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NCT Number: NCT06111430

Long-term Neurovascular Complications After Radiation Therapy in Head and Neck Cancer

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.

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Key information

Conditions

Radiation Treatment Neurovascular Complications

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Population: Prospective cohort

Inclusion criteria

  • 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.

Exclusion criteria

  • Age <20 years.
  • Patients not willing to sign the informed consent.

Population: Retrospective validation cohort

Inclusion criteria

  • 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.

Exclusion criteria

1.Age <20 years.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. Significant extracranial vertebral artery stenosis (VAS)

    Time frame: 1 year

    > 50% diameter stenosis on the follow up CT or MR images.

  4. 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.

  5. 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).

  6. 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).

  7. 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).

  8. Tumor recurrence

    Time frame: 1 year

    Relapse

  9. Mortality

    Time frame: 1 year

    Death

Study contacts

Contact information is provided by the study sponsor or research team.

Chi-Hung Liu

CONTACT

[email protected]

(03)3281200 ext. 8340

Hui-Ching Kang

CONTACT

[email protected]

(03)3281200 ext. 5214

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

The Ambidirectional Cohort Study of Neurovascular Complications After Radiation Therapy in Head and Neck Cancer Patients

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Nov 1, 2023
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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