Radiation Therapy With or Without Epoetin Alfa in Treating Patients With Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00017277
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 47
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Institut Jules Bordet
🇧🇪Brussels (Bruxelles), Belgium
Institut Gustave Roussy
🇫🇷Villejuif, France
Rambam Medical Center
🇮🇱Haifa, Israel
Universitaetsklinikum Charite
🇩🇪Berlin, Germany
Beatson Oncology Centre
🇬🇧Glasgow, Scotland, United Kingdom
Cliniques Universitaires Saint-Luc
🇧🇪Brussels (Bruxelles), Belgium
Hopital de Jolimont
🇧🇪Haine Saint Paul, Belgium
Clinique Sainte Elisabeth
🇧🇪Namur, Belgium
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Radiotherapeutisch Instituut Limburg
🇳🇱Heerlen, Netherlands
Ospedale San Giovanni
🇨ðŸ‡Bellinzona, Switzerland
Algemeen Ziekenhuis Middelheim
🇧🇪Antwerp, Belgium
Hospital de la Santa Cruz I Sant Pau
🇪🇸Barcelona, Spain
Radius Hungaricus Oncology Group
ðŸ‡ðŸ‡ºTorokbalint, Hungary
Newcastle Mater Misericordiae Hospital
🇦🇺Newcastle, New South Wales, Australia