Prospective Evaluation of Unilateral/Ipsilateral Neck Irradiation Combined with Amifostine in Selected Patients with Squamous Cell Carcinoma of the Head and Neck Who are Managed by Radiation Therapy.

Summary:
The purpose of this study is to evaluate the effects of delivering radiation to only one side of the head/neck, and to investigate whether the addition of Amifostine can lessen the side effects of the radiation therapy. Amifostine is a FDA approved drug that selectively protects normal cells, and has been demonstrated to decrease the incidence of severe radiation-related dry mouth and painful inflammation and sores in the mouth and throat in head and neck cancer.

Eligibility and Treatment Plan:
Patients, 18 years and older, with squamous cell carcinoma (cancer) of the oral cavity or oropharynx, with no clinical or radiologic evidence of contralateral (on other side) neck node metastases.

All patients will receive daily radiation therapy. Patients will be randomized to receive either Amifostine + radiation therapy, or radiation therapy alone. Chemotherapy (Cisplatin) may be given to patients with stages III and IV disease if clinically appropriate.