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Temozolomide (TMZ) is an oral chemotherapy drug. It is an alkylating agent used as a first-line treatment for glioblastoma. This methylation damages the DNA and triggers the death of tumor cells. According to the results of several clinical studies, TMZ synchronous plus radiotherapy and subsequent as adjuvant therapy can significantly improve the survival rate of newly diagnosed glioblastoma patients.
Glioma is the highest incidence of the central nervous system tumor. Surgical treatment is one of the most important therapeutic methods in patients with glioblastoma. But since malignant glioma is a highly invasive tumor, the rate of surgery failure is . So the postoperative therapy shall be accompanied by radiotherapy. Since 1998, the clinical application of Temozolomide(TMZ) has brought hope for malignant glioma patients with its definite curative effect. According to the results of several clinical studies, TMZ synchronous plus radiotherapy and subsequent as adjuvant therapy can significantly improve the survival rate of newly diagnosed GBM patients and break the survival limit of malignant glioma patients. Besides, antiangiogenic therapy is also a choice for the treatment of glioblastoma patients. Vascular endothelial growth factor receptors (VEGFRs) inhibitors block the new formation around the tumor and cut down the supply of oxygen, nutrients and metabolic waste, so that the tumor is hard to proliferate and metastases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1 | concurrent chemoradiotherapy(Temozolomide+apatinib) maintenance therapy(Temozolomide) |
| |
| control | concurrent chemoradiotherapy(Temozolomide) maintenance therapy(Temozolomide) |
| |
| Experimental 2 | concurrent chemoradiotherapy(Temozolomide+apatinib) maintenance therapy(Temozolomide+apatinib) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | These drugs are planned to inhibit the proliferation and metastasis of tumors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free-Survival(PFS) | in this Survival Duration neither Progression nor death occurs in the subjects. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months. |
| Assessment of brain edema | The average score of edema grading in patients before and after treatment was calculated separately. | From date of randomization until the date of end of the trial, assessed up to 36 months |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | To observe any adverse events that occurred during the clinical study. | From date of randomization until the date of end of the trial, assessed up to 36 months |
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Search Criteria:
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Subjects are all previously received anti-angiogenesis drugs simultaneous accompanied with radio-and chemotherapy in Fuzhou Zongyuan since October, 2017.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenmin Ying, Bachelor | Contact | 15080015210 | 18352770@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuzhou General Hospital | Recruiting | Fuzhou | Fujian | 350025 | 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 |
|---|---|
| C553458 | apatinib |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Temozolomide(TMZ) | Drug | Radiotherapy is a common treatment for glioblastoma.Accompanied with TMZ, the damages caused by tumors to the normal tissues will be reduced. |
|
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |