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

    Phase 3
  • Study Type

  • Status

  • Intervention/Treatment

    epoetin ...
  • Study Participants

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may help prevent or treat cancer-related anemia. It is not yet known whether radiation therapy is more effective with or without epoetin alfa in treating head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without epoetin alfa in treating patients who have head and neck cancer.

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.
Study Started
Mar 31
Primary Completion
Apr 30
Last Update
Sep 24

Biological epoetin alfa

Radiation radiation therapy



Histologically confirmed squamous cell carcinoma of the oral cavity, larynx, oropharynx, or hypopharynx

Stage T1-T4, any N
No T1, N0 glottic tumor
No nodal disease from unknown primary
Previously untreated disease
No distant metastases
Planned radiotherapy



18 to 75

Performance status:

WHO 0-2

Life expectancy:

Not specified


Hemoglobin greater than 10 g/dL but no greater than 14 g/dL for men
Hemoglobin greater than 10 g/dL but no greater than 13.5 g/dL for women


Not specified


Not specified


No hypertension (diastolic pressure greater than 100 mmHg) refractory to treatment
No symptomatic cardiovascular disease
No deep vein thrombosis


No other malignancy except cured basal cell skin cancer or carcinoma in situ of the cervix
No psychological, familial, sociological, or geographical condition that would preclude study compliance
No smoking during study
Not pregnant or nursing
Fertile patients must use effective contraception


Biologic therapy:

Not specified


No prior neoadjuvant chemotherapy
No concurrent chemotherapy

Endocrine therapy:

Not specified


See Disease Characteristics
No prior radiotherapy to head and neck area
No concurrent nonconventional radiotherapy


No prior therapeutic surgery to head and neck area
No Results Posted