Radiation TreatmentNCT06111430
Long-term Neurovascular Complications After Radiation Therapy in Head and Neck Cancer
An observational study of Radiation Treatment and Neurovascular Complications, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Head and neck cancer is a group of cancers develop from the soft tissues, salivary gland, mucosa of the upper respiratory or digestive system covering the oral and nasal cavity. Radiotherapy is usually the standard treatment of Head and neck cancers. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Radiation Treatment, Neurovascular Complications
- How many people
- 800 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Apr 2022to 10 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will comprise Head and neck cancer patients recruited in the prospective and retrospective cohorts. The Head and neck cancer patients in this study indicates those coded with ICD 10 (C00-13, C30-32). The coordinating center (Linkou medical center) will establish periodic communications through email and newsletters with participating sites (Keelung branch, Chia-yi branch, and etc.) to ensure data completeness and reduce the odds of loss-to follow-up of patients. We will aim to minimize data queries as much as possible, by prioritizing the completeness of the most relevant data for evaluating the main registry outcomes. We plan to follow up the patients until after 120 months after radiotherapy.
Who may be able to join
- Age ≥20 years.
- Head and neck cancer patient .
- Had ever received radiation therapy (RT) ≦ 72 months before inclusion in the registry.
- Had ≥ 1 brain images and cervical-cranial vascular studies between the end of RT and d date of enrolment.
- Age ≥20 years.
- Head and neck cancer patient.
- Had ever received radiation therapy (RT) > 120 months before the adoption date of IRB at the participant site.
- Had ≥ 2 brain images and cervical-cranial vascular studies between the end of RT and 6~10 years after RT, one within 5 years after RT, the other after 5 years after RT.
Who cannot join
- Age <20 years.
- Patients not willing to sign the informed consent.
- Population: Retrospective validation cohort
- 1.Age <20 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taipei
Chi-Hung Liu, 033281200 ext. 8340, ivanliu001@cgmh.org.tw
Hui-Ching Kang, 033281200 ext. 5214, karen0201kang@gmail.com
About this study
Official title: The Ambidirectional Cohort Study of Neurovascular Complications After Radiation Therapy in Head and Neck Cancer Patients
Head and neck cancer is a group of cancers develop from the soft tissues, salivary gland, mucosa of the upper respiratory or digestive system covering the oral and nasal cavity. Radiotherapy is usually the standard treatment of Head and neck cancers. In the present study, investigators aim to study the prevalence of cervical-cranial vascular complications during the early stages in these Head and neck cancer patients receiving Radiotherapy. Investigators will also compare the results between Nasopharyngeal cancer and other Head and neck cancerpatients receiving Radiotherapy.
- Conditions
- Radiation Treatment, Neurovascular Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant CAS at internal carotid artery or common carotid artery
We define significant CAS as (a) >50% stenosis on the B-mode with peak systolic velocities ≥120 cm/s based on the hemodynamic criteria at any internal carotid artery or common carotid artery in the CDU study according to the standard ultrasound criteria35; or (b) > 50% diameter stenosis on the follow up CT or MR images.
Measured: 1 year
Cerebral infarctions (CI)
The CI is defined whenever there were symptomatic IS occurrence of presence of asymptomatic IS on the reviewed brain MRIs.
Measured: 1 year
Significant extracranial vertebral artery stenosis (VAS)
> 50% diameter stenosis on the follow up CT or MR images.
Measured: 1 year
Significant intracranial artery stenosis
Presence of > 50% stenosis at intracranial ICA/VA, basilar artery, middle cerebral artery, anterior cerebral artery, or anterior cerebral artery.
Measured: 1 year
Presence of carotid blow-out syndrome
Carotid blow out syndrome was categorized as type 1 (threaten type), type 2 (impending blowouts), and type 3 (acute CBS hemorrhage).
Measured: 1 year
Presence of TLN
We will identify white matter lesions, contrast-enhanced lesions, Cysts, and local mass effect. The white matter lesions in the temporal lobe will be divided into three groups: mild (small focal areas), moderate (larger confluent areas) and severe (large confluent areas extending outside the radiation field with or without local mass effect). The cysts will be evaluated for size and number. The local mass effect will be classified as mild (affecting only the temporal lobe sulci), moderate (affecting the sulci and ventricles) and severe (affecting the midline of the brain).
Measured: 1 year
Presence of hypothyroidism
Clinical hypothyroidism was diagnosed when a patient had free T4 ≤ 0.80 ng/dL with elevated TSH (>5.0 mU/L).
Measured: 1 year
Tumor recurrence
Relapse
Measured: 1 year
Mortality
Death
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start11 Apr 2022
- Primary completion10 Apr 2023
- Study completion10 Apr 2027 (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 Radiation TreatmentStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111430
- Sponsor's protocol ID
- 202200464B0
- Status last verified
- Apr 2026
- First submitted
- 17 Oct 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang JL, Chang JT, Huang BS, Chang TY, Sung PS, Wei YC, Lin CY, Yeh CH, Fan KH, Liu CH. Post-irradiation vertebral and carotid stenosis heightens stroke risk in head and neck cancer. BMC Cancer. 2025 Feb 11;25(1):235. doi: 10.1186/s12885-025-13647-6.
PubMed 39934712
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ambidirectional Cohort Study of Neurovascular Complications After Radiation Therapy in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT06111430
- Acronym / sponsor ID
- 202200464B0
- Conditions
- Radiation Treatment, Neurovascular Complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2027 (estimated)
- First posted
- 1 Nov 2023 (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.
Head and neck cancer is a group of cancers develop from the soft tissues, salivary gland, mucosa of the upper respiratory or digestive system covering the oral and nasal cavity. Radiotherapy is usually the standard treatment of Head and neck cancers. In the present study, investigators aim to study the prevalence of cervical-cranial vascular complications during the early stages in these Head and neck cancer patients receiving Radiotherapy. Investigators will also compare the results between Nasopharyngeal cancer and other Head and neck cancerpatients receiving Radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will comprise Head and neck cancer patients recruited in the prospective and retrospective cohorts. The Head and neck cancer patients in this study indicates those coded with ICD 10 (C00-13, C30-32). The coordinating center (Linkou medical center) will establish periodic communications through email and newsletters with participating sites (Keelung branch, Chia-yi branch, and etc.) to ensure data completeness and reduce the odds of loss-to follow-up of patients. We will aim to minimize data queries as much as possible, by prioritizing the completeness of the most relevant data for evaluating the main registry outcomes. We plan to follow up the patients until after 120 months after radiotherapy.
Key inclusion criteria (8 listed)
- Age ≥20 years.
- Head and neck cancer patient .
- Had ever received radiation therapy (RT) ≦ 72 months before inclusion in the registry.
- Had ≥ 1 brain images and cervical-cranial vascular studies between the end of RT and d date of enrolment.
- Age ≥20 years.
Key exclusion criteria (4 listed)
- Age <20 years.
- Patients not willing to sign the informed consent.
- Population: Retrospective validation cohort
- 1.Age <20 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Significant CAS at internal carotid artery or common carotid artery
Time frame: 1 year
We define significant CAS as (a) >50% stenosis on the B-mode with peak systolic velocities ≥120 cm/s based on the hemodynamic criteria at any internal carotid artery or common carotid artery in the CDU study according to the standard ultrasound criteria35; or (b) > 50% diameter stenosis on the follow up CT or MR images.
Cerebral infarctions (CI)
Time frame: 1 year
The CI is defined whenever there were symptomatic IS occurrence of presence of asymptomatic IS on the reviewed brain MRIs.
Significant extracranial vertebral artery stenosis (VAS)
Time frame: 1 year
> 50% diameter stenosis on the follow up CT or MR images.
Significant intracranial artery stenosis
Time frame: 1 year
Presence of > 50% stenosis at intracranial ICA/VA, basilar artery, middle cerebral artery, anterior cerebral artery, or anterior cerebral artery.
Presence of carotid blow-out syndrome
Time frame: 1 year
Carotid blow out syndrome was categorized as type 1 (threaten type), type 2 (impending blowouts), and type 3 (acute CBS hemorrhage).
Presence of TLN
Time frame: 1 year
We will identify white matter lesions, contrast-enhanced lesions, Cysts, and local mass effect. The white matter lesions in the temporal lobe will be divided into three groups: mild (small focal areas), moderate (larger confluent areas) and severe (large confluent areas extending outside the radiation field with or without local mass effect). The cysts will be evaluated for size and number. The local mass effect will be classified as mild (affecting only the temporal lobe sulci), moderate (affecting the sulci and ventricles) and severe (affecting the midline of the brain).
Presence of hypothyroidism
Time frame: 1 year
Clinical hypothyroidism was diagnosed when a patient had free T4 ≤ 0.80 ng/dL with elevated TSH (>5.0 mU/L).
Tumor recurrence
Time frame: 1 year
Relapse
Mortality
Time frame: 1 year
Death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Derived from this study: PubMed 39934712Jiang JL, Chang JT, Huang BS, Chang TY, Sung PS, Wei YC, Lin CY, Yeh CH, Fan KH, Liu CH. Post-irradiation vertebral and carotid stenosis heightens stroke risk in head and neck cancer. BMC Cancer. 2025 Feb 11;25(1):235. doi: 10.1186/s12885-025-13647-6.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Treatment and Neurovascular Complications, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi-Hung Liu ((03)3281200 ext. 8340, ivanliu001@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant CAS at internal carotid artery or common carotid artery (time frame: 1 year). The study lists 9 primary outcomes in all. 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 NCT06111430, 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 22 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.