title: 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).
abstract: 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.
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama 241-0815, Japan. yoshikawat@kcch.jp
authors.forename: Takaki
authors.initials: T
authors.lastname: Yoshikawa
authors.forename: Masataka
authors.initials: M
authors.lastname: Taguri
authors.forename: Shinichi
authors.initials: S
authors.lastname: Sakuramoto
authors.forename: Chikara
authors.initials: C
authors.lastname: Kunisaki
authors.forename: Tetsu
authors.initials: T
authors.lastname: Fukunaga
authors.forename: Seiji
authors.initials: S
authors.lastname: Ito
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Cho
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Tanabe
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Nishikawa
authors.forename: Takanori
authors.initials: T
authors.lastname: Matsui
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Akira
authors.initials: A
authors.lastname: Tsuburaya
mesh_terms: D000230:Adenocarcinoma / Q000628:therapy*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D000077143:Docetaxel; D004338:Drug Combinations; D005743:Gastrectomy; D006801:Humans; D020360:Neoadjuvant Therapy; D010094:Oxonic Acid / Q000008:administration & dosage; D013274:Stomach Neoplasms / Q000628:therapy*; D043823:Taxoids / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage
chemical_list: D004338:Drug Combinations; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid; D002945:Cisplatin