A Comparison of Multimodality Treatment: Two and Four Courses of Neoadjuvant Chemotherapy Using S-1/CDDP or S-1/CDDP/Docetaxel Followed by Surgery and S-1 Adjuvant Chemotherapy for Macroscopically Resectable Serosa-positive Gastric Cancer: A Randomized Phase II Trial (COMPASS-D Trial)

被引:14
作者
Yoshikawa, Takaki [1 ]
Taguri, Masataka [2 ]
Sakuramoto, Shinichi [3 ]
Kunisaki, Chikara [4 ]
Fukunaga, Tetsu [5 ]
Ito, Seiji [6 ]
Cho, Haruhiko
Tanabe, Kazuaki [7 ]
Nishikawa, Kazuhiro [8 ]
Matsui, Takanori [9 ]
Morita, Satoshi [2 ]
Tsuburaya, Akira
机构
[1] Kanagawa Canc Ctr, Dept Gastrointestinal Surg, Asahi Ku, Yokohama, Kanagawa 2410815, Japan
[2] Yokohama City Univ, Med Ctr, Dept Biostat & Epidemiol, Yokohama, Kanagawa 232, Japan
[3] Kitasato Univ, Dept Surg, Sagamihara, Kanagawa 228, Japan
[4] Yokohama City Univ, Med Ctr, Dept Surg, Yokohama, Kanagawa 232, Japan
[5] St Marianna Univ, Dept Gastroenterol & Gen Surg, Kawasaki, Kanagawa, Japan
[6] Aichi Canc Ctr Hosp, Dept Surg Gastroenterol, Nagoya, Aichi 464, Japan
[7] Hiroshima Univ, Dept Gastrointestinal Surg, Hiroshima, Japan
[8] Osaka Gen Med Ctr, Dept Surg, Osaka, Japan
[9] Aichi Hosp, Aichi Canc Ctr, Dept Gastrointestinal Surg, Okazaki, Aichi, Japan
关键词
gastric; neoadjuvant chemotherapy; Phase II; cancer; PLUS CISPLATIN; PERIOPERATIVE CHEMOTHERAPY; PACLITAXEL; MULTICENTER; ADENOCARCINOMA; THERAPY;
D O I
10.1093/jjco/hyr166
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
This randomized Phase II trial will compare the outcome of neoadjuvant chemotherapy using two and four courses of S-1 plus cisplatin or S-1 plus cisplatin plus docetaxel by a two-by-two factorial design for patients with macroscopically resectable serosa-positive gastric cancer. After neoadjuvant chemotherapy, patients will receive D2 gastrectomy followed by S-1 chemotherapy for 1 year postoperatively. The primary endpoint is the 3-year overall survival. The sample size is 120 for the two hypotheses: the superiority of four courses compared with two courses and the superiority of S-1 plus cisplatin plus docetaxel compared with S-1 plus cisplatin. This trial will be able to define the more suitable number of cycles and better regimen of neoadjuvant chemotherapy for gastric cancer.
引用
收藏
页码:74 / 77
页数:4
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