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Garden AS, Harris J, Vokes EE, Forastiere AA, Ridge JA, Jones C, Horwitz EM, Glisson BS, Nabell L, Cooper JS, Demas W, Gore E
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
Journal of Clinical Oncology (2004) 22:2856-2864.
Abstract
PurposeTo define further the role of concurrent chemoradiotherapy for patients with advanced squamous carcinoma of the head and neck.Patients and MethodsThe 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.ResultsBetween 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.ConclusionWe 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. (C) 2004 by American Society of Clinical Oncology. Addresses: Univ Texas, MD Anderson Canc Ctr, Houston, TX 77030 USA; Fox Chase Canc Ctr, Philadelphia, PA 19111 USA; Univ Chicago, Sch Med, Chicago, IL 60637 USA; Johns Hopkins Univ, Sidney Kimmel Comprehens Canc Ctr, Baltimore, MD USA; Radiotherapy Assoc Sacramento, Sacramento, CA USA; Univ Alabama, Birmingham, AL USA; Akron Hosp, Akron, OH USA; NYU, New York, NY USA; Med Coll Wisconsin, Milwaukee, WI 53226 USA
Note
Publication Date: 2004-07-01.
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