Clinical trial NCT00017277: Radiation Therapy With or Without Epoetin Alfa in Treating Patients With Head and Neck Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Head and Neck Cancer
Keywords: 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
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
Collaborators: name: Trans Tasman Radiation Oncology Group
name: Charite University, Berlin, Germany
name: Groupe Oncologie Radiotherapie Tete et Cou
name: Radius Hungaricus Oncology Group
name: Grup per l'Estudi dels Limfomes de Catalunya i Balears
First posted: 2003-01-27
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Newcastle
country: Australia
facility: Newcastle Mater Misericordiae Hospital
state: New South Wales
city: Antwerp
country: Belgium
facility: Algemeen Ziekenhuis Middelheim
city: Brussels (Bruxelles)
country: Belgium
facility: Institut Jules Bordet
city: Brussels (Bruxelles)
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Haine Saint Paul
country: Belgium
facility: Hopital de Jolimont
city: Leuven
country: Belgium
facility: U.Z. Gasthuisberg
city: Namur
country: Belgium
facility: Clinique Sainte Elisabeth
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Universitaetsklinikum Charite
city: Torokbalint
country: Hungary
facility: Radius Hungaricus Oncology Group
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Heerlen
country: Netherlands
facility: Radiotherapeutisch Instituut Limburg
city: Barcelona
country: Spain
facility: Hospital de la Santa Cruz I Sant Pau
city: Bellinzona
country: Switzerland
facility: Ospedale San Giovanni
city: Glasgow
country: United Kingdom
facility: Beatson Oncology Centre
state: Scotland
Study officials:
affiliation: Maastricht University Medical Center
name: Philippe Lambin, MD
role: STUDY_CHAIR
affiliation: Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
name: Jacques Bernier, MD, PhD
role: STUDY_CHAIR
affiliation: Newcastle Mater Misericordiae Hospital
name: Jim Denham, MD
role: STUDY_CHAIR
affiliation: Charite University, Berlin, Germany
name: Volker G. Budach, MD, PhD
role: STUDY_CHAIR
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Jean-Henri Bourhis, MD, PhD
role: STUDY_CHAIR
affiliation: Radius Hungaricus Oncology Group
name: Ferenc Kaldau, MD
role: STUDY_CHAIR
affiliation: Hospital de la Santa Cruz i Sant Pau
name: Anna Sureda
role: STUDY_CHAIR
References:
citation: 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.