NCT00017277

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 Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at below P25 for phase_3 head-and-neck-cancer

Geographic Reach
10 countries

15 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2001

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

2.1 years

First QC Date

June 6, 2001

Last Update Submit

September 20, 2012

Conditions

Head and Neck Cancer

Keywords

stage I squamous cell carcinoma of the lip and oral cavitystage II squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the lip and oral cavitystage I squamous cell carcinoma of the oropharynxstage II squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the oropharynxstage I squamous cell carcinoma of the hypopharynxstage II squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxstage I squamous cell carcinoma of the larynxstage II squamous cell carcinoma of the larynxstage III squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the larynx

Interventions

epoetin alfaBIOLOGICAL
radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (15)

Newcastle Mater Misericordiae Hospital

Newcastle, New South Wales, NSW 2310, Australia

Location

Algemeen Ziekenhuis Middelheim

Antwerp, 2020, Belgium

Location

Institut Jules Bordet

Brussels (Bruxelles), 1000, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels (Bruxelles), 1200, Belgium

Location

Hopital de Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Clinique Sainte Elisabeth

Namur, 5000, Belgium

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Universitaetsklinikum Charite

Berlin, D-10117, Germany

Location

Radius Hungaricus Oncology Group

Törökbálint, H-2045, Hungary

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Radiotherapeutisch Instituut Limburg

Heerlen, NL-6401 PC, Netherlands

Location

Hospital de la Santa Cruz I Sant Pau

Barcelona, 08025, Spain

Location

Ospedale San Giovanni

Bellinzona, CH-6500, Switzerland

Location

Beatson Oncology Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Related 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 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.

    PMID: 16782926RESULT

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

Epoetin AlfaRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsTherapeutics

Study Officials

  • Philippe Lambin, MD

    Maastricht University Medical Center

    STUDY CHAIR

  • Jacques Bernier, MD, PhD

    Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

    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

    STUDY CHAIR

  • Anna Sureda

    Hospital de la Santa Cruz i Sant Pau

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2001

First Posted

January 27, 2003

Study Start

March 1, 2001

Primary Completion

April 1, 2003

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

HU(1)AU(1)NL(1)GB(1)FR(1)CH(1)BE(6)IL(1)DE(1)ES(1)