Radiation Therapy With or Without Epoetin Alfa in Treating Patients With Head and Neck Cancer
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.
Head and Neck Cancer
Biological: epoetin alfa
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||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|
|Study Start Date:||March 2001|
|Primary Completion Date:||April 2003 (Final data collection date for primary outcome measure)|
- 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.
|Australia, New South Wales|
|Newcastle Mater Misericordiae Hospital|
|Newcastle, New South Wales, Australia, NSW 2310|
|Algemeen Ziekenhuis Middelheim|
|Antwerp, Belgium, 2020|
|Cliniques Universitaires Saint-Luc|
|Brussels (Bruxelles), Belgium, 1200|
|Institut Jules Bordet|
|Brussels (Bruxelles), Belgium, 1000|
|Hopital de Jolimont|
|Haine Saint Paul, Belgium, 7100|
|Leuven, Belgium, B-3000|
|Clinique Sainte Elisabeth|
|Namur, Belgium, 5000|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Berlin, Germany, D-10117|
|Radius Hungaricus Oncology Group|
|Torokbalint, Hungary, H-2045|
|Rambam Medical Center|
|Haifa, Israel, 31096|
|Radiotherapeutisch Instituut Limburg|
|Heerlen, Netherlands, NL-6401 PC|
|Hospital de la Santa Cruz I Sant Pau|
|Barcelona, Spain, 08025|
|Ospedale San Giovanni|
|Bellinzona, Switzerland, CH-6500|
|Beatson Oncology Centre|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Study Chair:||Philippe Lambin, MD||Maastricht University Medical Center|
|Study Chair:||Jacques Bernier, MD, PhD||Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni|
|Study Chair:||Jim Denham, MD||Newcastle Mater Misericordiae Hospital|
|Study Chair:||Volker G. Budach, MD, PhD||Charite University, Berlin, Germany|
|Study Chair:||Jean-Henri Bourhis, MD, PhD||Gustave Roussy, Cancer Campus, Grand Paris|
|Study Chair:||Ferenc Kaldau, MD||Radius Hungaricus Oncology Group|
|Study Chair:||Anna Sureda||Hospital de la Santa Cruz i Sant Pau|