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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00017277
• Other study ID #: EORTC-22996-24002
• Secondary ID: EORTC-22996ARO-E
• Status: Terminated
• Phase: Phase 3
• First received: June 6, 2001
• Last updated: September 20, 2012
• Start date: March 2001

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Biological:
• epoetin alfa

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Australia	Newcastle Mater Misericordiae Hospital	Newcastle	New South Wales
Belgium	Algemeen Ziekenhuis Middelheim	Antwerp
Belgium	Cliniques Universitaires Saint-Luc	Brussels (Bruxelles)
Belgium	Institut Jules Bordet	Brussels (Bruxelles)
Belgium	Hopital de Jolimont	Haine Saint Paul
Belgium	U.Z. Gasthuisberg	Leuven
Belgium	Clinique Sainte Elisabeth	Namur
France	Institut Gustave Roussy	Villejuif
Germany	Universitaetsklinikum Charite	Berlin
Hungary	Radius Hungaricus Oncology Group	Torokbalint
Israel	Rambam Medical Center	Haifa
Netherlands	Radiotherapeutisch Instituut Limburg	Heerlen
Spain	Hospital de la Santa Cruz I Sant Pau	Barcelona
Switzerland	Ospedale San Giovanni	Bellinzona
United Kingdom	Beatson Oncology Centre	Glasgow	Scotland

Sponsors (6)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC	Charite University, Berlin, Germany, Groupe Oncologie Radiotherapie Tete et Cou, Grup per l'Estudi dels Limfomes de Catalunya i Balears, Radius Hungaricus Oncology Group, Trans-Tasman Radiation Oncology Group (TROG)

Countries where clinical trial is conducted

Australia,  Belgium,  France,  Germany,  Hungary,  Israel,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

References & Publications (1)

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 t — View Citation