Contribution of the ENT (Ear, Nose, and Throat) Surgeon's Clinical Evaluation to the Contouring of Target Volumes and Organs Eligible for Radiotherapy in Head and Neck Cancers

Head and Neck Cancer Clinical Trial

— CONTOUR  

Official title:

Contribution of the ENT Surgeon's Clinical Evaluation to the Contouring of Target Volumes and Organs Eligible for Radiotherapy in Head and Neck Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265873
• Other study ID #: DBU_2017_13
• Status: Completed
• Start date: November 28, 2017
• Est. completion date: October 13, 2023

Study information

• Verified date: October 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Radiotherapy (RT), surgery and chemotherapy (CT) are treatments for head and neck cancers, used alone or in combination. Conformal RT with Intensity Modulation (IMRT) is currently the reference technique. IMRT requires a precise definition of the target volumes to be treated and the anatomical structures to be protected from irradiation. Most studies of head and neck cancers published in the literature demonstrate the variability in the contouring of the target volumes between radiotherapists. This may have an impact on dosimetry. To date, no studies have evaluated the impact of the ENT surgeon's evaluation in volumes contouring. The aim of this study is to compare the volumes determined by the radiotherapists alone and those determined jointly by the radiotherapists and the ENT surgeon.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 13, 2023
• Est. primary completion date: October 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years;
• Cancer of the upper aerodigestive tract (oral cavity, oropharynx, larynx, hypopharynx, rhinopharynx, salivary glands, facial sinuses, orbital cavity, ear);
• Cancer confirmed by histopathological analysis;
• Therapeutic protocol including radiotherapy.

Exclusion Criteria:

• Any history of radiotherapy of the head and neck
• Synchronous head and neck cancer.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Otolaryngology
• Radiation Oncologists
• Radiotherapy, Conformal (IMRT)
• Surgeons

Intervention

Other:
• Systematic consideration of the advice of the ENT surgeon in the determination of the radiotherapy target volumes in head and neck cancers.
The contouring of the different target volumes will be first performed by the radiotherapists. During the Head and Neck Tumor Board, the volumes initially determined by the radiotherapists will be analyzed jointly by the radiotherapists and the patient's ENT surgeon to carry out, if necessary, modifications, taking into account clinical observations, intraoperative findings (if any) and endoscopy findings. Concordance parameters will be calculated in a second time with the determined volumes (in particular, index of concordance, coefficient of similarity).

Locations

Country	Name	City	State
France	Hôpital d'Instruction des Armées	Clamart
France	Fondation Ophtalmologique A. de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with head and neck cancer for whom a change in the CTV (Clinical Target Volume) was made following the advice of the ENT surgeon.		Baseline