Head and Neck CancerPhase 3NCT00017277
Radiation Therapy With or Without Epoetin Alfa in Treating Patients With Head and Neck Cancer
A Phase 3 study testing epoetin alfa and radiation therapy in people with Head and Neck Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 15 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- epoetin alfa and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 47 participants
- Where
- 15 sitesin 10 countries
- Study dates
- Mar 2001to Apr 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
15 sites in 10 countries.
15 sites in 10 countries
Belgium6 sites
Algemeen Ziekenhuis Middelheim
Antwerp, 2020
Institut Jules Bordet
Brussels (Bruxelles), 1000
Cliniques Universitaires Saint-Luc
Brussels (Bruxelles), 1200
Hopital de Jolimont
Haine-Saint-Paul, 7100
U.Z. Gasthuisberg
Leuven, B-3000
Clinique Sainte Elisabeth
Namur, 5000
Australia1 site
Newcastle Mater Misericordiae Hospital
Newcastle, New South Wales, NSW 2310
Netherlands1 site
Radiotherapeutisch Instituut Limburg
Heerlen, NL-6401 PC
United Kingdom1 site
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
About this study
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
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- epoetin alfa, radiation therapy
- 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
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetin alfaBiological
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 2001
- Primary completionApr 2003
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Collaborators
- Trans Tasman Radiation Oncology Group, Charite University, Berlin, Germany, Groupe Oncologie Radiotherapie Tete et Cou, Radius Hungaricus Oncology Group, Grup per l'Estudi dels Limfomes de Catalunya i Balears
- Responsible party
- Sponsor
- Investigators
- Philippe Lambin, MD, Study chair, Maastricht University Medical CenterJacques Bernier, MD, PhD, Study chair, Istituto Oncologico della Svizzera Italiana - Ospedale San GiovanniJim Denham, MD, Study chair, Newcastle Mater Misericordiae HospitalVolker G. Budach, MD, PhD, Study chair, Charite University, Berlin, GermanyJean-Henri Bourhis, MD, PhD, Study chair, Gustave Roussy, Cancer Campus, Grand ParisFerenc Kaldau, MD, Study chair, Radius Hungaricus Oncology GroupAnna Sureda, Study chair, Hospital de la Santa Cruz i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00017277
- Sponsor's protocol ID
- EORTC-22996-24002
- Other IDs
- EORTC-22996, ARO-EORTC-22996, EORTC-HN-22996, GORTEC-EORTC-22996, TROG-EORTC-22996, RHOG-EORTC-22996, GELCB-EORTC-22996
- Status last verified
- Sep 2012
- First submitted
- 6 Jun 2001
- Last updated
- 24 Sep 2012
- Results posted
- No
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.
PubMed 16782926
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00017277
- Acronym / sponsor ID
- EORTC-22996-24002
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 47 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Collaborators
- Trans Tasman Radiation Oncology Group, Charite University, Berlin, Germany, Groupe Oncologie Radiotherapie Tete et Cou, Radius Hungaricus Oncology Group, Grup per l'Estudi dels Limfomes de Catalunya i Balears
- Study start
- Mar 2001
- Primary completion
- Apr 2003 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epoetin alfa | Biological | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
- Results publication: PubMed 16782926Bourhis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Lambin, MD study chair
Maastricht University Medical Center
Jacques Bernier, MD, PhD study chair
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
Jim Denham, MD study chair
Newcastle Mater Misericordiae Hospital
15 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing epoetin alfa and radiation therapy in people with Head and Neck Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 15 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Belgium, Australia, France, Germany, Hungary and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00017277, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.