Long-term Neurovascular Complications After Radiation Therapy in Head and Neck Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-100
SponsorChang Gung Memorial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Age <20 years.
Patients not willing to sign the informed consent.
Age ≥20 years.
Head and neck cancer patient.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
1 year2
Cerebral infarctions (CI)
The CI is defined whenever there were symptomatic IS occurrence of presence of asymptomatic IS on the reviewed brain MRIs.
Time frame
1 year3
Significant extracranial vertebral artery stenosis (VAS)
\> 50% diameter stenosis on the follow up CT or MR images.
Time frame
1 year4
Significant intracranial artery stenosis
Presence of \> 50% stenosis at intracranial ICA/VA, basilar artery, middle cerebral artery, anterior cerebral artery, or anterior cerebral artery.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov