CONTOUR: 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

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03265873
• Collaborator: (none)
• Enrollment: 100
• Locations: 2
• Anticipated Duration (Months): 77.1
• Patients Per Site: 50
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radiotherapy, Conformal (IMRT); Head and Neck Cancer; Otolaryngology; Surgeons; Radiation Oncologists	Other: Systematic consideration of the advice of the ENT surgeon in the determination of the radiotherapy target volumes in head and neck cancers.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• 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
• Actual Study Start Date: Nov 28, 2017
• Anticipated Primary Completion Date: Nov 1, 2023
• Anticipated Study Completion Date: May 1, 2024

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital d'Instruction des Armées	Clamart		France	92140
2	Fondation Ophtalmologique A. de Rothschild	Paris		France	75019

Sponsors and Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild

Investigators

• Principal Investigator: Philippe Clément, MD, Hôpital d'Instruction des armées Percy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
• ClinicalTrials.gov Identifier: NCT03265873
• Other Study ID Numbers: DBU_2017_13
• First Posted: Aug 29, 2017
• Last Update Posted: Sep 17, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Head and Neck Neoplasms

Study Results

No Results Posted as of Sep 17, 2021