Protocole Advanced RadioTherapy ORL

Study Overview
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Brief Summary
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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.

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

Conditions
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Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tomotherapy<br> | Radiation: Radiotherapy<br> <br> |
| Arc'therapy Vmat<br> | Radiation: Radiotherapy<br> <br> |
| Arctherapy Rapid'Arc<br> | Radiation: Radiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| To determine the rate of disease local control | Assement of disease by clinical exam and/or imaging. | Baseline, Month 6; Month 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tomotherapy, Head and neck squamous celle carcinoma, Health economic evaluation