi, Susumu Inomata, Masafumi Nishihara, Kazuyoshi Shinchi, Hiroyuki Okuda, Koji Baba, Hideo Nagano, Hiroaki Ueki, Toshiharu Noshiro, Hirokazu Nakamura, Masafumi |
author_facet | Miyasaka, Yoshihiro Ohtsuka, Takao Eguchi, Susumu Inomata, Masafumi Nishihara, Kazuyoshi Shinchi, Hiroyuki Okuda, Koji Baba, Hideo Nagano, Hiroaki Ueki, Toshiharu Noshiro, Hirokazu Nakamura, Masafumi |
author_sort | Miyasaka, Yoshihiro |
collection | PubMed |
description | INTRODUCTION: Although neoadjuvant treatment is recommended for patients with borderline resectable pancreatic cancer (BRPC), no standard neoadjuvant regimen has been established for BRPC with arterial involvement (BRPC-A), which is associated with a higher risk of margin-positive resection and poorer prognosis than BRPC with only venous involvement. Gemcitabine plus nab-paclitaxel (GnP) has been reported to significantly reduce tumor size in metastatic pancreatic cancer, and some retrospective studies suggested that neoadjuvant GnP for BRPC improved resectability and survival. METHODS AND ANALYSIS: A prospective multicenter single-arm phase II study is conducted to evaluate the safety and efficacy of GnP as neoadjuvant chemotherapy for BRPC-A. The primary endpoint is the R0 resection rate. The secondary endpoints are the neoadjuvant chemotherapy response rate, resection rate, pathological response rate, incidence rate of adverse events, and quality of life. ETHICS AND DISSEMINATION: This study protocol was approved by the institutional review board of Kyushu University (no. 181). The results will be published in a peer-reviewed journal and will be presented at medical meetings. HIGHLIGHTS: Strategy for borderline resectable pancreatic cancer involving arteries (BRPC-A). There is no standard regimen for neoadjuvant chemotherapy for BRPC-A. Gemcitabine plus nab-paclitaxel (GnP) shows significant tumor shrinkage. Neoadjuvant GnP for BRPC-A increases resectability and margin-negative resection. |
format | Online Article Text |
id | pubmed-8114838 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | IJS Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-81148382021-05-18 Neoadjuvant Chemotherapy with Gemcitabine Plus Nab-Paclitaxel Regimen for Borderline Resectable Pancreatic Cancer with Arterial Involvement: A Prospective Multicenter Single-Arm Phase II Study Protocol Miyasaka, Yoshihiro Ohtsuka, Takao Eguchi, Susumu Inomata, Masafumi Nishihara, Kazuyoshi Shinchi, Hiroyuki Okuda, Koji Baba, Hideo Nagano, Hiroaki Ueki, Toshiharu Noshiro, Hirokazu Nakamura, Masafumi Int J Surg Protoc Protocol INTRODUCTION: Although neoadjuvant treatment is recommended for patients with borderline resectable pancreatic cancer (BRPC), no standard neoadjuvant regimen has been established for BRPC with arterial involvement (BRPC-A), which is associated with a higher risk of margin-positive resection and poorer prognosis than BRPC with only venous involvement. Gemcitabine plus nab-paclitaxel (GnP) has been reported to significantly reduce tumor size in metastatic pancreatic cancer, and some retrospective studies suggested that neoadjuvant GnP for BRPC improved resectability and survival. METHODS AND ANALYSIS: A prospective multicenter single-arm phase II study is conducted to evaluate the safety and efficacy of GnP as neoadjuvant chemotherapy for BRPC-A. The primary endpoint is the R0 resection rate. The secondary endpoints are the neoadjuvant chemotherapy response rate, resection rate, pathological response rate, incidence rate of adverse events, and quality of life. ETHICS AND DISSEMINATION: This study protocol was approved by the institutional review board of Kyushu University (no. 181). The results will be published in a peer-reviewed journal and will be presented at medical meetings. HIGHLIGHTS: Strategy for borderline resectable pancreatic cancer involving arteries (BRPC-A). There is no standard regimen for neoadjuvant chemotherapy for BRPC-A. Gemcitabine plus nab-paclitaxel (GnP) shows significant tumor shrinkage. Neoadjuvant GnP for BRPC-A increases resectability and margin-negative resection. IJS Publishing Group 2021-04-26 /pmc/articles/PMC8114838/ /pubmed/34013145 http://dx.doi.org/10.29337/ijsp.142 Text en Copyright: © 2021 The Author(s) https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License (CC-BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. See http://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Protocol Miyasaka, Yoshihiro Ohtsuka, Takao Eguchi, Susumu Inomata, Masafumi Nishihara, Kazuyoshi Shinchi, Hiroyuki Okuda, Koji Baba, Hideo Nagano, Hiroaki Ueki, Toshiharu Noshiro, Hirokazu Nakamura, Masafumi Neoadjuvant Chemotherapy with Gemcitabine Plus Nab-Paclitaxel Regimen for Borderline Resectable Pancreatic Cancer with Arterial Involvement: A Prospective Multicenter Single-Arm Phase II Study Protocol |
title | Neoadjuvant Chemotherapy with Gemcitabine Plus Nab-Paclitaxel Regimen for Borderline Resectable Pancreatic Cancer with Arterial Involvement: A Prospective Multicenter Single-Arm Phase II Study Protocol |
title_full | Neoadjuvant Chemotherapy with Gemcitabine Plus Nab-Paclitaxel Regimen for Borderline Resectable Pancreatic Cancer with Arterial Involvement: A Prospective Multicenter Single-Arm Phase II Study Protocol |
title_fullStr | Neoadjuvant Chemotherapy with Gemcitabine Plus Nab-Paclitaxel Regimen for Borderline Resectable Pancreatic Cancer with Arterial Involvement: A Prospective Multicenter Single-Arm Phase II Study Protocol |
title_full_unstemmed | Neoadjuvant Chemotherapy with Gemcitabine Plus Nab-Paclitaxel Regimen for Borderline Resectable Pancreatic Cancer with Arterial Involvement: A Prospective Multicenter Single-Arm Phase II Study Protocol |
title_short | Neoadjuvant Chemotherapy with Gemcitabine Plus Nab-Paclitaxel Regimen for Borderline Resectable Pancreatic Cancer with Arterial Involvement: A Prospective Multicenter Single-Arm Phase II Study Protocol |
title_sort | neoadjuvant chemotherapy with gemcitabine plus nab-paclitaxel regimen for borderline resectable pancreatic cancer with arterial involvement: a prospective multicenter single-arm phase ii study protocol |
topic | Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8114838/ https://www.ncbi.nlm.nih.gov/pubmed/34013145 http://dx.doi.org/10.29337/ijsp.142 |
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