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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Head and Neck Cancer

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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epoetin alfa

Intervention Type BIOLOGICAL

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Lambin, MD

Role: STUDY_CHAIR

Maastricht University Medical Center

Jacques Bernier, MD, PhD

Role: STUDY_CHAIR

Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

Jim Denham, MD

Role: STUDY_CHAIR

Newcastle Mater Misericordiae Hospital

Volker G. Budach, MD, PhD

Role: STUDY_CHAIR

Charite University, Berlin, Germany

Jean-Henri Bourhis, MD, PhD

Role: STUDY_CHAIR

Gustave Roussy, Cancer Campus, Grand Paris

Ferenc Kaldau, MD

Role: STUDY_CHAIR

Radius Hungaricus Oncology Group

Anna Sureda

Role: STUDY_CHAIR

Hospital de la Santa Cruz i Sant Pau

Locations

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Newcastle Mater Misericordiae Hospital

Newcastle, New South Wales, Australia

Site Status

Algemeen Ziekenhuis Middelheim

Antwerp, , Belgium

Site Status

Institut Jules Bordet

Brussels (Bruxelles), , Belgium

Site Status

Cliniques Universitaires Saint-Luc

Brussels (Bruxelles), , Belgium

Site Status

Hopital de Jolimont

Haine-Saint-Paul, , Belgium

Site Status

U.Z. Gasthuisberg

Leuven, , Belgium

Site Status

Clinique Sainte Elisabeth

Namur, , Belgium

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Universitaetsklinikum Charite

Berlin, , Germany

Site Status

Radius Hungaricus Oncology Group

Törökbálint, , Hungary

Site Status

Rambam Medical Center

Haifa, , Israel

Site Status

Radiotherapeutisch Instituut Limburg

Heerlen, , Netherlands

Site Status

Hospital de la Santa Cruz I Sant Pau

Barcelona, , Spain

Site Status

Ospedale San Giovanni

Bellinzona, , Switzerland

Site Status

Beatson Oncology Centre

Glasgow, Scotland, United Kingdom

Site Status

Countries

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Australia Belgium France Germany Hungary Israel Netherlands Spain Switzerland United Kingdom

References

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Bourhis J, Lapeyre M, Tortochaux J, Rives M, Aghili M, Bourdin S, Lesaunier F, Benassi T, Lemanski C, Geoffrois L, Lusinchi A, Verrelle P, Bardet E, Julieron M, Wibault P, Luboinski M, Benhamou E. Phase III randomized trial of very accelerated radiation therapy compared with conventional radiation therapy in squamous cell head and neck cancer: a GORTEC trial. J Clin Oncol. 2006 Jun 20;24(18):2873-8. doi: 10.1200/JCO.2006.08.057.

Reference Type RESULT

PMID: 16782926 (View on PubMed)