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The purpose of this study is to evaluate the clinical benefit and safety of two different Dose-Intense temozolomide regimens(one-week on/one-week off regimen versus continuous dose-intense regimen)in patients with glioblastoma at first relapse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1 ,one-week on/one-week off regimen | Experimental | One-week on/one-week off regimen is administered for 12 cycles of 28 days. Arm 1 receives temozolomide 150 mg/m2 daily during days 1 to 7 and 15 to 21 of each cycle.Treatment will continue until tumor progression, development of excessive toxicity, withdrawal of consent, or completion of 12 cycles. |
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| Arm 2,continuous dose-intense regimen | Experimental | Continuous dose-intense regimen is administered for 12 cycles of 28 days .Arm 2 receives temozolomide 50mg/m2 daily during days 1 to 28 of each cycle. Treatment will continue until tumor progression, development of excessive toxicity, withdrawal of consent, or completion of 12 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temozolomide | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Progress-Free Survival at 6 months (PFS6) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | 2 years | |
| Progression free survival | 2 years | |
| Objective Response Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Junping Zhang, MD | Beijing Sanbo Brain Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| up to 52 weeks |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | up to 52 weeks |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |