Head and Neck Squamous Cell CarcinomaART-ORLNCT02024035
Protocole Advanced RadioTherapy ORL
An observational study of Head and Neck Squamous Cell Carcinoma, run by Centre Leon Berard at 14 sites in France.
Trial summary
The purpose of this study is to do health economic evaluation of tomotherapy and dynamic arctherapy (2 techniques exist: RapidArc and Vmat). This study evaluate also local disease control after 18 months in patients with an ENT epidermoid carcinoma and treated by tomotherapy orarctherapy . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 14 sitesFrance
- Study dates
- Nov 2009to Nov 2013
- 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 Cavum Epidermoïd or undifferentiated carcinoma; or oropharynx epidermoïd carcinoma; or oral cavity epidermoïd carcinoma
Who may be able to join
- PS <= 2
- Age >= 18 years
- Histologically proven carcinoma
- Cavum Epidermoïd or undifferentiated carcinoma; or oropharynx epidermoïd carcinoma; or oral cavity epidermoïd carcinoma
- Stade T1 to T4
- M0
Show all 9Show fewer
- Patient with no surgery ( except laser partial surgery and ganglionic cleaning out)
- Bilateral ganlionic cervical area irradiation
- Covered by a medical insurance.
Who cannot join
- Prior history of other malignancies in the last 5 years(except non evolutive ENT cancer or squamous cell carcinoma )
- Re-irradiation indication
- Unilateral cervical area irradiation
- Post-operative radiotherapy
- Patient treated by amifostine
- Impossible follow-up
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
Institut Sainte Catherine
Avignon, 84000
Institut BERGONIE
Bordeaux, 33076
Centre Oscar Lambret
Lille, 5900
Centre Léon Bérard
Lyon, 69008
Centre Privé de Radiothérapie de Metz
Metz, 57072
Centre Val d'Aurelle
Montpellier, 34298
Centre Alexis Vautrin
Nancy, 54511
Intitut Curie
Paris, 75005
Hôpital Eurppéen Geoges POMPIDOU
Paris, 75015
Centre Eugène Marquis
Rennes, 35042
Centre René GAUDUCHEAU
Saint-Herblain, 44800
Centre Paul STRAUSS
Strasbourg, 67085
Groupe Oncorad Garonne
Toulouse, 31300
Institut Claudius Regaud
Toulouse, 31400
About this study
Official title: Health Economic Evaluation of Tomotherapy and Dynamic Arctherapy in ENT Epidermoid Carcinoma
The purpose of this study is to do health economic evaluation of tomotherapy and dynamic arctherapy (2 techniques exist: RapidArc and Vmat).
This study evaluate also local disease control after 18 months in patients with an ENT epidermoid carcinoma and treated by tomotherapy orarctherapy .
The number of patients required in this study is: 300:
- Number of patients treated with tomotherapy: 120
- Number of patients treated with dynamic arctherapy RapidArc: 120
- Number of patients treated with dynamic arctherapy Vmat: 60
This is a prospective; multicentric and non randomized study.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Radiotherapy
- Keywords
- Tomotherapy, Head and neck squamous celle carcinoma, Health economic evaluation
- Medical subject headings
- 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.
RadiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Tomotherapy | Not described Receives: Radiation: Radiotherapy | |
| Arc'therapy Vmat | Not described Receives: Radiation: Radiotherapy | |
| Arctherapy Rapid'Arc | Not described Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The various of cost between tomotherapy and Intensity Modulation Radiation Therapy (IMRT)
The purpose of this study is to realise a Health economic evaluation of the various cost between tomotherapy and Intensity Modulation Radiation Therapy (IMRT)
Measured: 18 months
Secondary outcomes (4)
The economic impact of the learning curve of the tomotherapy process, the operating procedures and the activity of the centres
To estimate the economic impact of the learning curve of the tomotherapy process, the operating procedures and the activity of the centres
Measured: 18 months
To determine the difference of cost for the preparation phase and the irradiation phase of the radiotherapy procedure
One of the secondary objectives for the economic evaluation is to individualize the difference of cost for the preparation phase and the irradiation phase of the radiotherapy procedure
Measured: 18 months
The salivary toxicity
The salivary function will be assessed at baeline; 6; 12 and 18 months post treatment.
This evaluation will be done with differents scale (RTOG, EVA); and with salivary scan.
Measured: at 6; 12 and 18 months post treatment
To determine the rate of disease local control
Assement of disease by clinical exam and/or imaging.
Measured: Baseline, Month 6; Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startNov 2009
- Primary completionMar 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- The Biostatistics and Therapy Evaluation Unit
- Responsible party
- Sponsor
- Investigators
- Philippe GIRAUD, PhD, Principal investigator, Hopital Europeen Georges Pompidou, Paris; FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024035
- Sponsor's protocol ID
- ART-ORL
- Other IDs
- ET 2009-044
- Acronym
- ART-ORL
- Status last verified
- Dec 2013
- First submitted
- 16 Aug 2011
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bibault JE, Dussart S, Pommier P, Morelle M, Huguet M, Boisselier P, Coche-Dequeant B, Alfonsi M, Bardet E, Rives M, Calugaru V, Chajon E, Noel G, Mecellem H, Servagi Vernat S, Perrier L, Giraud P. Clinical Outcomes of Several IMRT Techniques for Patients With Head and Neck Cancer: A Propensity Score-Weighted Analysis. Int J Radiat Oncol Biol Phys. 2017 Nov 15;99(4):929-937. doi: 10.1016/j.ijrobp.2017.06.2456. Epub 2017 Jun 27.
PubMed 28864403Bibault JE, Morelle M, Perrier L, Pommier P, Boisselier P, Coche-Dequeant B, Gallocher O, Alfonsi M, Bardet E, Rives M, Calugaru V, Chajon E, Noel G, Mecellem H, Perol D, Dussart S, Giraud P. Toxicity and efficacy of cetuximab associated with several modalities of IMRT for locally advanced head and neck cancer. Cancer Radiother. 2016 Jul;20(5):357-61. doi: 10.1016/j.canrad.2016.05.009. Epub 2016 Jun 23.
PubMed 27345843
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Economic Evaluation of Tomotherapy and Dynamic Arctherapy in ENT Epidermoid Carcinoma
- ClinicalTrials.gov ID
- NCT02024035
- Acronym / sponsor ID
- ART-ORL / ART-ORL
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Tomotherapy, Head and neck squamous celle carcinoma, Health economic evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- The Biostatistics and Therapy Evaluation Unit
- Study start
- Nov 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 31 Dec 2013 (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.
The purpose of this study is to do health economic evaluation of tomotherapy and dynamic arctherapy (2 techniques exist: RapidArc and Vmat).
This study evaluate also local disease control after 18 months in patients with an ENT epidermoid carcinoma and treated by tomotherapy orarctherapy .
The number of patients required in this study is: 300:
- Number of patients treated with tomotherapy: 120
- Number of patients treated with dynamic arctherapy RapidArc: 120
- Number of patients treated with dynamic arctherapy Vmat: 60
This is a prospective; multicentric and non randomized study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tomotherapy | – | Radiation: Radiotherapy |
| Arc'therapy Vmat | – | Radiation: Radiotherapy |
| Arctherapy Rapid'Arc | – | Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Cavum Epidermoïd or undifferentiated carcinoma; or oropharynx epidermoïd carcinoma; or oral cavity epidermoïd carcinoma
Key inclusion criteria (9 listed)
- PS <= 2
- Age >= 18 years
- Histologically proven carcinoma
- Cavum Epidermoïd or undifferentiated carcinoma; or oropharynx epidermoïd carcinoma; or oral cavity epidermoïd carcinoma
- Stade T1 to T4
Key exclusion criteria (6 listed)
- Prior history of other malignancies in the last 5 years(except non evolutive ENT cancer or squamous cell carcinoma )
- Re-irradiation indication
- Unilateral cervical area irradiation
- Post-operative radiotherapy
- Patient treated by amifostine
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 |
|---|---|---|
| Radiotherapy | Radiation | Arc'therapy Vmat, Arctherapy Rapid'Arc, Tomotherapy |
Primary outcome
The various of cost between tomotherapy and Intensity Modulation Radiation Therapy (IMRT)
Time frame: 18 months
The purpose of this study is to realise a Health economic evaluation of the various cost between tomotherapy and Intensity Modulation Radiation Therapy (IMRT)
4 secondary outcomes
The economic impact of the learning curve of the tomotherapy process, the operating procedures and the activity of the centres
Time frame: 18 months
To determine the difference of cost for the preparation phase and the irradiation phase of the radiotherapy procedure
Time frame: 18 months
The salivary toxicity
Time frame: at 6; 12 and 18 months post treatment
To determine the rate of disease local control
Time frame: Baseline, Month 6; Month 18
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 31 Dec 2013.
- Derived from this study: PubMed 28864403Bibault JE, Dussart S, Pommier P, Morelle M, Huguet M, Boisselier P, Coche-Dequeant B, Alfonsi M, Bardet E, Rives M, Calugaru V, Chajon E, Noel G, Mecellem H, Servagi Vernat S, Perrier L, Giraud P. Clinical Outcomes of Several IMRT Techniques for Patients With Head and Neck Cancer: A Propensity Score-Weighted Analysis. Int J Radiat Oncol Biol Phys. 2017 Nov 15;99(4):929-937. doi: 10.1016/j.ijrobp.2017.06.2456. Epub 2017 Jun 27.
- Derived from this study: PubMed 27345843Bibault JE, Morelle M, Perrier L, Pommier P, Boisselier P, Coche-Dequeant B, Gallocher O, Alfonsi M, Bardet E, Rives M, Calugaru V, Chajon E, Noel G, Mecellem H, Perol D, Dussart S, Giraud P. Toxicity and efficacy of cetuximab associated with several modalities of IMRT for locally advanced head and neck cancer. Cancer Radiother. 2016 Jul;20(5):357-61. doi: 10.1016/j.canrad.2016.05.009. Epub 2016 Jun 23.
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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 GIRAUD, PhD principal investigator
Hopital Europeen Georges Pompidou, Paris; FRANCE
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Squamous Cell Carcinoma, run by Centre Leon Berard at 14 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 9 inclusion and 6 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 31 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
The various of cost between tomotherapy and Intensity Modulation Radiation Therapy (IMRT) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02024035, which also lists 2 linked publications.
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 31 Dec 2013.