Protocole Advanced RadioTherapy ORL (ART-ORL)

Léon Bérard Center

Status: Completed

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Radiation: Radiotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT02024035

ART-ORL

ET 2009-044

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

180 participants in 3 patient groups

Tomotherapy

Treatment:

Radiation: Radiotherapy

Arc'therapy Vmat

Treatment:

Radiation: Radiotherapy

Arctherapy Rapid'Arc

Treatment:

Radiation: Radiotherapy