Nasopharyngeal CarcinomaNCT06268600
The Protection of Thyroid Function in IMRT for Nasopharyngeal Carcinoma
A study testing Modified neck target volume delineation in people with Nasopharyngeal Carcinoma and Nasopharyngeal Cancer, run by Jiangxi Provincial Cancer Hospital at 1 site in China.
Trial summary
This study aimed to reduce radiation-induced thyroid injury without compromising control of the cervical region by optimizing the delineation of the cervical lymph node drainage area. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, Nasopharyngeal Cancer, Hypothyroidism
- What is being tested?
- Modified neck target volume delineation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Nov 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The pathological diagnosis was newly diagnosed non-keratinizing squamous cell carcinoma nasopharyngeal carcinoma.
- The clinical stage is T1-4N0-3M0 (stage I~IVa, UICC/AJCC 8th edition);
- There is no history of hypothyroidism or hyperthyroidism before treatment;
- Using intensity-modulated radiotherapy technology,
- Complete radical dose radiotherapy;
- KPS≥70 points;
Show all 12Show fewer
- Age 18-70 years old;
- Male or female who is not pregnant or lactating;
- Hematological examination: white blood cells > 4×109/L, neutrophils > 2×109/L, hemoglobin > 90g/L, platelets > 100×109/L;
- Liver function: ALT, AST < 1.5×ULN, ALP < 2.5×ULN, bilirubin < ULN.
- Renal function: creatinine > 60 ml/min;
- The patient signs the informed consent form;
Who cannot join
- WHO pathological classification is keratinizing squamous cell carcinoma or basaloid carcinoma;
- palliative treatment;
- Have a history of other malignant tumors;
- Pregnant or lactating women (women of childbearing age should consider taking a pregnancy test, and patients are required to use effective contraception during treatment);
- Have a history of neck surgery;
- Have a history of hyperthyroidism or hypothyroidism.
- Previous history of head and neck radiation therapy;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital
Nanchang, None Selected, 330029
Tianzhu Lu, 8615270186250, lutianzhu2008@163.com
lijingao@hotmail.com
About this study
Official title: The Protection of Thyroid Function in IMRT for Nasopharyngeal Carcinoma: A Retrospective Study
This study aimed to reduce radiation-induced thyroid injury without compromising control of the cervical region by optimizing the delineation of the cervical lymph node drainage area.
Read the detailed description
Since the neck target area of nasopharyngeal carcinoma is close to the thyroid gland, the average dose to the thyroid gland is usually around 54Gy, which is difficult to meet the protection requirements for thyroid protection. In the current guidelines, the inner edge of the common carotid artery is used as the inner boundary of the lymph nodes in levels III and IVa, and the lymphatic drainage area needs to include the inner edge of the common carotid artery. Several studies have found that the centers of positive lymph nodes in cervical regions III and IVa are located outside the inner border of the common carotid artery. In order to better protect the thyroid gland, the investigators have improved the delineation of the neck target area. For patients with negative lymph nodes in regions II and IVa (accounting for about 60% of the total patients), a modified neck target volume delineation method was used to define the inner boundary of regions III and IVa as the outer edge of the common carotid artery. For patients with positive lymph nodes in regions III and IVa (accounting for about 40% of the total patients), the inner boundary of regions III and IVa is defined as the inner edge of the common carotid artery or the outer edge of the thyroid. This study aimed to reduce radiation-induced thyroid injury without compromising control of the cervical region by optimizing the delineation of the cervical lymph node drainage area.
- Being tested
- Modified neck target volume delineation
- Medical subject headings
- Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms, Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified neck target volume delineationRadiation
Modified neck target volume delineation method was used to define the inner boundary of regions III and IVa as the outer edge of the common carotid artery.
| Study group | Role | What they receive |
|---|---|---|
| Modified neck target volume delineation | Experimental | For patients with negative lymph nodes in regions III and IVa, a modified neck target volume delineation method was used to define the inner boundary of regions III and IVa as the outer edge of the common carotid artery. Receives: Radiation: Modified neck target volume delineation |
| Routine neck target volume delineation | No intervention | For patients with negative lymph nodes in regions III and IVa, the inner boundary of regions III and IVa is defined as the inner edge of the common carotid artery or the outer edge of the thyroid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Recurrence-free Survival
From the date of diagnosis to the day of date of diagnosis and the date of regional relapse
Measured: 3 years
Secondary outcomes (3)
Radiation-induced hypothyroidism
From the date of diagnosis to the day of date of diagnosis and the date of regional TSH > upper limit of normal, FT4 normal or less than < lower limit of normal
Measured: 3 years
Overall Survival
From the date of diagnosis to any death, with patients unavailable for follow-up censored at the date of last follow-up
Measured: 3 years
Progression-free Survival
From the date of diagnosis to the data of tumor progression or death (for any cause)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Jan 2019
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268600
- Sponsor's protocol ID
- NPC-Thyroid function
- Status last verified
- Apr 2024
- First submitted
- 13 Feb 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lu T, Gao X, Yu Z, Liu L, Chen X, Xiao Y, Zhong F, Dong Q, Xie H, Tu Z, Xiong X, Chua ML, Li J, Gong X. Reducing radiation-induced hypothyroidism by modified delineation of cervical lymphatic drainage area for nasopharyngeal carcinoma treated by intensity-modulated radiation Therapy: 3 years' experience. Radiother Oncol. 2025 Mar;204:110713. doi: 10.1016/j.radonc.2025.110713. Epub 2025 Jan 10.
PubMed 39800271
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Protection of Thyroid Function in IMRT for Nasopharyngeal Carcinoma: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06268600
- Acronym / sponsor ID
- NPC-Thyroid function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Jiangxi Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 20 Feb 2024 (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.
This study aimed to reduce radiation-induced thyroid injury without compromising control of the cervical region by optimizing the delineation of the cervical lymph node drainage area.
Detailed description
Since the neck target area of nasopharyngeal carcinoma is close to the thyroid gland, the average dose to the thyroid gland is usually around 54Gy, which is difficult to meet the protection requirements for thyroid protection. In the current guidelines, the inner edge of the common carotid artery is used as the inner boundary of the lymph nodes in levels III and IVa, and the lymphatic drainage area needs to include the inner edge of the common carotid artery. Several studies have found that the centers of positive lymph nodes in cervical regions III and IVa are located outside the inner border of the common carotid artery. In order to better protect the thyroid gland, the investigators have improved the delineation of the neck target area. For patients with negative lymph nodes in regions II and IVa (accounting for about 60% of the total patients), a modified neck target volume delineation method was used to define the inner boundary of regions III and IVa as the outer edge of the common carotid artery. For patients with positive lymph nodes in regions III and IVa (accounting for about 40% of the total patients), the inner boundary of regions III and IVa is defined as the inner edge of the common carotid artery or the outer edge of the thyroid. This study aimed to reduce radiation-induced thyroid injury without compromising control of the cervical region by optimizing the delineation of the cervical lymph node drainage area.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified neck target volume delineation | Experimental | Radiation: Modified neck target volume delineationFor patients with negative lymph nodes in regions III and IVa, a modified neck target volume delineation method was used to define the inner boundary of regions III and IVa as the outer edge of the common carotid artery. |
| Routine neck target volume delineation | No intervention | –For patients with negative lymph nodes in regions III and IVa, the inner boundary of regions III and IVa is defined as the inner edge of the common carotid artery or the outer edge of the thyroid. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The pathological diagnosis was newly diagnosed non-keratinizing squamous cell carcinoma nasopharyngeal carcinoma.
- The clinical stage is T1-4N0-3M0 (stage I~IVa, UICC/AJCC 8th edition);
- There is no history of hypothyroidism or hyperthyroidism before treatment;
- Using intensity-modulated radiotherapy technology,
- Complete radical dose radiotherapy;
Key exclusion criteria (7 listed)
- WHO pathological classification is keratinizing squamous cell carcinoma or basaloid carcinoma;
- palliative treatment;
- Have a history of other malignant tumors;
- Pregnant or lactating women (women of childbearing age should consider taking a pregnancy test, and patients are required to use effective contraception during treatment);
- Have a history of neck surgery;
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 |
|---|---|---|
| Modified neck target volume delineationModified neck target volume delineation method was used to define the inner boundary of regions III and IVa as the outer edge of the common carotid artery. | Radiation | Modified neck target volume delineation |
Primary outcome
Regional Recurrence-free Survival
Time frame: 3 years
From the date of diagnosis to the day of date of diagnosis and the date of regional relapse
3 secondary outcomes
Radiation-induced hypothyroidism
Time frame: 3 years
Overall Survival
Time frame: 3 years
Progression-free Survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Derived from this study: PubMed 39800271Lu T, Gao X, Yu Z, Liu L, Chen X, Xiao Y, Zhong F, Dong Q, Xie H, Tu Z, Xiong X, Chua ML, Li J, Gong X. Reducing radiation-induced hypothyroidism by modified delineation of cervical lymphatic drainage area for nasopharyngeal carcinoma treated by intensity-modulated radiation Therapy: 3 years' experience. Radiother Oncol. 2025 Mar;204:110713. doi: 10.1016/j.radonc.2025.110713. Epub 2025 Jan 10.
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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.
Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital
Nanchang, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified neck target volume delineation in people with Nasopharyngeal Carcinoma and Nasopharyngeal Cancer, run by Jiangxi Provincial Cancer Hospital 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 12 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional Recurrence-free Survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06268600, which also lists 1 linked publication.
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 11 Apr 2024.