Head and Neck CancerNCT05539144
A New Delineation Approach for Oral Cavity, Oropharynx, Larynx and Hypopharynx in IMRT for Head and Neck Cancer
A study testing "Oropharyngeal mucosa", oropharynx and oropharynx and "oropharyngeal mucosa" in people with Head and Neck Cancer and Radiotherapy, run by Hebei Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Cancer, Radiotherapy, Oropharynx Abnormality
- What is being tested?
- "Oropharyngeal mucosa", oropharynx and oropharynx and "oropharyngeal mucosa"
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2021to 11 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with previously untreated of the head and neck cancer who received definitive IMRT at our institution
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Radiotherapy, Hebei Province Hospital of Chinese Medicine
Shijiazhuang, Hebei, 050011
About this study
Official title: A New Delineation Approach for Oral Cavity, Oropharynx, Larynx and Hypopharynx in Intensity-modulated Radiation Treatment for Head and Neck Cancer
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.
Read the 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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- Being tested
- "Oropharyngeal mucosa", oropharynx, oropharynx and "oropharyngeal mucosa"
- Keywords
- Oropharynx, Dosimetric parameters, Intensity-modulated radiation treatment（IMRT）, Head and Neck Cancer, Radiotherapy
- Medical subject headings
- Head and Neck Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Oropharyngeal mucosa"Radiation
"Oropharyngeal mucosa" was delineated as OARs and limiting its dose
oropharynxRadiation
oropharynx was delineated as OARs and limiting its dose
oropharynx and "oropharyngeal mucosa"Radiation
oropharynx and "oropharyngeal mucosa"were delineated as OARs and limiting its dose
| Study group | Role | What they receive |
|---|---|---|
| "Oropharyngeal mucosa" as OARs | Experimental | "Oropharyngeal mucosa" was delineated as OARs and limiting its dose Receives: Radiation: "Oropharyngeal mucosa" |
| oropharynx as OARs | Experimental | Oropharynx was delineated as OARs and limiting its dose Receives: Radiation: oropharynx |
| Oropharynx and "oropharyngeal mucosa"as OARs | Experimental | Oropharynx and "oropharyngeal mucosa" was delineated as OARs and limiting its dose Receives: Radiation: oropharynx and "oropharyngeal mucosa" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start11 Nov 2021
- Primary completion11 Dec 2022
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xueqi Wang, Hebei Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539144
- Sponsor's protocol ID
- HebeiProvincial
- Status last verified
- May 2024
- First submitted
- 5 Sep 2022
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Delineation Approach for Oral Cavity, Oropharynx, Larynx and Hypopharynx in Intensity-modulated Radiation Treatment for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05539144
- Acronym / sponsor ID
- HebeiProvincial
- Keywords
- Oropharynx, Dosimetric parameters, Intensity-modulated radiation treatment（IMRT）, Head and Neck Cancer, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hebei Provincial Hospital of Traditional Chinese MedicineOther government
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 11 Dec 2022 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "Oropharyngeal mucosa" as OARs | Experimental | Radiation: "Oropharyngeal mucosa""Oropharyngeal mucosa" was delineated as OARs and limiting its dose |
| oropharynx as OARs | Experimental | Radiation: oropharynxOropharynx was delineated as OARs and limiting its dose |
| Oropharynx and "oropharyngeal mucosa"as OARs | Experimental | Radiation: oropharynx and "oropharyngeal mucosa"Oropharynx and "oropharyngeal mucosa" was delineated as OARs and limiting its dose |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with previously untreated of the head and neck cancer who received definitive IMRT at our institution
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Oropharyngeal mucosa""Oropharyngeal mucosa" was delineated as OARs and limiting its dose | Radiation | "Oropharyngeal mucosa" as OARs |
| oropharynxoropharynx was delineated as OARs and limiting its dose | Radiation | oropharynx as OARs |
| oropharynx and "oropharyngeal mucosa"oropharynx and "oropharyngeal mucosa"were delineated as OARs and limiting its dose | Radiation | Oropharynx and "oropharyngeal mucosa"as OARs |
Primary outcome
Dose distribution
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Oropharyngeal mucosa", oropharynx and oropharynx and "oropharyngeal mucosa" in people with Head and Neck Cancer and Radiotherapy, run by Hebei Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose distribution (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.