title: A Phase I/II trial of radiotherapy concurrent with TS-1 plus cisplatin in patients with clinically resectable type 4 or large type 3 gastric cancer: Osaka Gastrointestinal Cancer Chemotherapy Study Group OGSG1205.
abstract: A Phase I/II trial of radiotherapy administered concurrently with TS-1 plus cisplatin has been initiated in Japanese patients with clinical resectable type 4 or large type 3 gastric cancer. The aim of this trial is to determine the recommended dose of TS-1 and cisplatin combined with radiotherapy at a fixed dose in the Phase I study, and to evaluate the efficacy and safety in the Phase II study. The primary endpoint for Phase II is the pathological complete response rate, assessed using surgically resected specimens. Secondary endpoints are the response rate, progression-free survival, overall survival, operation transitional rate, R0 resection rate, rate of treatment completion, rate of down-staging and rates of postoperative complications and adverse events. In Phase II, a total of 30 patients will be enrolled in the Osaka Gastrointestinal Cancer Chemotherapy Study Group trial over a period of 6 years.
authors: Department of Surgery, Kinki University Faculty of Medicine, Osaka-Sayama, Osaka, Japan. imano@med.kindai.ac.jp
authors: Motohiro
authors: M
authors: Imano
authors: Hiroshi
authors: H
authors: Furukawa
authors: Masaki
authors: M
authors: Yokokawa
authors: Yasumasa
authors: Y
authors: Nishimura
authors: Yukinori
authors: Y
authors: Kurokawa
authors: Taroh
authors: T
authors: Satoh
authors: Daisuke
authors: D
authors: Sakai
authors: Takushi
authors: T
authors: Yasuda
authors: Haruhiko
authors: H
authors: Imamoto
authors: Toshimasa
authors: T
authors: Tujinaka
authors: Toshio
authors: T
authors: Shimokawa
authors: Hitoshi
authors: H
authors: Shiozaki
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D006801:Humans; D011183:Postoperative Complications; D017640:Silicates / Q000008:administration & dosage; D013274:Stomach Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D014025:Titanium / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D017640:Silicates; C103828:titanium silicide; D014025:Titanium; D002945:Cisplatin