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Clinical Trials/NCT03265873
NCT03265873CompletedNot Applicable

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

Fondation Ophtalmologique Adolphe de Rothschild2 sites in 1 country100 target enrollmentStarted: November 28, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
2
Primary Endpoint
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.

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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.

Outcomes

Primary Outcomes

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.

Time Frame: Baseline

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (2)

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