Radiation Therapy With or Without Epoetin Alfa in Treating Anemic Patients With Head and Neck Cancer

OBJECTIVES:

Primary

* Determine whether epoetin alfa given during definitive radiotherapy or chemoradiotherapy improves the local-regional control rate in anemic patients with squamous cell carcinoma of the head and neck.

Secondary

* Determine whether this drug improves survival in this patient population. * Identify patterns in first failure in these patients. * Determine whether there is a significant increase in hemoglobin level between the baseline value and the value at 28 days after starting epoetin alfa in these patients. * Assess the toxicity of this regimen in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to stage (I/II vs III/IV without chemotherapy vs III/IV with chemotherapy), pretreatment hemoglobin level (9.0 to less than 11.5 g/dL vs 11.5 to 13.5 g/dL), and gender. Patients are randomized to one of two treatment arms.

* Arm I: Patients with stage I or II disease undergo radiotherapy once daily for 6-7 weeks. Patients with stage III or IV disease undergo radiotherapy once daily for 3.5 weeks and then twice daily (6 hours apart) for 2.5 weeks for a total of 6 weeks. * Arm II: Patients undergo radiotherapy as in arm I. Beginning 7-10 days before radiotherapy, patients receive epoetin alfa subcutaneously once weekly until the end of radiotherapy.

Patients with stage III/IV disease may receive concurrent cisplatin IV over 1-2 hours on days 1 and 22 of radiotherapy.

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

PROJECTED ACCRUAL: A total of 372 patients (186 per arm) will be accrued for this study within 3.5 years.