Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma

Fudan University

Status: Unknown

Conditions: Nasopharyngeal Carcinoma; Carotid Artery Diseases

Treatments: Other: Medical history of cardiovascular risk factors and cardiovascular diseases; Diagnostic Test: Montreal Cognitive Assessment; Diagnostic Test: Carotid Color Flow Duplex Testing; Diagnostic Test: Detection and measurement of carotid plaques; Diagnostic Test: Measurement of intima media thickness of carotid artery

Study type: Observational

Funder types: Other

Identifiers

NCT03568032

NPC-CAROTID-01

Details and patient eligibility

About

Radiation-associated carotid vasculopathy is a common late sequelae in patients with head and neck cancer, which correlates with the incidence of stroke. Currently, little is known about the incidence of radiation-associated carotid vasculopahty in the context of intensity-modulated radiation therapy (IMRT).

The aim of this study is to determine whether IMRT will increase the incidence of carotid vasculopathy in patients with nasopharyngeal carcinoma (NPC).

Enrollment: 248 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• signed inform consent
• age more than 18 years old
• ECOG 0-2
• pathologic diagnosed, non-metastatic NPC
• either untreated or treated by definitive IMRT 3 years ago
• did not receive radiation to the head and neck region prior to the diagnosis of NPC
• if the patient received definitive IMRT 3 years ago because of NPC, he or she did not receive a second course of radiation due to local relapse
• no prior surgery of head and neck

Exclusion criteria

• prior history of cardiovascular disease before the diagnosis of NPC
• prior radiation to head and neck before the diagnosis of NPC
• prior surgery of head and neck
• pregnant or lactating women

Trial design

248 participants in 2 patient groups

the post-radiation group

Description:

patients diagnosed as non-metastatic nasopharyngeal carcinoma who received definitive IMRT more than 3 years ago

Treatment:

Diagnostic Test: Montreal Cognitive Assessment

Diagnostic Test: Carotid Color Flow Duplex Testing

Other: Medical history of cardiovascular risk factors and cardiovascular diseases

Diagnostic Test: Detection and measurement of carotid plaques

Diagnostic Test: Measurement of intima media thickness of carotid artery

the pre-radiation group

Description:

untreated patients diagnosed as non-metastatic nasopharyngeal carcinoma

Treatment:

Diagnostic Test: Montreal Cognitive Assessment

Diagnostic Test: Carotid Color Flow Duplex Testing

Other: Medical history of cardiovascular risk factors and cardiovascular diseases

Diagnostic Test: Detection and measurement of carotid plaques

Diagnostic Test: Measurement of intima media thickness of carotid artery