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

September 20, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Newcastle, New South Wales, Australia, NSW 2310
        • Newcastle Mater Misericordiae Hospital
  • Belgium
      • Antwerp, Belgium, 2020
        • Algemeen Ziekenhuis Middelheim
      • Brussels (Bruxelles), Belgium, 1000
        • Institut Jules Bordet
      • Brussels (Bruxelles), Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Haine Saint Paul, Belgium, 7100
        • Hopital de Jolimont
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
      • Namur, Belgium, 5000
        • Clinique Sainte Elisabeth
  • France
      • Villejuif, France, F-94805
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany, D-10117
        • Universitaetsklinikum Charite
  • Hungary
      • Torokbalint, Hungary, H-2045
        • Radius Hungaricus Oncology Group
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
  • Netherlands
      • Heerlen, Netherlands, NL-6401 PC
        • Radiotherapeutisch Instituut Limburg
  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Cruz i Sant Pau
  • Switzerland
      • Bellinzona, Switzerland, CH-6500
        • Ospedale San Giovanni
  • United Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • Beatson Oncology Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

Charite University, Berlin, Germany
Trans Tasman Radiation Oncology Group
Groupe Oncologie Radiotherapie Tete et Cou
Grup per l'Estudi dels Limfomes de Catalunya i Balears
Radius Hungaricus Oncology Group

Investigators

  • Study Chair: Anna Sureda, Hospital de la Santa Cruz i Sant Pau
  • Study Chair: Jacques Bernier, MD, PhD, Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
  • Study Chair: Philippe Lambin, MD, Maastricht University Medical Center
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (Actual)

April 1, 2003

Study Registration Dates

First Submitted

June 6, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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