Treatment of bevacizumab followed by steroid may have a better effect on patients with radiation-induced brain injury.This randomized trial aims to investigate whether treatment of bevacizumab followed by steroid may alleviate radiation-induced brain injury in patients with nasopharyngeal carcinoma. The effect will be compared with outcomes in patients receiving steroid therapy
Radiation-induced brain injury is a severe complication of radiotherapy in patients with Nasopharyngeal carcinoma. Current neuroprotective therapies show limited benefit in ameliorating this complication of radiotherapy. This study is a randomized, single blind clinical study. The primary aim of this study is to determine whether treatment of bevacizumab followed by steroid can alleviate radiation-induced brain injury in patients with nasopharyngeal carcinoma, and to compare the treating effect between combination of bevacizumab and steroid and bevacizumab alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
86
Bevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential prednisone 10mg / d orally, the total course of 12 weeks.
Bevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential placebo 2 pills per day orally, the total course of 12 weeks.
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGChange in magnetic resonance imaging (MRI) of radiation-induced brain necrosis in patients
Change in MRI of radiation-induced brain necrosis in patients
Time frame: Change form baseline to evaluation at 12 weeks
Change of neurologic function of patients after treatment
Change of neurologic function assessed using LENT/SOMA sacle of patients after treatment
Time frame: Change from baseline to evaluation at 12 weks.
Change of quality of life of patients after treatment
Change of quality of life using QOL scale of patients after treatment
Time frame: Change from baseline to evaluation at 12 weeks.
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