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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004917 |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may stimulate red blood cell production and treat anemia in patients with head and neck cancer. It is not yet known whether receiving radiation therapy with epoetin alfa is more effective than radiation therapy alone in treating anemic patients with head and neck cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without epoetin alfa in treating anemic patients who have head and neck cancer.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Head and Neck Cancer |
Biological: epoetin alfa Drug: cisplatin Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase III Trial to Assess the Effect of Erythropoietin on Local-Regional Control in Anemic Patients Treated With Radiotherapy for Carcinoma of the Head and Neck |
Study Start Date: | June 2000 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients are stratified according to stage (I/II vs III/IV without chemotherapy vs III/IV with chemotherapy), pretreatment hemoglobin level (9.0 to less than 11.5 g/dL vs 11.5 to 13.5 g/dL), and gender. Patients are randomized to one of two treatment arms.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 372 patients (186 per arm) will be accrued for this study within 3.5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive squamous cell carcinoma of the head and neck, including carcinoma arising from the oral cavity, oropharynx, larynx, and hypopharynx
Anemia, defined as hemoglobin no greater than 13.5 g/dL for males and no greater than 12.5 g/dL for females (transfusion prior to study allowed)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Stage III/IV patients receiving concurrent cisplatin:
Hepatic:
Renal:
Stage III/IV patients receiving concurrent cisplatin:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Mitchell Machtay, MD | University of Pennsylvania |
Study ID Numbers: | CDR0000067599, RTOG-9903, RTOG-DEV-1008 |
Study First Received: | March 7, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004917 History of Changes |
Health Authority: | United States: Federal Government |
stage I squamous cell carcinoma of the lip and oral cavity stage II squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage I squamous cell carcinoma of the oropharynx stage II squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx stage I squamous cell carcinoma of the hypopharynx |
stage II squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage I squamous cell carcinoma of the larynx stage II squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx anemia |
Epoetin Alfa Cisplatin Hematinics Laryngeal Carcinoma Head and Neck Neoplasms Epidermoid Carcinoma |
Anemia Squamous Cell Carcinoma Carcinoma, Squamous Cell Hypopharyngeal Cancer Carcinoma |
Epoetin Alfa Neoplasms Neoplasms by Site Hematinics |
Therapeutic Uses Head and Neck Neoplasms Hematologic Agents Pharmacologic Actions |