Protocole Advanced RadioTherapy ORL

N/ACompletedNCT02024035

Centre Leon Berard180 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

180

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

RadiotherapyRADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (14)

Institut Sainte Catherine

Avignon, France

Institut BERGONIE

Bordeaux, France

Centre Oscar Lambret

Lille, France

Outcomes

Primary Outcomes

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)

Time frame: 18 months

Secondary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: Baseline, Month 6; Month 18

Data from ClinicalTrials.gov

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