神戸大学附属図書館デジタルアーカイブ
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https://hdl.handle.net/20.500.14094/90004551
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2024-04-19
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90004551 (fulltext)
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メタデータID
90004551
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open access
出版タイプ
Version of Record
タイトル
Study protocol of a phase II clinical trial (KSCC1501A) examining oxaliplatin + S-1 for treatment of HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy
著者
Saeki, Hiroshi ; Emi, Yasunori ; Oki, Eiji ; Tokunaga, Shoji ; Kakeji, Yoshihiro ; Akagi, Yoshito ; Baba, Hideo ; Baba, Eishi ; Maehara, Yoshihiko
著者名
Saeki, Hiroshi
著者名
Emi, Yasunori
著者名
Oki, Eiji
著者名
Tokunaga, Shoji
著者ID
A1706
研究者ID
1000080284488
KUID
https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail?systemId=2901d33e92e00ca4520e17560c007669
著者名
Kakeji, Yoshihiro
掛地, 吉弘
カケジ, ヨシヒロ
所属機関名
医学研究科
著者名
Akagi, Yoshito
著者名
Baba, Hideo
著者名
Baba, Eishi
著者名
Maehara, Yoshihiko
収録物名
BMC Cancer
巻(号)
18
ページ
57-57
出版者
BioMed Central
刊行日
2018-01-08
公開日
2018-01-29
抄録
Background: Oxaliplatin + S-1 is a recognized treatment regimen in Japan, but there are no Japanese clinical data on an oxaliplatin dose of 130 mg/m(2). The current research involves a single-arm, prospective, phase II clinical trial to examine the efficacy and safety of oxaliplatin + S-1 with an oxaliplatin dose of 130 mg/m(2) to treat HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy in Japan. Methods/design: The primary endpoint of this trial will be the response rate, and the secondary endpoints will be the safety profile of oxaliplatin + S-1, progression-free survival, the response rate in subjects under the age of 75, overall survival, time to treatment failure, duration of treatment, time to failure of strategy, and dose intensity. The threshold response rate is 45% and the expected response rate is 60%. Assuming that a one-tailed score test will be performed with an α of 0.05, 68 patients are needed to ensure a statistical power of 80%. Planned enrollment is 70 subjects and the total duration of this trial is expected to be 3 years. Discussion: Since replacing cisplatin with oxaliplatin should provide the same level of therapeutic efficacy while limiting adverse events and simplifying treatment, oxaliplatin + S-1 may be increasingly used to treat gastric cancer in Japan. Verifying the efficacy and safety of oxaliplatin + S-1 with an oxaliplatin dose of 130 mg is an important task that the current trial has set out to achieve.
キーワード
Metastatic gastric cancer
First-line chemotherapy
Oxaliplatin
S-1
Japanese patients
カテゴリ
医学研究科
学術雑誌論文
権利
© The Author(s). 2018
This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
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資源タイプ
journal article
言語
English (英語)
eISSN
1471-2407
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関連情報
DOI
https://doi.org/10.1186/s12885-017-3937-6
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