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

Not Applicable

Completed

• Conditions: Head and Neck Cancer; Radiotherapy; Adverse Effect; Radiotherapy; Oropharynx Abnormality
• Interventions: Radiation: oropharynx; Radiation: "Oropharyngeal mucosa"; Radiation: oropharynx and "oropharyngeal mucosa"

• Registration Number: NCT05539144
• Lead Sponsor: Hebei Provincial Hospital of Traditional Chinese Medicine

Brief 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.

Detailed 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.

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Study Timeline

• Study Start: 2021-11-11
• Study First Submitted: 2022-09-05
• Study First Submitted QC: 2022-09-09
• Study First Posted: 2022-09-14
• Primary Completion: 2022-12-11
• Study Completion: 2023-12-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• patients with previously untreated of the head and neck cancer who received definitive IMRT at our institution

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oropharynx as OARs	oropharynx	Oropharynx was delineated as OARs and limiting its dose
"Oropharyngeal mucosa" as OARs	"Oropharyngeal mucosa"	"Oropharyngeal mucosa" was delineated as OARs and limiting its dose
Oropharynx and "oropharyngeal mucosa"as OARs	oropharynx and "oropharyngeal mucosa"	Oropharynx and "oropharyngeal mucosa" was delineated as OARs and limiting its dose

Primary Outcome Measures

Name	Time	Method
Dose distribution	through study completion, an average of 1 year	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.

Trial Locations

Locations (1)

Department of Radiotherapy, Hebei Province Hospital of Chinese Medicine; 🇨🇳 Shijiazhuang, Hebei, China