Trial Information

A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas

OBJECTIVES:

Primary

- Compare overall survival of patients with stage III or IV squamous cell carcinoma of
the head and neck treated with conventional vs accelerated radiotherapy and concurrent
cisplatin with or without surgical resection.

Secondary

- Compare local-regional control of disease and disease-free rates in patients treated
with these regimens.

- Compare the acute and late toxicity of these regimens in these patients.

- Compare quality of life, perception of side effects, and performance status of patients
treated with these regimens.

- Determine whether epidermal growth factor receptor and cyclo-oxygenase-2 expressions
are independent prognostic markers in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor
site (larynx vs other), nodal stage (N0 vs N1 or N2a or N2b vs N2c or N3), and Zubrod
performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo standard fractionation radiotherapy 5 days a week for 7 weeks.
Patients also receive cisplatin IV on days 1, 22, and 43.

- Arm II: Patients undergo accelerated fractionation radiotherapy 5 days a week for 3.5
weeks and then twice a day, 5 days a week, for 2.5 weeks. Patients also receive
cisplatin IV on days 1 and 22.

Patients with biopsy-proven relapsed disease more than 3 months after completion of therapy
undergo surgical resection of the primary tumor.

Quality of life is assessed at baseline, during one of the last 2 weeks of treatment, at 3
and 12 months, and then annually for 4 years.

Patients are followed at 6-8 weeks, every 3 months for 2 years, every 6 months for 3 years,
and then annually thereafter.

PROJECTED ACCRUAL: A total of 720 patients (360 per treatment arm) will be accrued for this
study within 3 years.