Trial Information

Hyperfractionated Radiotherapy With Concomitant Fluorouracil and Hydroxurea for Intermediate Stage Cancer of the Head and Neck

OBJECTIVES:

- Determine the locoregional control rates, time to failure, need for salvage surgery and
overall survival of patients with intermediate stage cancer of the oral cavity,
pharynx, larynx, paranasal sinuses, and cervical esophagus.

- Measure the impact of concomitant Hyper-FHX radiotherapy on organ preservation, organ
function and quality of life parameters.

- Identify possible prognostic factors for toxic effects and response by performing
pharmacologic monitoring.

OUTLINE: Patients receive concomitant chemoradiotherapy with curative intent. Patients who
have microscopic or macroscopic residual disease 6 weeks after completion of
chemoradiotherapy will receive a surgical salvage procedure.

The first cycle of chemotherapy will begin with PO doses of hydroxyurea every 12 hours on
days 0-5. Fluorouracil is given IV on days 0-4. Radiation therapy BID is given on days 1-6.
Cycles repeat every 14 days for a total of 5 cycles.

The disease will be reevaluated 4-6 weeks after completion of all treatment, every 3 months
for 1 year, then yearly.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.