Title
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 3Study Type
InterventionalStatus
TerminatedIndication/Condition
Head and Neck CancerIntervention/Treatment
epoetin ...Study Participants
47RATIONALE: 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.
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.
DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: 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 Hepatic: Not specified Renal: Not specified Cardiovascular: No hypertension (diastolic pressure greater than 100 mmHg) refractory to treatment No symptomatic cardiovascular disease No deep vein thrombosis Other: 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 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior neoadjuvant chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to head and neck area No concurrent nonconventional radiotherapy Surgery: No prior therapeutic surgery to head and neck area
