PHASE III INTERGROUP TRIAL OF SURGERY FOLLOWED BY (1) RADIOTHERAPY VS. (2) RADIOCHEMOTHERAPY FOR RESECTABLE HIGH RISK SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK

Inclusion Criteria

DISEASE CHARACTERISTICS: Biopsy-proven squamous cell carcinoma of one of the following
sites: Hypopharynx Larynx Oral cavity Oropharynx At least 1 of the following high-risk
factors required: Histologic extracapsular nodal extension Histologic involvement of 2 or
more regional lymph nodes Microscopically positive mucosal margins Complete resection of
all visible and palpable disease Therapy must begin within 8 weeks of tumor-related
surgery Bilateral resections may or may not be performed simultaneously Eligibility window
begins with first definitive surgery Neck dissection not required for T4 N0, truly midline
supraglottic tumors No tumors of the lip, nasopharynx, or sinuses No synchronous or
concurrent head and neck tumors No evidence of distant metastasis Concurrent registration
on Fixed Tumor Repository Study allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100%
Hematopoietic: WBC at least 3,500 Platelets at least 100,000 Hepatic: Not specified Renal:
Creatinine clearance greater than 50 mL/min Other: No medical contraindication to protocol
therapy No second malignancy within 5 years No pregnant or nursing women

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to head
and neck region Surgery: See Disease Characteristics