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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
https://doi.org/10.18999/nagjms.81.2.233
https://doi.org/10.18999/nagjms.81.2.233c90599b4-a084-43f1-811a-aa5e87d249d1
| 名前 / ファイル | ライセンス | アクション |
|---|---|---|
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
× 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 |
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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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| 著者版フラグ | ||||||
| 値 | publisher | |||||
