A New Delineation Approach for Oral Cavity, Oropharynx, Larynx and Hypopharynx in IMRT for Head and Neck Cancer
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable head-and-neck-cancer
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2021
CompletedFirst Submitted
Initial submission to the registry
September 5, 2022
CompletedFirst Posted
Study publicly available on registry
September 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 11, 2023
CompletedMay 17, 2024
May 1, 2024
1.1 years
September 5, 2022
May 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
"Oropharyngeal mucosa" as OARs
EXPERIMENTAL"Oropharyngeal mucosa" was delineated as OARs and limiting its dose
oropharynx as OARs
EXPERIMENTALOropharynx was delineated as OARs and limiting its dose
Oropharynx and "oropharyngeal mucosa"as OARs
EXPERIMENTALOropharynx and "oropharyngeal mucosa" was delineated as OARs and limiting its dose
Interventions
"Oropharyngeal mucosa" was delineated as OARs and limiting its dose
oropharynx and "oropharyngeal mucosa"were delineated as OARs and limiting its dose
Eligibility Criteria
You may qualify if:
- \- patients with previously untreated of the head and neck cancer who received definitive IMRT at our institution
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Radiotherapy, Hebei Province Hospital of Chinese Medicine
Shijiazhuang, Hebei, 050011, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 5, 2022
First Posted
September 14, 2022
Study Start
November 11, 2021
Primary Completion
December 11, 2022
Study Completion
December 11, 2023
Last Updated
May 17, 2024
Record last verified: 2024-05