NCT05539144

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2023

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

September 5, 2022

Last Update Submit

May 15, 2024

Conditions

Keywords

OropharynxDosimetric parametersIntensity-modulated radiation treatment(IMRT)Head and Neck CancerRadiotherapy

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

Radiation: "Oropharyngeal mucosa"

oropharynx as OARs

EXPERIMENTAL

Oropharynx was delineated as OARs and limiting its dose

Radiation: oropharynx

Oropharynx and "oropharyngeal mucosa"as OARs

EXPERIMENTAL

Oropharynx and "oropharyngeal mucosa" was delineated as OARs and limiting its dose

Radiation: oropharynx and "oropharyngeal mucosa"

Interventions

"Oropharyngeal mucosa" was delineated as OARs and limiting its dose

"Oropharyngeal mucosa" as OARs
oropharynxRADIATION

oropharynx was delineated as OARs and limiting its dose

oropharynx as OARs

oropharynx and "oropharyngeal mucosa"were delineated as OARs and limiting its dose

Oropharynx and "oropharyngeal mucosa"as OARs

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsRadiation Injuries

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsWounds and Injuries

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

Locations