Radiation Therapy With or Without Epoetin Alfa in Treating Patients With Head and Neck Cancer

This study has been terminated.
(low accrual)
Sponsor:
Collaborators:
Trans-Tasman Radiation Oncology Group (TROG)
Charite University, Berlin, Germany
Groupe Oncologie Radiotherapie Tete et Cou
Radius Hungaricus Oncology Group
Grup per l'Estudi dels Limfomes de Catalunya i Balears
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00017277
First received: June 6, 2001
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Head and Neck Cancer
Biological: epoetin alfa
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 47
Study Start Date: March 2001
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017277

Locations
Australia, New South Wales
Newcastle Mater Misericordiae Hospital
Newcastle, New South Wales, Australia, NSW 2310
Belgium
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
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Clinique Sainte Elisabeth
Namur, Belgium, 5000
France
Institut Gustave Roussy
Villejuif, France, F-94805
Germany
Universitaetsklinikum Charite
Berlin, Germany, D-10117
Hungary
Radius Hungaricus Oncology Group
Torokbalint, Hungary, H-2045
Israel
Rambam Medical Center
Haifa, Israel, 31096
Netherlands
Radiotherapeutisch Instituut Limburg
Heerlen, Netherlands, NL-6401 PC
Spain
Hospital de la Santa Cruz I Sant Pau
Barcelona, Spain, 08025
Switzerland
Ospedale San Giovanni
Bellinzona, Switzerland, CH-6500
United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Trans-Tasman Radiation Oncology Group (TROG)
Charite University, Berlin, Germany
Groupe Oncologie Radiotherapie Tete et Cou
Radius Hungaricus Oncology Group
Grup per l'Estudi dels Limfomes de Catalunya i Balears
Investigators
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
  More Information

Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00017277     History of Changes
Other Study ID Numbers: EORTC-22996-24002, EORTC-22996, ARO-EORTC-22996, EORTC-HN-22996, GORTEC-EORTC-22996, TROG-EORTC-22996, RHOG-EORTC-22996, GELCB-EORTC-22996
Study First Received: June 6, 2001
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014