Brief Title
Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma
Official Title
The Clinical Study of Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma Treated by IMRT
Brief Summary
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).
Study Type
Observational
Primary Outcome
intima media thickness of carotid artery
Secondary Outcome
the incidence of carotid stenosis
Condition
Nasopharyngeal Carcinoma
Intervention
Measurement of intima media thickness of carotid artery
Study Arms / Comparison Groups
the post-radiation group
Description: patients diagnosed as non-metastatic nasopharyngeal carcinoma who received definitive IMRT more than 3 years ago
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
248
Start Date
July 1, 2018
Completion Date
June 30, 2019
Primary Completion Date
May 1, 2019
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Xiayun He, MD, +86 13816287320, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03568032
Organization ID
NPC-CAROTID-01
Responsible Party
Principal Investigator
Study Sponsor
Fudan University
Study Sponsor
Xiayun He, MD, Principal Investigator, Fudan University
Verification Date
June 2018