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Thirty patients were enrolled in this study, mainly patients with first recurrence of glioblastoma, and the requirement is that they can receive secondary radiotherapy. Regardless of whether the patient has received a second operation or the MGMT promoter is methylated, they can be included in this study. After enrollment, patients were given niraparib 300mg/day (body weight ≥77Kg and baseline platelet count ≥150,000/µL) or 200mg/day (body weight <77Kg or baseline platelet count <150,000/µL), combined with radiotherapy (total dose 55Gy), follow-up Time 1 year. Until the patient has disease progression or intolerance or voluntarily withdraw from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| niraparib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niraparib | Drug | Niraparib 300mg/day (body weight ≥77Kg and baseline platelet count ≥150,000/µL) or 200mg/day (body weight <77Kg or baseline platelet count <150,000/µL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS-6 | 6-month progression-free survival rate | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Uncontrollable nausea and vomiting, inability to swallow study drugs, any gastrointestinal diseases that may interfere with drug absorption and metabolism; active viral infections such as human immunodeficiency virus, hepatitis B, hepatitis C, etc.; uncontrolled ventricular Arrhythmia, myocardial infarction in the last 3 months; uncontrolled grand mal seizures, unstable spinal cord compression, superior vena cava syndrome, or other mental disorders that affect the patient's informed consent; immunodeficiency (except splenectomy) Or other researchers believe that it may expose patients to high-risk toxic diseases; hypertension that cannot be controlled by drugs; and manifestations of intracranial hypertension, intracranial hemorrhage, and intracranial infarction caused by any reason;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Jiang | Contact | +86 22 59065906 | wjianghh@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Jiang | Tianjin Huanhu Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Huanhu Hosptal | Recruiting | Tianjin | Tianjin Municipality | 300350 | China |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| C545685 | niraparib |
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| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |