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  1. C100 医学部/医学系研究科
  2. C100b 刊行物
  3. Nagoya journal of medical science
  4. 81(2)

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

https://doi.org/10.18999/nagjms.81.2.233
https://doi.org/10.18999/nagjms.81.2.233
c90599b4-a084-43f1-811a-aa5e87d249d1
名前 / ファイル ライセンス アクション
07_Takano.pdf 07_Takano.pdf (233.6 kB)
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Item type 紀要論文 / Departmental Bulletin Paper(1)
公開日 2019-06-13
タイトル
タイトル 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
言語 en
著者 Takano, Nao

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Yamada, Suguru

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Hirakawa, Akihiro

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Yokoyama, Yukihiro

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Kawashima, Hiroki

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Maeda, Osamu

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Okada, Tohru

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Ohno, Eizaburo

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Yamaguchi, Junpei

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Ishikawa, Takuya

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Sonohara, Fuminori

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Suenaga, Masaya

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Takami, Hideki

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Hayashi, Masamichi

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Niwa, Yukiko

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Hirooka, Yoshiki

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Ito, Yoshiyuki

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Naganawa, Shinji

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Ando, Yuichi

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Nagino, Masato

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Goto, Hidemi

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Fujii, Tsutomu

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Kodera, Yasuhiro

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アクセス権
アクセス権 open access
アクセス権URI http://purl.org/coar/access_right/c_abf2
権利
言語 en
権利情報Resource http://creativecommons.org/licenses/by-nc-nd/4.0/
権利情報 Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International
キーワード
主題Scheme Other
主題 II study
キーワード
主題Scheme Other
主題 Gemcitabine
キーワード
主題Scheme Other
主題 nab-paclitaxel
キーワード
主題Scheme Other
主題 chemoradiation
キーワード
主題Scheme Other
主題 unresectable locally advanced pancreatic cancer
抄録
内容記述タイプ Abstract
内容記述 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/m2 nab-paclitaxel and 800 mg/m2 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.
言語 en
出版者
出版者 Nagoya University Graduate School of Medicine, School of Medicine
言語 en
言語
言語 eng
資源タイプ
資源 http://purl.org/coar/resource_type/c_6501
タイプ departmental bulletin paper
出版タイプ
出版タイプ VoR
出版タイプResource http://purl.org/coar/version/c_970fb48d4fbd8a85
ID登録
ID登録 10.18999/nagjms.81.2.233
ID登録タイプ JaLC
関連情報
関連タイプ isVersionOf
識別子タイプ URI
関連識別子 http://www.med.nagoya-u.ac.jp/medlib/nagoya_j_med_sci/812.html
ISSN(print)
収録物識別子タイプ PISSN
収録物識別子 0027-7622
ISSN(Online)
収録物識別子タイプ EISSN
収録物識別子 2186-3326
書誌情報 en : Nagoya Journal of Medical Science

巻 81, 号 2, p. 233-239, 発行日 2019-05
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