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| Name | Class |
|---|---|
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| Cancer Hospital of Guangxi Medical University | OTHER |
| Liuzhou Workers' Hospital | OTHER_GOV |
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For patients with glioblastoma,postoperative radiotherapy combined with concurrent and adjuvant temozolomide (Stupp regimen) has long been considered a standard treatment approach.The treatment outcomes, however, are still dismal, with a median overall survival time of 8-12 months. As a novel small molecule multi-target tyrosine kinase inhibitor, anlotinib hydrochloride has been found to be able to inhibit both tumor angiogenesis and cell growth.Previous studies on recurrent glioblastoma have demonstrated its effectiveness in tumor control with manageable toxicities. The current study is designed to evaluate the efficacy and feasibility of the additional anlotinib hydrochloride to the Stupp regimen for newly diagnosed glioblastoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation therapy, Temozolomide and anlotinib | Experimental | Patients will receive standard radiation therapy plus temozolomide (Stupp regimen). Anlotinib hydrochloride will be given with a daily dose of 12 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities. |
|
| Radiation therapy and temozolomide | Active Comparator | Patients will receive standard radiation therapy plus temozolomide (Stupp regimen). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib Hydrochloride | Drug | Anlotinib hydrochloride will be given with a daily dose of 12 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 3 years | |
| Objective response rate | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heming Lu, MD | Contact | 86-771-2186-504 | gxheminglu@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanxishan Hospital of Guangxi Zhuang Autonomous Region | Guilin | Guangxi | 541002 | China | ||
| Liuzhou Worker's Hospital |
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| Nanxishan Hospital |
| UNKNOWN |
| LiuZhou People's Hospital | OTHER |
| Affiliated Hospital of Guilin University | UNKNOWN |
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|
| Radiation therapy | Radiation | Radiation therapy will be delivered in daily fractions of 2 Gy given 5 days a week for a total of 60 Gy. |
|
| Temozolomide | Drug | Temozolomide will be administered at a daily dose of 75 mg/m2 until the completion of radiation therapy. Four weeks after the completion of radiation therapy, patients will be given with adjuvant chemotherapy with temozolomide at a dose of 150-200 mg/m2 for 5 days of a 28-day cycle for a total of 6 cycles. |
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| Liuzhou |
| Guangxi |
| 545005 |
| China |
| Liuzhou People's Hospital | Liuzhou | Guangxi | 545006 | China |
| Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530021 | China |
| Affiliated Tumor Hospital of Guangxi Medical University | Nanning | Guangxi | 530021 | China |
| People's Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi | 530021 | China |
|
| Yulin First Hospital | Yulin | Guangxi | 537000 | China |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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