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

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.

Study Overview

• Status: Recruiting
• Conditions: Radiation Treatment; Neurovascular Complications

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Chi-Hung Liu; Phone Number: 8340 (03)3281200; Email: ivanliu001@cgmh.org.tw
• Study Contact Backup: Name: Hui-Ching Kang; Phone Number: 5214 (03)3281200; Email: karen0201kang@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Chi-Hung Liu; Phone Number: 8340 033281200; Email: ivanliu001@cgmh.org.tw
    • Contact: Hui-Ching Kang; Phone Number: 5214 033281200; Email: karen0201kang@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Population: Prospective cohort

Inclusion Criteria:

1. Age ≥20 years.
2. Head and neck cancer patient .
3. Had ever received radiation therapy (RT) ≦ 72 months before inclusion in the registry.
4. Had ≥ 1 brain images and cervical-cranial vascular studies between the end of RT and d date of enrolment.

Exclusion Criteria:

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

Population: Retrospective validation cohort

Inclusion Criteria:

1. Age ≥20 years.
2. Head and neck cancer patient.
3. Had ever received radiation therapy (RT) > 120 months before the adoption date of IRB at the participant site.
4. 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Death	1 year
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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2022
• Primary Completion (Actual): April 10, 2023
• Study Completion (Estimated): April 10, 2026

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 202200464B0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No