Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)

TRIAL DESIGN: Phase III trial of induction therapy with docetaxel followed by chemoradiotherapy versus chemoradiotherapy alone in patients with nodal stage N2 or N3 head and neck cancer OBJECTIVES: Primary * To determine the effect on overall survival when induction chemotherapy is administered prior to chemoradiotherapy in patients with N2 or N3 disease. Secondary * To determine the effect of induction chemotherapy when administered prior to chemoradiotherapy on distant failure-free survival, failure pattern, progression free survival and quality of life. TREATMENT PLAN: * After eligibility is confirmed, patients will be randomized to one of two treatment arms: Arm A - Induction + chemoradiotherapy Arm B - Chemoradiotherapy alone * Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (day 1), cisplatin (day 1), and 5-fluorouracil (days 1-5). Total duration of 6 weeks. * Chemoradiotherapy: Five 14-day cycles of docetaxel (day 1), 5-fluorouracil (day 0-4), and hydroxyurea (days 0-4) with twice daily radiation (days 1-5). Total duration of 10 weeks. * All patients will undergo surgical evaluation after chemoradiation for possible neck dissection. * Upon completion of treatment, patients will be monitored every three months during the first year, every six months during the second and third years, and annually thereafter, up to seven years. * Patients will be followed for Quality of Life (QOL) during the course of treatment, as well as annually thereafter, up to five years. PROJECTED ACCRUAL: * An expected sample size of 400 patients will be enrolled for this study (200 per treatment arm).