Epidermoid Head and Neck CancerNCT01647555
Radiotherapy in Association With Cetuximab in Patients Treated for an Epidermoid Cancer
An observational study of Epidermoid Head and Neck Cancer, run by Centre Oscar Lambret at 7 sites in France.
Trial summary
This study evaluates the skin toxicities in patients with epidermoid cancer, treated by Radiotherapy in association with Cetuximab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epidermoid Head and Neck Cancer
- What is being tested?
- Cetuximab and Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 57 participants
- Where
- 7 sitesFrance
- Study dates
- 6 Oct 2006to Oct 2014
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with epidermoid head and neck cancer locally advanced
Who may be able to join
- Age > 18 years
- Epidermoid head and neck carcinoma locally advanced
- Indication of Cetuximab and radiotherapy
- Karnofsky >= 60
- Patients participating to another compatible study could be included after consultation with the study director Patients could be beforehand treated for an other ORL cancer
- The radiotherapy will be delivered for curative aim (minimal dose 66 Gy)
Who cannot join
- other histology
- Metastatic disease
- Recurrent patients
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Clinique du Parc
Croix, 599962
Centre Leonard de Vinci
Douai, 59500
Centre Bourgogne
Lille, 59000
Centre Oscar Lambret
Lille, 59020
Centre Galilée
Lille, 59045
Centre Gray
Maubeuge, 59600
Centre Joliot Curie
Saint-Martin-Boulogne, 62280
About this study
Official title: Prospective Study About the Association of Radiotherapy and Cetuximab in the Treatment of Epidermoid Cancers, Locally Advanced, of the Head and Neck.
This study evaluates the skin toxicities in patients with epidermoid cancer, treated by Radiotherapy in association with Cetuximab.
Read the detailed description
This prospective and multicentric study evaluates the skin toxicities in patients with locally Advanced head and neck epidermoid cancer, treated by Radiotherapy in association with Cetuximab.
- Conditions
- Epidermoid Head and Neck Cancer
- Being tested
- Cetuximab, Radiotherapy
- Keywords
- Cetuximab, radiotherapy, epidermoid head and neck cancer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
First cycle: 400 mg/m2 Next cycles: 250 mg/m2
RadiotherapyRadiation
Curative dose: 66 to 70 Gy
| Study group | Role | What they receive |
|---|---|---|
| patient with epidermoid cancer | receiving Cetuximab and radiotherapy Receives: Drug: Cetuximab; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin toxicities
according to NCI-CTCAE version 3.0
Measured: until week 38
Secondary outcomes (3)
Healthcare and evolution of skin toxicities
Treatment of skin toxicities, according to sponsor advices.
Measured: until week 38
Quality of life reporting
Questionnaire QLQ-C30
Measured: baseline, week 4, month 6
tumoral efficacy
According to RECIST criteria
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study start6 Oct 2006
- Primary completionOct 2012
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidermoid Head and Neck CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric LARTIGAU, MD, PhD, Study director, Oscar Lambret Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647555
- Sponsor's protocol ID
- ESPACE
- Status last verified
- Sep 2020
- First submitted
- 19 Jul 2012
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study About the Association of Radiotherapy and Cetuximab in the Treatment of Epidermoid Cancers, Locally Advanced, of the Head and Neck.
- ClinicalTrials.gov ID
- NCT01647555
- Acronym / sponsor ID
- ESPACE
- Conditions
- Epidermoid Head and Neck Cancer
- Keywords
- Cetuximab, radiotherapy, epidermoid head and neck cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 6 Oct 2006 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 23 Jul 2012 (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.
This study evaluates the skin toxicities in patients with epidermoid cancer, treated by Radiotherapy in association with Cetuximab.
Detailed description
This prospective and multicentric study evaluates the skin toxicities in patients with locally Advanced head and neck epidermoid cancer, treated by Radiotherapy in association with Cetuximab.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with epidermoid cancer | – | Drug: Cetuximab, Radiation: Radiotherapyreceiving Cetuximab and radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with epidermoid head and neck cancer locally advanced
Key inclusion criteria (6 listed)
- Age > 18 years
- Epidermoid head and neck carcinoma locally advanced
- Indication of Cetuximab and radiotherapy
- Karnofsky >= 60
- Patients participating to another compatible study could be included after consultation with the study director Patients could be beforehand treated for an other ORL cancer
Key exclusion criteria (3 listed)
- other histology
- Metastatic disease
- Recurrent patients
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 |
|---|---|---|
| CetuximabFirst cycle: 400 mg/m2 Next cycles: 250 mg/m2 | Drug | patient with epidermoid cancer |
| RadiotherapyCurative dose: 66 to 70 Gy | Radiation | patient with epidermoid cancer |
Primary outcome
Skin toxicities
Time frame: until week 38
according to NCI-CTCAE version 3.0
3 secondary outcomes
Healthcare and evolution of skin toxicities
Time frame: until week 38
Quality of life reporting
Time frame: baseline, week 4, month 6
tumoral efficacy
Time frame: 6 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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.
Eric LARTIGAU, MD, PhD study director
Oscar Lambret Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidermoid Head and Neck Cancer, run by Centre Oscar Lambret at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Skin toxicities (time frame: until week 38). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2026.