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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00017277




Registration number
NCT00017277
Ethics application status
Date submitted
6/06/2001
Date registered
27/01/2003
Date last updated
24/09/2012

Titles & IDs
Public title
Radiation Therapy With or Without Epoetin Alfa in Treating Patients With Head and Neck Cancer
Scientific 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
Secondary ID [1] 0 0
EORTC-22996
Secondary ID [2] 0 0
EORTC-22996-24002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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 age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Newcastle Mater Misericordiae Hospital - Newcastle
Recruitment postcode(s) [1] 0 0
NSW 2310 - Newcastle
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerp
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels (Bruxelles)
Country [3] 0 0
Belgium
State/province [3] 0 0
Haine Saint Paul
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
Belgium
State/province [5] 0 0
Namur
Country [6] 0 0
France
State/province [6] 0 0
Villejuif
Country [7] 0 0
Germany
State/province [7] 0 0
Berlin
Country [8] 0 0
Hungary
State/province [8] 0 0
Torokbalint
Country [9] 0 0
Israel
State/province [9] 0 0
Haifa
Country [10] 0 0
Netherlands
State/province [10] 0 0
Heerlen
Country [11] 0 0
Spain
State/province [11] 0 0
Barcelona
Country [12] 0 0
Switzerland
State/province [12] 0 0
Bellinzona
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Scotland

Funding & Sponsors
Primary sponsor type
Other
Name
European Organisation for Research and Treatment of Cancer - EORTC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Trans Tasman Radiation Oncology Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Charite University, Berlin, Germany
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Groupe Oncologie Radiotherapie Tete et Cou
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Radius Hungaricus Oncology Group
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Grup per l'Estudi dels Limfomes de Catalunya i Balears
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00017277
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Philippe Lambin, MD
Address 0 0
Maastricht University Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00017277