Protocole Advanced RadioTherapy ORL

Head and Neck Squamous Cell Carcinoma Clinical Trial

— ART-ORL  

Official title:

Health Economic Evaluation of Tomotherapy and Dynamic Arctherapy in ENT Epidermoid Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02024035
• Other study ID #: ART-ORL
• Secondary ID: ET 2009-044
• Status: Completed
• Phase: N/A
• First received: August 16, 2011
• Last updated: December 23, 2013
• Start date: November 2009
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Committee for the Protection of Personnes
• Study type: Observational

Clinical 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma

Intervention

Radiation:
• Radiotherapy

Locations

Country	Name	City	State
France	Institut Sainte Catherine	Avignon
France	Institut BERGONIE	Bordeaux
France	Centre Oscar Lambret	Lille
France	Centre Léon Bérard	Lyon
France	Centre Privé de Radiothérapie de Metz	Metz
France	Centre Val d'Aurelle	Montpellier
France	Centre Alexis Vautrin	Nancy
France	Intitut Curie	Paris
France	Hôpital Eurppéen Geoges POMPIDOU	Paris 15
France	Centre Eugène Marquis	Rennes
France	Centre René GAUDUCHEAU	St HERBLAIN
France	Centre Paul STRAUSS	Strasbourg
France	Groupe Oncorad Garonne	Toulouse
France	Institut Claudius Regaud	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Centre Leon Berard	The Biostatistics and Therapy Evaluation Unit

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	18 months	No
Secondary	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	18 months	No
Secondary	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.	at 6; 12 and 18 months post treatment	No
Secondary	To determine the rate of disease local control	Assement of disease by clinical exam and/or imaging.	Baseline, Month 6; Month 18	No