Protocole Advanced RadioTherapy ORL
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Interventions
- Radiation: Radiotherapy
- Registration Number
- NCT02024035
- Lead Sponsor
- Centre Leon Berard
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- 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.
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arctherapy Rapid'Arc Radiotherapy - Tomotherapy Radiotherapy - Arc'therapy Vmat Radiotherapy -
- Primary Outcome Measures
Name Time Method The various of cost between tomotherapy and Intensity Modulation Radiation Therapy (IMRT) 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)
- Secondary Outcome Measures
Name Time Method To determine the rate of disease local control Baseline, Month 6; Month 18 Assement of disease by clinical exam and/or imaging.
The economic impact of the learning curve of the tomotherapy process, the operating procedures and the activity of the centres 18 months To estimate the economic impact of the learning curve of the tomotherapy process, the operating procedures and the activity of the centres
To determine the difference of cost for the preparation phase and the irradiation phase of the radiotherapy procedure 18 months 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
The salivary toxicity at 6; 12 and 18 months post treatment 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.
Trial Locations
- Locations (14)
Intitut Curie
🇫🇷Paris, France
Institut BERGONIE
🇫🇷Bordeaux, France
Groupe Oncorad Garonne
🇫🇷Toulouse, France
Centre Val d'Aurelle
🇫🇷Montpellier, France
Centre Oscar Lambret
🇫🇷Lille, France
Centre Alexis Vautrin
🇫🇷Nancy, France
Centre Eugène Marquis
🇫🇷Rennes, France
Centre Léon Bérard
🇫🇷Lyon, France
Institut Sainte Catherine
🇫🇷Avignon, France
Hôpital Eurppéen Geoges POMPIDOU
🇫🇷Paris 15, France
Centre Privé de Radiothérapie de Metz
🇫🇷Metz, France
Centre René GAUDUCHEAU
🇫🇷St HERBLAIN, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Centre Paul STRAUSS
🇫🇷Strasbourg, France