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

NCT06111430 | Recruiting

• 1 other identifier: 202200464B0
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  1 year

• Significant extracranial vertebral artery stenosis (VAS)

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

  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.

  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).

  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).

  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).

  1 year

• Tumor recurrence

  Relapse

  1 year

• Mortality

  Death

  1 year

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Age ≥20 years.
• Head and neck cancer patient .
• Had ≥ 1 brain images and cervical-cranial vascular studies between the end of RT and d date of enrolment.

You may not qualify if:

• Age \<20 years.
• Patients not willing to sign the informed consent.
• Population: Retrospective validation cohort
• 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.
• Age \<20 years.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, Taiwan

RECRUITING

Related Publications (1)

• 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 DERIVED

Central Study Contacts

Chi-Hung Liu

CONTACT

(03)3281200; ivanliu001@cgmh.org.tw

Hui-Ching Kang

CONTACT

(03)3281200; karen0201kang@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: November 1, 2023
• Study Start: April 11, 2022
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2026
• Last Updated: March 20, 2026

Record last verified: 2025-04

Locations

TW (1)