Head and Neck Cancer Clinical Trial
Official title:
Phase II Study - Efficacy of Amifostine in Alleviating Toxicity Associated With Targeted Supradose Cisplatin and Concomitant Radiation Therapy (RADPLAT) in Head and Neck Cancer
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. Drugs such as amifostine may protect normal cells from the side effects of chemotherapy
and radiation therapy.
PURPOSE: Phase II trial to study the effectiveness of amifostine in treating side effects of
treatment in patients receiving radiation therapy and cisplatin for advanced head and neck
cancer.
OBJECTIVES: I. Determine the efficacy of amifostine in alleviating treatment related
mucositis associated with targeted supradose cisplatin and concurrent radiotherapy (RADPLAT
protocol) in patients with stage III or IV squamous cell carcinoma of the head and neck. II.
Determine the efficacy of amifostine in alleviating other treatment related morbidities
associated with this protocol in these patients.
OUTLINE: This is an open label, multicenter study of amifostine. Patients receive external
beam radiotherapy 5 days a week for approximately 6.5-7.5 weeks. Concurrent with
radiotherapy, patients receive amifostine IV over 10 minutes, 30 minutes prior to cisplatin,
then cisplatin intra-arterially over 3-5 minutes. Chemotherapy and amifostine course is
repeated every week for 4 weeks. Patients are followed at 1 month.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued into this study over 12-18
months.
;
Primary Purpose: Supportive Care
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