Skip to main content
OpenTrials
Completed

NCT Number: NCT02024035

Protocole Advanced RadioTherapy ORL

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Sainte Catherine, Avignon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy

Radiation

Primary outcomes

  1. The various of cost between tomotherapy and Intensity Modulation Radiation Therapy (IMRT)

    Time frame: 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 outcomes

  1. 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 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

    Time frame: 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

    Time frame: 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

    Time frame: Baseline, Month 6; Month 18

    Assement of disease by clinical exam and/or imaging.

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Collaborators

  • The Biostatistics and Therapy Evaluation Unit

Registry information

Official study title

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

Acronym: ART-ORL

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Dec 31, 2013
Registry last updated
Dec 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.