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NCT05539144 Clinical Trial

A New Delineation Approach for Oral Cavity, Oropharynx, Larynx and Hypopharynx in IMRT for Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:
A New Delineation Approach for Oral Cavity, Oropharynx, Larynx and Hypopharynx in Intensity-modulated Radiation Treatment for Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05539144
Other study ID # HebeiProvincial
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 11, 2021
Est. completion date December 11, 2023

Study information
Verified date May 2024
Source Hebei Provincial Hospital of Traditional Chinese Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators tries a new method to delineating the oral cavity, oropharynx, larynx and hypopharynx, and use the head-and-neck region to test whether the method can to create a good IMRT plan, and alleviate the oral radiation injury, reduce the incidence of adverse reactions.

Description:

Purpose: To assess the dosimetric effect of new delineation approach for oral cavity, oropharynx, larynx and hypopharynx in intensity-modulated radiotherapy(IMRT) treatment planning for head and neck cancer. Methods: Twenty head and neck cancer patients were treated by IMRT. Target volumes and several organs at risk were delineated with Corvus6．3 treatment planning system. An investigative IMRT plan was generated based on a standard treatment planning protocol, but used a new delineation approach for oral cavity, oropharynx, larynx and hypopharynx. Plans were exported to treatment planning system for quantitative analysis of dose volume parameters. Variables assessed included: maximum oral cavity, oropharynx, larynx and hypopharynx dose, equivalent uniform dose of the oral cavity, oropharynx, larynx and hypopharynx (EUD), mean oral cavity, oropharynx, larynx and hypopharynx dose, mean organs at risks (OARs) doses, and dose homogeneity inside the target volumes. .

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date December 11, 2023
Est. primary completion date December 11, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - patients with previously untreated of the head and neck cancer who received definitive IMRT at our institution Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• "Oropharyngeal mucosa"
"Oropharyngeal mucosa" was delineated as OARs and limiting its dose
• oropharynx
oropharynx was delineated as OARs and limiting its dose
• oropharynx and "oropharyngeal mucosa"
oropharynx and "oropharyngeal mucosa"were delineated as OARs and limiting its dose

Locations
Country Name City State
China Department of Radiotherapy, Hebei Province Hospital of Chinese Medicine Shijiazhuang Hebei

Sponsors (1)
Lead Sponsor Collaborator
Hebei Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dose distribution maximum oral cavity, oropharynx, larynx and hypopharynx dose, equivalent uniform dose of the oral cavity, oropharynx, larynx and hypopharynx (EUD), mean oral cavity, oropharynx, larynx and hypopharynx dose, mean organs at risks (OARs) doses, and dose homogeneity inside the target volumes. through study completion, an average of 1 year
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