title: A phase I trial of 5-fluorouracil with cisplatin and concurrent standard-dose radiotherapy in Japanese patients with stage II/III esophageal cancer.
abstract: OBJECTIVE
  In Japan, 5-fluorouracil (5-FU) 400 mg/m(2) on Days 1-5, 8-12, 36-40 and 43-46 with cisplatin (CDDP) 40 mg/m(2) on Days 1, 8, 36 and 43 plus concurrent radiotherapy with 2 weeks planned interruption (60 Gy) was standard for the patients with esophageal cancer. This Phase I trial was designed to determine the maximal tolerated dose (MTD) and dose-limiting toxicity (DLT) of 5-FU on Days 1-4 and 29-32 with CDDP on Days 1 and 29 plus concurrent radiotherapy (50.4 Gy) among the Japanese.
  
  
  METHODS
  Escalating doses of 5-FU and CDDP were administered with concurrent radiotherapy (50.4 Gy). Treatment was continued until DLT appeared.
  
  
  RESULTS
  Twelve patients with previously untreated clinical Stage II/III squamous cell esophageal carcinoma were studied. One of six patients given Level 1 (5-FU 800 mg/m(2) on Days 1-4 and 29-32 with CDDP 75 mg/m(2) on Days 1 and 29) developed a DLT of incomplete protocol treatment due to Grade 3 esophagitis. The MTD was not reached at Level 2 (5-FU 1000 mg/m(2) with CDDP 75 mg/m(2)). The complete response rate was 67% at Level 1 and 100% at Level 2.
  
  
  CONCLUSIONS
  Dose Level 2 with 50.4 Gy radiotherapy was recommended for Japanese patients.
authors.affiliation: Gastrointestinal Oncology Division, National Cancer Center Hospital, Tokyo, Japan. taeguchi@ncc.go.jp
authors.forename: Takako Eguchi
authors.initials: TE
authors.lastname: Nakajima
authors.forename: Takashi
authors.initials: T
authors.lastname: Ura
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Ito
authors.forename: Ken
authors.initials: K
authors.lastname: Kato
authors.forename: Keiko
authors.initials: K
authors.lastname: Minashi
authors.forename: Keiji
authors.initials: K
authors.lastname: Nihei
authors.forename: Shuichi
authors.initials: S
authors.lastname: Hironaka
authors.forename: Narikazu
authors.initials: N
authors.lastname: Boku
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Kagami
authors.forename: Kei
authors.initials: K
authors.lastname: Muro
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000532:radiotherapy / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018196:Carcinoma, Adenosquamous / Q000188:drug therapy / Q000532:radiotherapy / Q000556:secondary; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000532:radiotherapy / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004307:Dose-Response Relationship, Radiation; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging
chemical_list: D002945:Cisplatin; D005472:Fluorouracil