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Recruiting NCT06111430

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

Observational Radiation Treatment Neurovascular Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Radiation Treatment, Neurovascular Complications. Basic parameters: 20 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Significant CAS at internal carotid artery or common carotid artery [Time frame: 1 year]
  • Cerebral infarctions (CI) [Time frame: 1 year]
  • Significant extracranial vertebral artery stenosis (VAS) [Time frame: 1 year]
  • Significant intracranial artery stenosis [Time frame: 1 year]
  • Presence of carotid blow-out syndrome [Time frame: 1 year]
  • Presence of TLN [Time frame: 1 year]
  • Presence of hypothyroidism [Time frame: 1 year]
  • Tumor recurrence [Time frame: 1 year]
  • Mortality [Time frame: 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Taiwan · 1 center
  • Chang Gung Memorial Hospital — Taipei

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. PMID 39934712

Identifiers

NCT: NCT06111430 · 202200464B0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗