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

NCT03265873 | Completed

• 1 other identifier: DBU_2017_13
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Systematic consideration of the advice of the ENT surgeon in the determination of the radiotherapy target volumes in head and neck cancers. OTHER

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with head and neck cancer who require radiotherapy.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (2)

Hôpital d'Instruction des Armées

Clamart, 92140, France

Location

Fondation Ophtalmologique A. de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Philippe Clément, MD

  Hôpital d'Instruction des armées Percy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: August 29, 2017
• Study Start: November 28, 2017
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

FR (2)