教員業績データベース |
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論文種別 | 原著 |
言語種別 | 英語 |
査読の有無 | 査読あり |
表題 | A randomized Phase II trial of systemic chemotherapy with and without trastuzumab followed by surgery in HER2-positive advanced gastric or esophagogastric junction adenocarcinoma with extensive lymph node metastasis: Japan Clinical Oncology Group study JCOG1301 (Trigger Study). |
掲載誌名 | 正式名:Japanese journal of clinical oncology 略 称:Jpn J Clin Oncol ISSNコード:1465-3621(Electronic)0368-2811(Linking) |
掲載区分 | 国外 |
巻・号・頁 | 45(11),pp.1082-6 |
著者・共著者 | Kataoka Kozo, Tokunaga Masanori, Mizusawa Junki, Machida Nozomu, Katayama Hiroshi, Shitara Kohei, Tomita Toshihiko, Nakamura Kenichi, Boku Narikazu, Sano Takeshi, Terashima Masanori, Sasako Mitsuru |
発行年月 | 2015/11 |
概要 | Pre-operative chemotherapy with S-1 plus cisplatin is considered to be acceptable as one of the standard treatment options for gastric cancer patients with extensive lymph node metastases in Japan. Addition of trastuzumab to chemotherapy is shown to be effective for HER2-positive advanced gastric cancer patients, and we have commenced a randomized Phase II trial in March 2015 to evaluate S-1 plus cisplatin plus trastuzumab compared with S-1 plus cisplatin alone in the neoadjuvant setting for HER2-positive gastric cancer patients with ELM, which are followed by adjuvant chemotherapy with S-1 for 1 year. A total of 130 patients will be accrued from 41 Japanese institutions over 3 years. The primary endpoint is overall survival. The secondary endpoints are progression-free survival, response rate of pre-operative chemotherapy, proportion of patients with R0 resection, proportion of patients who complete the pre-operative chemotherapy and surgery, proportion of patients who complete the protocol treatment including post-operative chemotherapy, pathological response rate and adverse events. This trial has been registered in the UMIN Clinical Trials Registry as UMIN 000016920. |
DOI | 10.1093/jjco/hyv134 |
PMID | 26355164 |