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| ID | Type | Description | Link |
|---|---|---|---|
| ET 2009-044 |
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| Name | Class |
|---|---|
| The Biostatistics and Therapy Evaluation Unit | OTHER |
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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:
This is a prospective; multicentric and non randomized study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tomotherapy |
| ||
| Arc'therapy Vmat |
| ||
| Arctherapy Rapid'Arc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with Cavum Epidermoïd or undifferentiated carcinoma; or oropharynx epidermoïd carcinoma; or oral cavity epidermoïd carcinoma
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| Name | Affiliation | Role |
|---|---|---|
| Philippe GIRAUD, PhD | Hopital Europeen Georges Pompidou, Paris; FRANCE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Sainte Catherine | Avignon | 84000 | France | |||
| Institut BERGONIE |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28864403 | Derived | Bibault JE, Dussart S, Pommier P, Morelle M, Huguet M, Boisselier P, Coche-Dequeant B, Alfonsi M, Bardet E, Rives M, Calugaru V, Chajon E, Noel G, Mecellem H, Servagi Vernat S, Perrier L, Giraud P. Clinical Outcomes of Several IMRT Techniques for Patients With Head and Neck Cancer: A Propensity Score-Weighted Analysis. Int J Radiat Oncol Biol Phys. 2017 Nov 15;99(4):929-937. doi: 10.1016/j.ijrobp.2017.06.2456. Epub 2017 Jun 27. | |
| 27345843 |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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 |
| Bordeaux |
| 33076 |
| France |
| Centre Oscar Lambret | Lille | 5900 | France |
| Centre Léon Bérard | Lyon | 69008 | France |
| Centre Privé de Radiothérapie de Metz | Metz | 57072 | France |
| Centre Val d'Aurelle | Montpellier | 34298 | France |
| Centre Alexis Vautrin | Nancy | 54511 | France |
| Intitut Curie | Paris | 75005 | France |
| Hôpital Eurppéen Geoges POMPIDOU | Paris | 75015 | France |
| Centre Eugène Marquis | Rennes | 35042 | France |
| Centre René GAUDUCHEAU | Saint-Herblain | 44800 | France |
| Centre Paul STRAUSS | Strasbourg | 67085 | France |
| Groupe Oncorad Garonne | Toulouse | 31300 | France |
| Institut Claudius Regaud | Toulouse | 31400 | France |
| Derived |
| Bibault JE, Morelle M, Perrier L, Pommier P, Boisselier P, Coche-Dequeant B, Gallocher O, Alfonsi M, Bardet E, Rives M, Calugaru V, Chajon E, Noel G, Mecellem H, Perol D, Dussart S, Giraud P. Toxicity and efficacy of cetuximab associated with several modalities of IMRT for locally advanced head and neck cancer. Cancer Radiother. 2016 Jul;20(5):357-61. doi: 10.1016/j.canrad.2016.05.009. Epub 2016 Jun 23. |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |