Head and Neck Cancer Clinical Trial
Official title:
Phase II Multi-Institutional Trial of Targeted Supradose Cisplatin Chemoradiation for Stage IV Squamous Cell Carcinoma of the Head and Neck
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor
cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of cisplatin and radiation therapy in
treating patients with stage IV cancer of the head and neck.
OBJECTIVES: I. Determine the percentage of patients for whom a complete course of therapy
can be administered using targeted supradose cisplatin chemoradiation in patients with
squamous cell carcinoma of the head and neck. II. Determine the partial and complete
response rate of cisplatin chemoradiation. III. Determine the incidence of adverse events
using cisplatin chemoradiation therapy. IV. Determine the rate of disease-free survival and
overall survival in these patients. V. Determine the incidence and pattern of recurrence in
these patients. VI. Document quality of life measured by disease-specific instruments in
these patients.
OUTLINE: All patients receive four courses of cisplatin on days 1, 8, 15, and 22 concurrent
with radiotherapy. One course of chemotherapy consists of intra-arterial cisplatin given
over 3-5 minutes. Radiotherapy is given 5 days a week for 7 weeks. This weekly cisplatin
chemoradiation course will be repeated 4 times, providing recovery from toxicity is present.
Dexamethasone is started the evening prior to cisplatin treatment, and continues until the
morning following the procedure.
PROJECTED ACCRUAL: 60 patients will be enrolled.
;
Primary Purpose: Treatment
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