Protocole Advanced RadioTherapy ORL
ART-ORL
Health Economic Evaluation of Tomotherapy and Dynamic Arctherapy in ENT Epidermoid Carcinoma
2 other identifiers
observational
180
1 country
14
Brief 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 . 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2009
Longer than P75 for all trials
14 active sites
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
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedFirst Posted
Study publicly available on registry
December 31, 2013
CompletedDecember 31, 2013
December 1, 2013
2.3 years
August 16, 2011
December 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
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
18 months
To determine the difference of cost for the preparation phase and the irradiation phase of the radiotherapy procedure
18 months
The salivary toxicity
at 6; 12 and 18 months post treatment
To determine the rate of disease local control
Baseline, Month 6; Month 18
Study Arms (3)
Tomotherapy
Arc'therapy Vmat
Arctherapy Rapid'Arc
Interventions
Eligibility Criteria
Patient with Cavum Epidermoïd or undifferentiated carcinoma; or oropharynx epidermoïd carcinoma; or oral cavity epidermoïd carcinoma
You may qualify if:
- 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
- Patient with no surgery ( except laser partial surgery and ganglionic cleaning out)
- Bilateral ganlionic cervical area irradiation
- Covered by a medical insurance.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Leon Berardlead
- The Biostatistics and Therapy Evaluation Unitcollaborator
Study Sites (14)
Institut Sainte Catherine
Avignon, 84000, France
Institut BERGONIE
Bordeaux, 33076, France
Centre Oscar Lambret
Lille, 5900, France
Centre Léon Bérard
Lyon, 69008, France
Centre Privé de Radiothérapie de Metz
Metz, 57072, France
Centre Val d'Aurelle
Montpellier, 34298, France
Centre Alexis Vautrin
Nancy, 54511, France
Intitut Curie
Paris, 75005, France
Hôpital Eurppéen Geoges POMPIDOU
Paris, 75015, France
Centre Eugène Marquis
Rennes, 35042, France
Centre René GAUDUCHEAU
Saint-Herblain, 44800, France
Centre Paul STRAUSS
Strasbourg, 67085, France
Groupe Oncorad Garonne
Toulouse, 31300, France
Institut Claudius Regaud
Toulouse, 31400, France
Related Publications (2)
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.
PMID: 28864403DERIVEDBibault 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.
PMID: 27345843DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe GIRAUD, PhD
Hopital Europeen Georges Pompidou, Paris; FRANCE
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2011
First Posted
December 31, 2013
Study Start
November 1, 2009
Primary Completion
March 1, 2012
Study Completion
November 1, 2013
Last Updated
December 31, 2013
Record last verified: 2013-12