title: Phase I study of neoadjuvant chemoradiotherapy consisting of S-1 and cisplatin for patients with resectable advanced gastric cancer (KOGC-01).
abstract: BACKGROUND
  The prognosis for advanced gastric cancer is poor, with surgery as the only treatment for resectable advanced gastric cancer. Therefore, treatment options that might improve the prognosis are needed. To that end, neoadjuvant chemoradiotherapy with S-1 and cisplatin (CDDP) was investigated.
  
  
  METHODS
  The chemotherapy schedule included one cycle repeated after 6 weeks. S-1 was administered orally every day on days 1-21 and CDDP was infused on days 1, 8 and 15. Radiation therapy was started concurrently with chemotherapy and repeated daily on days 1-5, 8-12, 15-19, and 22-26.
  
  
  RESULTS
  A total of 10 patients were recruited. The first four patients were entered into level 1 (CDDP, 20 mg/m²). The next six patients were entered into level 0 (15 mg/m²), because of dose-limiting toxicity (delaying the second course of chemotherapy in two patients) that had been observed at level 1. The maximum tolerated dose (MTD) of CDDP was 20 mg/m². Seven patients underwent surgery and all had an R0 (no residual tumor) resection without surgical complications.
  
  
  CONCLUSIONS
  Neoadjuvant chemoradiotherapy with S-1 and CDDP may cause surgery to be delayed, but shows promise for resectable advanced gastric cancer.
authors.affiliation: Keio Cancer Center, School of Medicine, Keio University, Shinjuku, Tokyo, Japan.
authors.forename: Tsunehiro
authors.initials: T
authors.lastname: Takahashi
authors.forename: Yoshiro
authors.initials: Y
authors.lastname: Saikawa
authors.forename: Hiromasa
authors.initials: H
authors.lastname: Takaishi
authors.forename: Hiroya
authors.initials: H
authors.lastname: Takeuchi
authors.forename: Norihito
authors.initials: N
authors.lastname: Wada
authors.forename: Takashi
authors.initials: T
authors.lastname: Oyama
authors.forename: Kazumasa
authors.initials: K
authors.lastname: Fukuda
authors.forename: Junichi
authors.initials: J
authors.lastname: Fukada
authors.forename: Osamu
authors.initials: O
authors.lastname: Kawaguchi
authors.forename: Naoyuki
authors.initials: N
authors.lastname: Shigematsu
authors.forename: Yuko
authors.initials: Y
authors.lastname: Kitagawa
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage; D013274:Stomach Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D005641:Tegafur / Q000008:administration & dosage
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin