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Phase II study of chemoradiotherapy combined with gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic ductal adenocarcinoma (NUPAT 05 Trial): study protocol for a single arm phase II study

The efficacy of nab-paclitaxel combined with gemcitabine (GnP) and of chemoradiotherapy (CRT) for unresectable locally advanced pancreatic ductal adenocarcinoma (UR-LA PDAC) is still unclear. We previously conducted a phase I study of CRT using GnP and determined the recommended dose and have now de...

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Autores principales: Takano, Nao, Yamada, Suguru, Hirakawa, Akihiro, Yokoyama, Yukihiro, Kawashima, Hiroki, Maeda, Osamu, Okada, Tohru, Ohno, Eizaburo, Yamaguchi, Junpei, Ishikawa, Takuya, Sonohara, Fuminori, Suenaga, Masaya, Takami, Hideki, Hayashi, Masamichi, Niwa, Yukiko, Hirooka, Yoshiki, Ito, Yoshiyuki, Naganawa, Shinji, Ando, Yuichi, Nagino, Masato, Goto, Hidemi, Fujii, Tsutomu, Kodera, Yasuhiro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nagoya University 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6556455/
https://www.ncbi.nlm.nih.gov/pubmed/31239592
http://dx.doi.org/10.18999/nagjms.81.2.233
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author Takano, Nao
Yamada, Suguru
Hirakawa, Akihiro
Yokoyama, Yukihiro
Kawashima, Hiroki
Maeda, Osamu
Okada, Tohru
Ohno, Eizaburo
Yamaguchi, Junpei
Ishikawa, Takuya
Sonohara, Fuminori
Suenaga, Masaya
Takami, Hideki
Hayashi, Masamichi
Niwa, Yukiko
Hirooka, Yoshiki
Ito, Yoshiyuki
Naganawa, Shinji
Ando, Yuichi
Nagino, Masato
Goto, Hidemi
Fujii, Tsutomu
Kodera, Yasuhiro
author_facet Takano, Nao
Yamada, Suguru
Hirakawa, Akihiro
Yokoyama, Yukihiro
Kawashima, Hiroki
Maeda, Osamu
Okada, Tohru
Ohno, Eizaburo
Yamaguchi, Junpei
Ishikawa, Takuya
Sonohara, Fuminori
Suenaga, Masaya
Takami, Hideki
Hayashi, Masamichi
Niwa, Yukiko
Hirooka, Yoshiki
Ito, Yoshiyuki
Naganawa, Shinji
Ando, Yuichi
Nagino, Masato
Goto, Hidemi
Fujii, Tsutomu
Kodera, Yasuhiro
author_sort Takano, Nao
collection PubMed
description The efficacy of nab-paclitaxel combined with gemcitabine (GnP) and of chemoradiotherapy (CRT) for unresectable locally advanced pancreatic ductal adenocarcinoma (UR-LA PDAC) is still unclear. We previously conducted a phase I study of CRT using GnP and determined the recommended dose and have now designed a phase II trial to evaluate the efficacy of CRT incorporating GnP for UR-LA PDAC. Eligibility criteria are chemotherapy-naïve patients with UR-LA PDAC as defined by the NCCN guidelines version 2. 2016. Study patients will receive 100 mg/m(2) nab-paclitaxel and 800 mg/m(2) gemcitabine on Days 1, 8, and 15 per 4-week cycle with concurrent radiation therapy (total dose of 50.4 Gy in 28 fractions of 1.8 Gy per day, 5 days per week). Treatment will be continued until disease progression or surgery, which is to be performed only for patients in whom the disease is well-controlled at 8 months from beginning the protocol treatment. Primary endpoint is 2-year overall survival rate and co-primary endpoint is resection rate. Secondary endpoints are overall survival, progression free survival, time to treatment failure, response rate, disease control rate, early tumor shrinkage, depth of response, reduction of SUV-max on PET–CT, serum tumor markers, relative dose intensity, safety, and Quality of life. This study will show the efficacy and safety of chemoradiotherapy combined with GnP.
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spelling pubmed-65564552019-06-25 Phase II study of chemoradiotherapy combined with gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic ductal adenocarcinoma (NUPAT 05 Trial): study protocol for a single arm phase II study Takano, Nao Yamada, Suguru Hirakawa, Akihiro Yokoyama, Yukihiro Kawashima, Hiroki Maeda, Osamu Okada, Tohru Ohno, Eizaburo Yamaguchi, Junpei Ishikawa, Takuya Sonohara, Fuminori Suenaga, Masaya Takami, Hideki Hayashi, Masamichi Niwa, Yukiko Hirooka, Yoshiki Ito, Yoshiyuki Naganawa, Shinji Ando, Yuichi Nagino, Masato Goto, Hidemi Fujii, Tsutomu Kodera, Yasuhiro Nagoya J Med Sci Original Paper The efficacy of nab-paclitaxel combined with gemcitabine (GnP) and of chemoradiotherapy (CRT) for unresectable locally advanced pancreatic ductal adenocarcinoma (UR-LA PDAC) is still unclear. We previously conducted a phase I study of CRT using GnP and determined the recommended dose and have now designed a phase II trial to evaluate the efficacy of CRT incorporating GnP for UR-LA PDAC. Eligibility criteria are chemotherapy-naïve patients with UR-LA PDAC as defined by the NCCN guidelines version 2. 2016. Study patients will receive 100 mg/m(2) nab-paclitaxel and 800 mg/m(2) gemcitabine on Days 1, 8, and 15 per 4-week cycle with concurrent radiation therapy (total dose of 50.4 Gy in 28 fractions of 1.8 Gy per day, 5 days per week). Treatment will be continued until disease progression or surgery, which is to be performed only for patients in whom the disease is well-controlled at 8 months from beginning the protocol treatment. Primary endpoint is 2-year overall survival rate and co-primary endpoint is resection rate. Secondary endpoints are overall survival, progression free survival, time to treatment failure, response rate, disease control rate, early tumor shrinkage, depth of response, reduction of SUV-max on PET–CT, serum tumor markers, relative dose intensity, safety, and Quality of life. This study will show the efficacy and safety of chemoradiotherapy combined with GnP. Nagoya University 2019-05 /pmc/articles/PMC6556455/ /pubmed/31239592 http://dx.doi.org/10.18999/nagjms.81.2.233 Text en http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. To view the details of this license, please visit (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Original Paper
Takano, Nao
Yamada, Suguru
Hirakawa, Akihiro
Yokoyama, Yukihiro
Kawashima, Hiroki
Maeda, Osamu
Okada, Tohru
Ohno, Eizaburo
Yamaguchi, Junpei
Ishikawa, Takuya
Sonohara, Fuminori
Suenaga, Masaya
Takami, Hideki
Hayashi, Masamichi
Niwa, Yukiko
Hirooka, Yoshiki
Ito, Yoshiyuki
Naganawa, Shinji
Ando, Yuichi
Nagino, Masato
Goto, Hidemi
Fujii, Tsutomu
Kodera, Yasuhiro
Phase II study of chemoradiotherapy combined with gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic ductal adenocarcinoma (NUPAT 05 Trial): study protocol for a single arm phase II study
title Phase II study of chemoradiotherapy combined with gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic ductal adenocarcinoma (NUPAT 05 Trial): study protocol for a single arm phase II study
title_full Phase II study of chemoradiotherapy combined with gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic ductal adenocarcinoma (NUPAT 05 Trial): study protocol for a single arm phase II study
title_fullStr Phase II study of chemoradiotherapy combined with gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic ductal adenocarcinoma (NUPAT 05 Trial): study protocol for a single arm phase II study
title_full_unstemmed Phase II study of chemoradiotherapy combined with gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic ductal adenocarcinoma (NUPAT 05 Trial): study protocol for a single arm phase II study
title_short Phase II study of chemoradiotherapy combined with gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic ductal adenocarcinoma (NUPAT 05 Trial): study protocol for a single arm phase II study
title_sort phase ii study of chemoradiotherapy combined with gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic ductal adenocarcinoma (nupat 05 trial): study protocol for a single arm phase ii study
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6556455/
https://www.ncbi.nlm.nih.gov/pubmed/31239592
http://dx.doi.org/10.18999/nagjms.81.2.233
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