Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury

Study Overview
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Brief Summary
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To investigate the effect of Bevacizumab on asymptomatic radiotherapy-induced brain injury patients with head and neck cancer.

Detailed Description
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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.

Official Title
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Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury in Patients With Head and Neck Cancer

Conditions
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Brain Injuries

Intervention / Treatment
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* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HNC patients with radiation-induced brain injury.<br>Bevacizumab 2.5mg/kg， q2w，4 cycles. | Drug: Bevacizumab<br>* Bevacizumab 2.5mg/kg, q2w, 4 cycles.<br>|
| No Intervention: HNC patients without brain injury after radiotherapy.<br>No treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence and duration of onset of clinical symptoms. | The incidence and duration of onset of clinical symptoms within 1 year after treatment between the treatment group and the control group. | Change form baseline to evaluation at 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of RI volume. | The change of RI volume between the treatment group and the control group. | Change form baseline to evaluation at 1 year. | 
| change of cognitive function. | 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 form baseline to evaluation at 1 year. | 
| overall survival | the overall survival between the treatment group and the control group. | Change form baseline to evaluation at 1 year. | 
| change of quality of life. | 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. | Change form baseline to evaluation at 1 year. |