RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy plus chemotherapy is more effective than radiation therapy alone in treating patients with advanced head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin with radiation therapy alone in treating patients with advanced head and neck cancer.

OBJECTIVES: I. Assess the time to treatment failure (local and regional) in patients with moderately advanced and advanced squamous cell carcinoma of the head and neck (no distant metastases) when treated with hyperfractionated radiotherapy with vs. without 2 courses of simultaneously administered cisplatin.

II. Assess the time to distant metastatic relapse, overall survival, and toxicity in patients receiving these treatments.

III. Evaluate whether the potential tumor-doubling time is an indicator for risk of treatment failure in patients receiving these treatments.

PROTOCOL OUTLINE: Randomized study.

Arm I: Radiotherapy plus Single-Agent Chemotherapy followed, as indicated, by Surgery. Hyperfractionated external-beam tumor irradiation using photon energies of 4-6 MV or electrons of 6-12 MV (interstitial brachytherapy boost to lesions of the oral cavity allowed); plus Cisplatin, CDDP, NSC-119875; followed, in patients with persistent disease (at the discretion of the surgeon), by resection of primary tumor or involved nodes.

Arm II: Hyperfractionated radiotherapy followed by Surgery. Tumor irradiation as in Arm I; followed by resection as in Arm I.

PROJECTED ACCRUAL: At least 400 patients will be accrued over 5 years. Interim analyses to allow for early stopping will be carried out after entry of 50 and 100 patients.

Ages Eligible for Study:  20 Years   -   75 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically documented squamous cell cancer of the head and neck in the following sites: Hypopharynx; Larynx; Oral cavity; Oropharynx
• Stage III/IV disease; No distant metastases by the following: Chest x-ray (all patients); Liver ultrasound or CT and bone scintigraphy (all hypopharyngeal cancers, those with involved lower neck nodes, and as clinically indicated)
• Multiple sites of disease eligible provided radiotherapy treatment volume remains acceptable

--Prior/Concurrent Therapy--

• No prior treatment for head and neck cancer; Excisional biopsy for diagnosis allowed

--Patient Characteristics--

• Age: 20 to 75
• Performance status: WHO 0-2
• Hematopoietic: WBC greater than 3,000; Platelets greater than 100,000
• Hepatic: Not specified
• Renal: Creatinine clearance at least 60 ml/min; No renal disease or impairment of renal function
• Cardiovascular: No coronary heart disease; No cardiac failure; No history of pulmonary embolism within 2 years
• Other: No clinical hearing impairment; No peripheral neuropathy with concomitant handicap; No severe diabetes mellitus with serious vasculopathy or neuropathy; No second cancer except: Nonmelanomatous skin or lip cancer; In situ carcinoma of the cervix
• Blood/body fluid analyses to determine eligibility completed within 14 days prior to registration