Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury
- Registration Number
- NCT05303259
- Brief Summary
To investigate the effect of Bevacizumab on asymptomatic radiotherapy-induced brain injury patients with head and neck cancer.
- Detailed Description
Radiotherapy-induced brain injury (RI) is a serious complication of radiotherapy in head and neck cancer (HNC) patients. Previous studies have confirmed that Bevacizumab has a good effect on patients with symptomatic RI .However, patients with RI maybe do not show clinical symptoms in the early stage. The clinical symptoms will appear with the progression of the RI lesion. There has been no relevant research on whether early intervention is necessary for asymptomatic RI. The investigators conduct this multicenter, randomized clinical research to explore the efficacy and safety of Bevacizumab in asymptomatic RI.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 204
Head MRI confirmed RI lesions. Sign the informed consent.
With clinical symptoms of RI lesions. Head MRI showed bleeding lesions Contraindications of Bevacizumab. Pregnant women and parturient women.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HNC patients with radiation-induced brain injury. Bevacizumab Bevacizumab 2.5mg/kg， q2w，4 cycles.
- Primary Outcome Measures
Name Time Method The incidence and duration of onset of clinical symptoms. Change form baseline to evaluation at 1 year. The incidence and duration of onset of clinical symptoms within 1 year after treatment between the treatment group and the control group.
- Secondary Outcome Measures
Name Time Method change of RI volume. Change form baseline to evaluation at 1 year. The change of RI volume between the treatment group and the control group.
overall survival Change form baseline to evaluation at 1 year. the overall survival between the treatment group and the control group.
change of cognitive function. Change form baseline to evaluation at 1 year. The change of cognitive function (MoCa scores) between the treatment group and the control group. The MoCA score ranges from 0 to 30, and higher scores mean a better outcome.
change of quality of life. Change form baseline to evaluation at 1 year. The change of quality of life ( WHOQOL scale) between the treatment group and the control group. The higher the QOL scores mean a better outcome.
Trial Locations
- Locations (1)
Sun Yat-Sen Memorial Hospital
🇨🇳Guangzhou, Guangdong, China