Radiation Therapy With or Without Epoetin Alfa in Treating Patients With Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00017277|
Recruitment Status : Terminated (low accrual)
First Posted : January 27, 2003
Last Update Posted : September 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Biological: epoetin alfa Radiation: radiation therapy||Phase 3|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|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|
|Actual Primary Completion Date :||April 2003|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017277
|Australia, New South Wales|
|Newcastle Mater Misericordiae Hospital|
|Newcastle, New South Wales, Australia, NSW 2310|
|Algemeen Ziekenhuis Middelheim|
|Antwerp, Belgium, 2020|
|Institut Jules Bordet|
|Brussels (Bruxelles), Belgium, 1000|
|Cliniques Universitaires Saint-Luc|
|Brussels (Bruxelles), Belgium, 1200|
|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|