Protocole Advanced RadioTherapy ORL

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02024035

Acronym

ART-ORL

Enrollment

180

Registered

2013-12-31

Start date

2009-11-30

Completion date

2013-11-30

Last updated

2013-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Tomotherapy, Head and neck squamous celle carcinoma, Health economic evaluation

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.

Interventions

RADIATIONRadiotherapy

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026