| JaLCDOI | 10.18926/AMO/54607 |
|---|---|
| フルテキストURL | 70_5_425.pdf |
| 著者 | Tamura, Tomoki| Hirata, Taizo| Tabata, Masahiro| Hinotsu, Shiro| Hamada, Akinobu| Motoki, Takayuki| Iwamoto, Takayuki| Mizoo, Taeko| Nogami, Tomohiro| Shien, Tadahiko| Taira, Naruto| Matsuoka, Junji| Doihara, Hiroyoshi| |
| 抄録 | Docetaxel is a standard treatment for patients with advanced or recurrent breast cancer. The recommended dose is 60 to 100 mg/m2. Previous study have shown that the tumor response rates of patients who received docetaxel monotherapy at doses of 60, 75, and 100 mg/m2 were 22.1% , 23.3% , and 36.0% , respectively, and there was a significant relationship between the dose and response. In Europe and the United States, docetaxel is approved at a dose of 100 mg/m2, and Japanese guidelines also recommend a dose of 100 mg/m2. However, the approved dose in Japan is up to 75 mg/m2. We have launched a phase I trial evaluating 100 mg/m2 docetaxel in patients with advanced or relapsed breast cancer. The major eligibility criteria are as follows: age ≥20 years, pathologically diagnosed breast cancer, recurrent or advanced breast cancer, a good performance status, and HER2 [human epidermal growth factor receptor 2] negative. The primary endpoint is demonstrated safety of 100 mg/m2 docetaxel. This study will clarify whether 100mg/m2 docetaxel can be administrated safely in Japanese patients with advanced or recurrent breast cancer. |
| キーワード | breast cancer phase I trial docetaxel |
| Amo Type | Clinical Study Protocols |
| 発行日 | 2016-10 |
| 出版物タイトル | Acta Medica Okayama |
| 巻 | 70巻 |
| 号 | 5号 |
| 出版者 | Okayama University Medical School |
| 開始ページ | 425 |
| 終了ページ | 427 |
| ISSN | 0386-300X |
| NCID | AA00508441 |
| 資料タイプ | 学術雑誌論文 |
| 言語 | English |
| 著作権者 | CopyrightⒸ 2016 by Okayama University Medical School |
| 論文のバージョン | publisher |
| 査読 | 有り |
| PubMed ID | 27777441 |
| Web of Science KeyUT | 000388098700018 |
| JaLCDOI | 10.18926/AMO/54601 |
|---|---|
| フルテキストURL | 70_5_401.pdf |
| 著者 | Kuroda, Shinji| Kikuchi, Satoru| Nishizaki, Masahiko| Kagawa, Shunsuke| Hinotsu, Shiro| Fujiwara, Toshiyoshi| |
| 抄録 | Although intermittent pneumatic compression (IPC) has become common as perioperative prophylaxis for venous thromboembolism (VTE) consisting of pulmonary thromboembolism (PE) and deep vein thrombosis (DVT), the prophylactic effect against VTE, especially lethal PE, is not yet satisfactory. Therefore, pharmacologic prophylaxis, such as with enoxaparin, is desirable. While the efficacy and safety of enoxaparin have been proven in several clinical trials, concern about bleeding with longterm (at least 7 days) use have potentially decreased its widespread adoption. We have launched a phase II study to evaluate the efficacy and safety of short-term (3 days) enoxaparin, in which a total of 70 gastric cancer patients undergoing gastrectomy will be recruited, and the primary endpoint is the incidence of DVT. This study could contribute to making pharmacologic prophylaxis for VTE more common. |
| キーワード | venous thromboembolism enoxaparin short-term use gastric cancer surgery |
| Amo Type | Clinical Study Protocols |
| 発行日 | 2016-10 |
| 出版物タイトル | Acta Medica Okayama |
| 巻 | 70巻 |
| 号 | 5号 |
| 出版者 | Okayama University Medical School |
| 開始ページ | 401 |
| 終了ページ | 404 |
| ISSN | 0386-300X |
| NCID | AA00508441 |
| 資料タイプ | 学術雑誌論文 |
| 言語 | English |
| 著作権者 | CopyrightⒸ 2016 by Okayama University Medical School |
| 論文のバージョン | publisher |
| 査読 | 有り |
| PubMed ID | 27777435 |
| Web of Science KeyUT | 000388098700012 |
| タイトル（別表記） | Data management in clinical research |
|---|---|
| 著者 | 樋之津 史郎| |
| キーワード | 臨床研究 倫理指針 ICH-GCP |
| 出版物タイトル | 岡山医学会雑誌 |
| 発行日 | 2017-08-01 |
| 巻 | 129巻 |
| 号 | 2号 |
| 開始ページ | 123 |
| 終了ページ | 127 |
| ISSN | 0030-1558 |
| 関連URL | https://doi.org/10.4044/joma.129.123 |
| 言語 | Japanese |
| 著作権者 | Copyright (c) 2017 岡山医学会 |
| 論文のバージョン | publisher |
| DOI | 10.4044/joma.129.123 |
| JaLCDOI | 10.18926/AMO/54514 |
|---|---|
| フルテキストURL | 70_4_327.pdf |
| 著者 | Watanabe, Mototsugu| Yamamoto, Hiromasa| Eikawa, Shingo| Shien, Kazuhiko| Shien, Tadahiko| Soh, Junichi| Hotta, Katsuyuki| Wada, Jun| Hinotsu, Shiro| Fujiwara, Toshiyoshi| Kiura, Katsuyuki| Doihara, Hiroyoshi| Miyoshi, Shinichiro| Udono, Heiichiro| Toyooka, Shinichi| |
| 抄録 | A study to evaluate the effect of metformin on the immune system was commenced in July 2014. Metformin is one of the most commonly prescribed drugs for type 2 diabetes, and previous studies have reported that metformin has an anti-tumor effect. The aim of this study is to evaluate the efficacy of metformin on the immune system in human cancer patients in vivo. The primary outcome parameter will be the rate change in the population of CD8＋ T cells, which produce multiple cytokines. |
| キーワード | metformin CD8＋ T cells cancer immunology |
| Amo Type | Clinical Study Protocols |
| 発行日 | 2016-08 |
| 出版物タイトル | Acta Medica Okayama |
| 巻 | 70巻 |
| 号 | 4号 |
| 出版者 | Okayama University Medical School |
| 開始ページ | 327 |
| 終了ページ | 330 |
| ISSN | 0386-300X |
| NCID | AA00508441 |
| 資料タイプ | 学術雑誌論文 |
| 言語 | English |
| 著作権者 | CopyrightⒸ 2016 by Okayama University Medical School |
| 論文のバージョン | publisher |
| 査読 | 有り |
| PubMed ID | 27549683 |
| Web of Science KeyUT | 000384748600018 |