title: Preliminary results of Radiation Therapy Oncology Group 97-03: a randomized phase ii trial of concurrent radiation and chemotherapy for advanced squamous cell carcinomas of the head and neck.
abstract: OBJECTIVE
  To define further the role of concurrent chemoradiotherapy for patients with advanced squamous carcinoma of the head and neck.
  
  
  METHODS
  The Radiation Therapy Oncology Group developed this three-arm randomized phase II trial. Patients with stage III or IV squamous carcinoma of the oral cavity, oropharynx, or hypopharynx were eligible. Each of three arms proposed a radiation schedule of 70 Gy in 35 fractions. Patients on arm 1 were to receive cisplatin 10 mg/m(2) daily and fluorouracil (FU) 400 mg/m(2) continuous infusion (CI) daily for the final 10 days of treatment. Treatment on arm 2 consisted of hydroxyurea 1 g every 12 hours and FU 800 mg/m(2)/d CI delivered with each fraction of radiation. Arm 3 patients were to receive weekly paclitaxel 30 mg/m(2) and cisplatin 20 mg/m(2). Patients randomly assigned to arms 1 and 3 were to receive their treatments every week; patients on arm 2 were to receive their therapy every other week.
  
  
  RESULTS
  Between 1997 and 1999, 241 patients were entered onto study; 231 were analyzable. Ninety-two percent, 79%, and 83% of patients on arms 1, 2, and 3, respectively, were able to complete their radiation as planned or with an acceptable variation. Fewer than 10% of patients had unacceptable deviations or incomplete chemotherapy in the three arms. Estimated 2-year disease-free and overall survival rates were 38.2% and 57.4% for arm 1, 48.6% and 69.4% for arm 2, and 51.3% and 66.6% for arm 3.
  
  
  CONCLUSIONS
  We have demonstrated that three different approaches of concurrent multiagent chemotherapy and radiation were feasible and could be delivered to patients in a multi-institutional setting with high compliance rates.
authors.affiliation: Department of Radiation Oncology, Unit 97, University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA. agarden@mdanderson.org
authors.forename: A S
authors.initials: AS
authors.lastname: Garden
authors.forename: J
authors.initials: J
authors.lastname: Harris
authors.forename: E E
authors.initials: EE
authors.lastname: Vokes
authors.forename: A A
authors.initials: AA
authors.lastname: Forastiere
authors.forename: J A
authors.initials: JA
authors.lastname: Ridge
authors.forename: C
authors.initials: C
authors.lastname: Jones
authors.forename: E M
authors.initials: EM
authors.lastname: Horwitz
authors.forename: B S
authors.initials: BS
authors.lastname: Glisson
authors.forename: L
authors.initials: L
authors.lastname: Nabell
authors.forename: J S
authors.initials: JS
authors.lastname: Cooper
authors.forename: W
authors.initials: W
authors.lastname: Demas
authors.forename: E
authors.initials: E
authors.lastname: Gore
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D006801:Humans; D006918:Hydroxyurea / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011879:Radiotherapy Dosage; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel; D002945:Cisplatin; D005472:Fluorouracil; D006918:Hydroxyurea