Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury in Patients With Head and Neck Cancer
Overview
- Phase
- Phase 2
- Intervention
- Bevacizumab
- Conditions
- Brain Injuries
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Enrollment
- 204
- Locations
- 1
- Primary Endpoint
- The incidence and duration of onset of clinical symptoms.
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Head MRI confirmed RI lesions. Sign the informed consent.
Exclusion Criteria
- •With clinical symptoms of RI lesions. Head MRI showed bleeding lesions Contraindications of Bevacizumab. Pregnant women and parturient women.
Arms & Interventions
HNC patients with radiation-induced brain injury.
Bevacizumab 2.5mg/kg， q2w，4 cycles.
Intervention: Bevacizumab
Outcomes
Primary Outcomes
The incidence and duration of onset of clinical symptoms.
Time Frame: 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 Outcomes
- change of RI volume.(Change form baseline to evaluation at 1 year.)
- change of cognitive function.(Change form baseline to evaluation at 1 year.)
- overall survival(Change form baseline to evaluation at 1 year.)
- change of quality of life.(Change form baseline to evaluation at 1 year.)