title: Phase I Study of Docetaxel, Cisplatin, and 5-Fluorouracil Chemoradiotherapy for Local or Metastatic Esophageal Cancer.
abstract: OBJECTIVE
  Chemoradiotherapy outcomes for unresectable esophageal cancer remain poor. We designed a phase I study of docetaxel, cisplatin (CDDP), and 5-fluorouracil (5-FU) chemoradiotherapy.
  
  
  METHODS
  Patients with T4 or M1 esophageal squamous cell carcinoma were enrolled. They received 2 chemotherapy cycles every 4 weeks with these initial doses (Phase I): docetaxel and CDDP (50 mg/m(2), days 1 and 29) with continuous 5-FU infusion (600 mg/m(2)/day, days 1-5 and 29-33). Concurrent radiotherapy (60 Gy) was initiated on day 1. Docetaxel and CDDP plus 5-FU doses were increased to 60 mg/m(2) plus 800 mg/m(2)/day.
  
  
  RESULTS
  Out of the 15 patients enrolled, 13 completed the treatment. The MTDs were as follows: docetaxel (60 mg/m(2)), CDDP (60 mg/m(2)), and 5-FU (800 mg/m(2)/day). The overall response rate was 73%, with 27% achieving complete responses.
  
  
  CONCLUSIONS
  In this phase I trial, docetaxel (60 mg/m(2)), CDDP (60 mg/m(2)), and 5-FU (600 mg/m(2)/day) were considered as the tolerable and active doses. These are the recommended doses for a future phase II trial.
authors.affiliation: Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University, Tokyo, Japan iwa0715@gmail.com.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Iwasaki
authors.affiliation: Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University, Tokyo, Japan.
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Osaka
authors.affiliation: Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University, Tokyo, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Tachibana
authors.affiliation: Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University, Tokyo, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Suda
authors.affiliation: Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University, Tokyo, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Ota
authors.affiliation: Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University, Tokyo, Japan.
authors.forename: Sumito
authors.initials: S
authors.lastname: Hoshino
authors.affiliation: Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University, Tokyo, Japan.
authors.forename: Akihiko
authors.initials: A
authors.lastname: Tsuchida
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D000077143:Docetaxel; D019583:Dose Fractionation, Radiation; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil
keywords: Esophageal cancer; advanced metastatic disease; chemoradiotherapy; docetaxel