Back to resultsA New Delineation Approach for Oral Cavity, Oropharynx, Larynx and Hypopharynx in IMRT for Head and Neck Cancer
Primary Purpose
Head and Neck Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Delineation for organs at risks (OARs) in IMRT plan
Sponsored by
About this trial
This is an interventional prevention trial for Head and Neck Cancer
Eligibility Criteria
Inclusion Criteria:
- patients with previously untreated of the head and neck cancer who received definitive IMRT at our institution
Exclusion Criteria:
-
Sites / Locations
- Department of Radiotherapy, Hebei Province Hospital of Chinese Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
new delineation approach for oral cavity, oropharynx, larynx and hypopharynx.
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05539144
First Posted
September 5, 2022
Last Updated
September 9, 2022
Sponsor
Hebei Provincial Hospital of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05539144
Brief Title
A New Delineation Approach for Oral Cavity, Oropharynx, Larynx and Hypopharynx in IMRT for Head and Neck Cancer
Official Title
A New Delineation Approach for Oral Cavity, Oropharynx, Larynx and Hypopharynx in Intensity-modulated Radiation Treatment for Head and Neck Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 11, 2022 (Anticipated)
Primary Completion Date
October 11, 2023 (Anticipated)
Study Completion Date
December 11, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebei Provincial Hospital of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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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6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
new delineation approach for oral cavity, oropharynx, larynx and hypopharynx.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Delineation for organs at risks (OARs) in IMRT plan
Intervention Description
An adaptive contouring brush within the planning software was used to create a new structure: the air cavity within oral cavity, oropharynx, larynx and hypopharynx, and the new structure was expanded and shrunk uniformly 2 mm to create the oral cavity, oropharynx, larynx and hypopharynx
Primary Outcome Measure Information:
Title
Dose distribution
Description
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.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- patients with previously untreated of the head and neck cancer who received definitive IMRT at our institution
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xueqi Wang, Ms
Phone
18231112781
Ext
0086
Email
1748768622@qq.com
Facility Information:
Facility Name
Department of Radiotherapy, Hebei Province Hospital of Chinese Medicine
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China
12. IPD Sharing Statement
Learn more about this trial
A New Delineation Approach for Oral Cavity, Oropharynx, Larynx and Hypopharynx in IMRT for Head and Neck Cancer
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