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This is a phase I study to observe the safety and efficacy of irinotecan and bevacizumab combined with re-radiotherapy in the treatment of recurrent glioblastoma. The study will provide a higher level of clinical evidence-based evidence for the clinical treatment of recurrent GBM, and fill the guidelines for the treatment of recurrent GBM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | irinotecan + bevacizumab + Re-radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab,Irinotecan and Re-radiotherapy | Drug | All patients with recurrent glioblastoma will accept irinotecan and bevacizumab combined with re-radiotherapy . |
|
| Measure | Description | Time Frame |
|---|---|---|
| serious adverse events (SAE) | Clinical safety | From baseline to 28 days after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | the time between the date of enrollment of the patient and death from any cause | From the beginning of treatment to death or the last follow-up, approximately 24 months |
| progression free survival |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life score | European Organization for Cancer Research and Treatment Quality of Life Questionnaire (EORTC QLQ-C30) Version 3.0 EORTC QLQ-C30 (Version 3.0) questionnaire for assessing quality of life. | Receive once every two months until you cannot tolerate toxicity or PD, up to about 24 months |
| Cognitive function |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| fei xu, MD | Contact | 18964152276 | xf11976@rjh.com.cn | |
| Yunsheng Gao, MD | Contact | gys11856@rjh.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jiayi Chen, MD | Ruijin Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | 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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The time between the patient's enrollment and any documented tumor progression or death from any cause.
| From the start of treatment to the date of disease progression or death, up to approximately 24 months |
The Mental State Test (MMSE, with a score ranging from 0 to 30) to assess cognitive function. |
| Receive once every two months until you cannot tolerate toxicity or PD, up to about 24 months |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |