Trial Information

Surgery and Adjuvant Radiotherapy Versus Concurrent Chemo-Radiotherapy for Resectable (Non-Metastatic) Stage III/IV Head and Neck Squamous Cell Cancer

OBJECTIVES:

- Compare the complete response rate, disease-free survival, and overall survival of
patients with resectable (nonmetastatic) stage III or IV squamous cell cancer of the
head and neck treated with surgery and adjuvant radiotherapy versus concurrent
chemo-radiotherapy.

OUTLINE: This is a randomized study. Patients are stratified according to primary site of
disease (oral cavity/oropharynx vs larynx/hypopharynx vs others) and nodal status (node
negative vs positive).

- Arm I: Patients undergo resection of the tumor, followed no more than 6 weeks later by
radiotherapy to the primary tumor and upper neck once a day, 5 days a week, for 6
weeks.

- Arm II: Patients undergo radiotherapy in addition to chemotherapy with fluorouracil and
cisplatin. Radiotherapy is given once a day, 5 days a week, for 6.5 weeks to the
primary tumor and upper neck. Fluorouracil and cisplatin are administered by continuous
infusion for 4 days beginning on day 1 of the first week of radiotherapy. A second
course of fluorouracil and cisplatin is given on day 28.

Patients who have failed or are suspected to have failed chemo-radiotherapy should be
considered for salvage surgery.

Patients are followed once a month for the first year, every 2 months for the second year,
every 3 months for the third year, and every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 200 patients will be accrued over a 4-5 year period.