ART-ORL: Protocole Advanced RadioTherapy ORL

• Sponsor: Centre Leon Berard (Other)
• Overall Status: Completed
• CT.gov ID: NCT02024035
• Collaborator: The Biostatistics and Therapy Evaluation Unit (Other)
• Enrollment: 180
• Locations: 14
• Duration (Months): 48
• Patients Per Site: 12.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Squamous Cell Carcinoma	Radiation: Radiotherapy

Study Design

• Study Type: Observational
• Actual Enrollment: 180 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Health Economic Evaluation of Tomotherapy and Dynamic Arctherapy in ENT Epidermoid Carcinoma
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Tomotherapy	Radiation: Radiotherapy
Arc'therapy Vmat	Radiation: Radiotherapy
Arctherapy Rapid'Arc	Radiation: Radiotherapy

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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.

4. To determine the rate of disease local control [Baseline, Month 6; Month 18]

   Assement of disease by clinical exam and/or imaging.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Sainte Catherine	Avignon		France	84000
2	Institut BERGONIE	Bordeaux		France	33076
3	Centre Oscar Lambret	Lille		France	5900
4	Centre Léon Bérard	Lyon		France	69008
5	Centre Privé de Radiothérapie de Metz	Metz		France	57072
6	Centre Val d'Aurelle	Montpellier		France	34298
7	Centre Alexis Vautrin	Nancy		France	54511
8	Hôpital Eurppéen Geoges POMPIDOU	Paris 15		France	75015
9	Intitut Curie	Paris		France	75005
10	Centre Eugène Marquis	Rennes		France	35042
11	Centre René GAUDUCHEAU	St HERBLAIN		France	44800
12	Centre Paul STRAUSS	Strasbourg		France	67085
13	Groupe Oncorad Garonne	Toulouse		France	31300
14	Institut Claudius Regaud	Toulouse		France	31400

Sponsors and Collaborators

• Centre Leon Berard
• The Biostatistics and Therapy Evaluation Unit

Investigators

• Principal Investigator: Philippe GIRAUD, PhD, Hopital Europeen Georges Pompidou, Paris; FRANCE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Leon Berard
• ClinicalTrials.gov Identifier: NCT02024035
• Other Study ID Numbers: ART-ORL; ET 2009-044
• First Posted: Dec 31, 2013
• Last Update Posted: Dec 31, 2013
• Last Verified: Dec 1, 2013

• Keywords provided by Centre Leon Berard: Tomotherapy; Head and neck squamous celle carcinoma; Health economic evaluation
• Additional relevant MeSH terms: Carcinoma; Squamous Cell Carcinoma of Head and Neck

Study Results

No Results Posted as of Dec 31, 2013