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To investigate the effect of Bevacizumab on asymptomatic radiotherapy-induced brain injury patients with head and neck cancer.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HNC patients with radiation-induced brain injury. | Experimental | Bevacizumab 2.5mg/kg， q2w，4 cycles. |
|
| HNC patients without brain injury after radiotherapy. | No Intervention | No treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab 2.5mg/kg, q2w, 4 cycles. |
|
| 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. |
| 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. |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yamei Tang, PHD | Contact | +86 13556001992 | tangym@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yamei Tang, Ph.D | sun yat-sen memorial hospital,sun yat-sen universicy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 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. |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |