Clinical trial NCT02024035: Protocole Advanced RadioTherapy ORL
Official title: Health Economic Evaluation of Tomotherapy and Dynamic Arctherapy in ENT Epidermoid Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: Tomotherapy
Head and neck squamous celle carcinoma
Health economic evaluation
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: The Biostatistics and Therapy Evaluation Unit
First posted: 2013-12-31
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with Cavum Epidermoïd or undifferentiated carcinoma; or oropharynx epidermoïd carcinoma; or oral cavity epidermoïd carcinoma

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.


Eligibility criteria: Inclusion Criteria:

* 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
* Patient with no surgery ( except laser partial surgery and ganglionic cleaning out)
* Bilateral ganlionic cervical area irradiation
* Covered by a medical insurance.

Exclusion Criteria:

* 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

Primary outcomes:
measure: The various of cost between tomotherapy and Intensity Modulation Radiation Therapy (IMRT)
timeFrame: 18 months
Secondary outcomes:
measure: The economic impact of the learning curve of the tomotherapy process, the operating procedures and the activity of the centres
timeFrame: 18 months
measure: To determine the difference of cost for the preparation phase and the irradiation phase of the radiotherapy procedure
timeFrame: 18 months
measure: The salivary toxicity
timeFrame: at 6; 12 and 18 months post treatment
measure: To determine the rate of disease local control
timeFrame: Baseline, Month 6; Month 18
Other outcomes:
Locations:
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Bordeaux
country: France
facility: Institut BERGONIE
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Metz
country: France
facility: Centre Privé de Radiothérapie de Metz
city: Montpellier
country: France
facility: Centre Val d'Aurelle
city: Nancy
country: France
facility: Centre Alexis Vautrin
city: Paris 15
country: France
facility: Hôpital Eurppéen Geoges POMPIDOU
city: Paris
country: France
facility: Intitut Curie
city: Rennes
country: France
facility: Centre Eugène Marquis
city: St HERBLAIN
country: France
facility: Centre René GAUDUCHEAU
city: Strasbourg
country: France
facility: Centre Paul STRAUSS
city: Toulouse
country: France
facility: Groupe Oncorad Garonne
city: Toulouse
country: France
facility: Institut Claudius Regaud
Study officials:
affiliation: Hopital Europeen Georges Pompidou, Paris; FRANCE
name: Philippe GIRAUD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bibault 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.