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| ID | Type | Description | Link |
|---|---|---|---|
| SYS-2016004 | Registry Identifier | Sun Yat-sen Memorial Hospital, Neurology department |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab and steroid | Experimental | 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 and placebo | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab and steroid | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in magnetic resonance imaging (MRI) of radiation-induced brain necrosis in patients | Change in MRI of radiation-induced brain necrosis in patients | Change form baseline to evaluation at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of neurologic function of patients after treatment | Change of neurologic function assessed using LENT/SOMA sacle of patients after treatment | Change from baseline to evaluation at 12 weks. |
| Change of quality of life of patients after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tang Yamei, Ph.D | Contact | 86-13556001992 | yameitang@hotmail.com | |
| Yi Li, Ph.D | Contact | 86-15018761512 | 1024254327@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Tang Yamei, Ph.D | sun yat-sen memorial hospital,sun yat-sen universicy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| D011832 | Radiation Injuries |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Bevacizumab and placebo | Drug | 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. |
|
Change of quality of life using QOL scale of patients after treatment
| Change from baseline to evaluation at 12 weeks. |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D014947 | Wounds and Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |