Trial Information

A Phase III Double-Blind, Randomized, Placebo-Controlled Study of Erythropoietin When Used as an Adjuvant to Radiation Therapy in Patients With Head and Neck Squamous Cell Carcinoma

OBJECTIVES:

- Compare the efficacy of radiotherapy (in terms of local-regional control) with or
without epoetin alfa in patients with squamous cell carcinoma of the head and neck.

- Compare the disease-specific and overall survival of patients treated with these
regimens.

- Compare the hemoglobin level of these patients during radiotherapy.

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

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to participating center, site of disease (larynx vs hypopharynx vs
oropharynx vs oral cavity), T-classification (T1-2 vs T3-4), N-classification and intent of
systematic neck node dissection (N0-1 vs N2-3 without node dissection vs N2-3 with node
dissection), hemoglobin level and gender (men with 10-12.5 g/dL vs men with 12.5-14 g/dL vs
women with 10-12 g/dL vs women with 12-13.5 g/dL), and type of treatment (EORTC standard vs
other vs randomized in other trials). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo standard radiotherapy 5 days a week and receive concurrent
epoetin alfa subcutaneously (SC) once weekly.

- Arm II: Patients undergo radiotherapy as in arm I and receive concurrent placebo SC
once weekly.

Treatment on both arms continues for 6-8 weeks in the absence of disease progression or
unacceptable toxicity.

Patients are followed at 3-6 weeks and 9-14 weeks, every 3 months for 2 years, every 6
months for 1 year, and then annually thereafter. After any locoregional recurrence, patients
are followed every 6 months for 1 year and then annually thereafter.

PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study within 3 years.