Trial Information

Phase III Randomized Study of Radiotherapy With or Without Cisplatin and Fluorouracil for Locally Advanced, Nonresectable Squamous Cell Cancer of the Oropharynx or Hypopharynx

OBJECTIVES:

- Compare the overall survival and survival without relapse for 1, 3, and 5 years of
patients with squamous cell cancer of the oropharynx or hypopharynx after treatment
with twice a day radiotherapy with or without cisplatin and fluorouracil.

- Compare the presence of distant metastases at 1, 3, and 5 years in these patients after
these treatments.

- Compare the local control and duration of control in these patients after these
treatments.

- Compare the clinical changes and histological changes at 6 months in these patients
after these treatments.

- Determine the rate of complete response in these patients after these treatments.

- Determine the early and late toxic effects of these regimens in these patients.

- Determine the quality of life of these patients.

- Determine the pharmacokinetics of fluorouracil and tolerability of this regimen in
these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center and primary site of disease (oropharynx vs hypopharynx)

Patients are randomized to one of two treatment arms.

- Arm I: Patients undergo radiotherapy twice a day, 6 hours apart, 5 days a week, for 7
weeks.

- Arm II: Patients undergo radiotherapy as in arm I, plus concurrent chemotherapy
consisting of cisplatin IV on day 1 and fluorouracil by continuous infusion over 24
hours on days 1-5. Courses are repeated every 3 weeks for 3 courses.

Patients are followed every month for 1 year, every 2-3 months for 2 years, then every 6
months for at least 2 years.

PROJECTED ACCRUAL: A total of 160 patients (80/arm) will be accrued for this study within
4.5 years.