| アイテムタイプ |
学術雑誌論文 / Journal Article(1) |
| 公開日 |
2025-10-07 |
| タイトル |
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タイトル |
A phase II clinical trial on the efficacy and safety of carboplatin plus nab-paclitaxel in chemotherapy-naive advanced or recurrent thymic epithelial tumors: protocol of Nab-TET |
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言語 |
en |
| 言語 |
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言語 |
eng |
| キーワード |
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言語 |
en |
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主題Scheme |
Other |
|
主題 |
Carboplatin |
| キーワード |
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言語 |
en |
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主題Scheme |
Other |
|
主題 |
chemotherapy |
| キーワード |
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言語 |
en |
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主題Scheme |
Other |
|
主題 |
clinical trial |
| キーワード |
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言語 |
en |
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主題Scheme |
Other |
|
主題 |
nab-paclitaxel |
| キーワード |
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|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
thymic epithelial tumor (TET) |
| 資源タイプ |
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|
資源タイプ識別子 |
http://purl.org/coar/resource_type/c_6501 |
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資源タイプ |
journal article |
| 著者 |
Hayashi, Fumiko
Matsuo, Midori
Takemoto, Shinnosuke
Ogata, Ryosuke
Umeyama, Yasuhiro
Nakatomi, Katsumi
Ikeda, Takaya
Sugasaki Nanae
Doi, Seiji
Kitazaki, Takeshi
Akagi, Kazumasa
Tomono, Hiromi
Honda, Noritaka
Dotsu, Yosuke
Taniguchi, Hirokazu
Gyotoku, Hiroshi
Fukuda, Minoru
Soda, Hiroshi
Mukae, Hiroshi
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| 抄録 |
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内容記述タイプ |
Abstract |
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内容記述 |
Background: Thymic epithelial tumors (TETs) are rare, posing challenges for conducting large-scale clinical trials and leading to slower therapeutic advancements compared with other cancers. Although carboplatin plus paclitaxel therapy is the preferred standard treatment, its clinical use presents challenges, including the frequent occurrence of peripheral neuropathy. In a phase III study, carboplatin plus nab-paclitaxel therapy demonstrated superior efficacy over carboplatin plus paclitaxel therapy in advanced or recurrent non-small cell lung cancer, with reduced adverse events such as peripheral neuropathy, neutropenia, and myalgia. Carboplatin plus nab-paclitaxel therapy has the potential to offer similar efficacy with reduced toxicity in TETs. Therefore, we plan to conduct a phase II clinical trial to clarify the efficacy and safety of carboplatin plus nab-paclitaxel in patients with TETs. Methods: This study plans to enroll 44 patients with advanced or recurrent TETs, with a performance status of 0 or 1, and adequate organ function. Carboplatin (area under the blood concentration-time curve of 5 or 6) will be administered on day 1, while nab-paclitaxel (100 mg/m2) will be administered on days 1, 8, and 15 intravenously every 3 weeks for four cycles. The primary endpoint is overall response rate, and the secondary endpoints are overall survival, progression-free survival, incidence rate of adverse events, and quality of life. Discussion: Carboplatin plus nab-paclitaxel therapy may serve as a promising first-line regimen with a relatively mild side-effect profile and expected efficacy in rare TETs. We aim to determine whether this therapy is a better treatment option with lower toxicity. Trial Registration: This clinical trial was registered in the Japan Registry of Clinical Trials (No. jRCTs071240019) on June 6th, 2024. |
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言語 |
en |
| 書誌情報 |
en : Journal of Thoracic Disease
巻 17,
号 9,
p. 7343-7351,
発行日 2025-09-25
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| 出版者 |
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出版者 |
AME Publishing Company |
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言語 |
en |
| ISSN |
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収録物識別子タイプ |
ISSN |
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収録物識別子 |
20721439 |
| DOI |
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関連タイプ |
isIdenticalTo |
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識別子タイプ |
DOI |
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関連識別子 |
https://doi.org/10.21037/jtd-2025-1110 |
| 権利 |
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権利情報 |
© 2025 AME Publishing Company. All rights reserved. This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non- commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd. |
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言語 |
en |
| 著者版フラグ |
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出版タイプ |
VoR |
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出版タイプResource |
http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| 引用 |
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内容記述タイプ |
Other |
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内容記述 |
Journal of Thoracic Disease, 17(9), pp.7343-7351; 2025 |
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言語 |
en |
JTD17_7343.pdf (283 KB)
