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

Radiation Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111430
• Other study ID #: 202200464B0
• Status: Recruiting
• Start date: April 11, 2022
• Est. completion date: April 10, 2026

Study information

• Verified date: April 2023
• Source: Chang Gung Memorial Hospital
• Contact: Chi-Hung Liu
• Phone: (03)3281200
• Email: ivanliu001[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: April 10, 2026
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Radiation Treatment

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Significant extracranial vertebral artery stenosis (VAS)	> 50% diameter stenosis on the follow up CT or MR images.	1 year
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Tumor recurrence	Relapse	1 year
Primary	Mortality	Death	1 year