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

Recruiting

• Conditions: Neurovascular Complications; Radiation Treatment

• Registration Number: NCT06111430
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-11
• Primary Completion: 2023-04-10
• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-26
• Study First Posted: 2023-11-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Study Completion: 2026-04-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Significant intracranial artery stenosis	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	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 hypothyroidism	1 year	Clinical hypothyroidism was diagnosed when a patient had free T4 ≤ 0.80 ng/dL with elevated TSH (\>5.0 mU/L).
Significant CAS at internal carotid artery or common carotid artery	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)	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)	1 year	\> 50% diameter stenosis on the follow up CT or MR images.
Presence of TLN	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).
Tumor recurrence	1 year	Relapse
Mortality	1 year	Death

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taipei, Taiwan