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Temozolomide provided significant and clinically meaningful benefit in MGMT gene promoter methylation glioblastoma. However, in unmethylated patients, the effect of Temozolomide is limited. The aim of this study is to compare the effect of Cisplatin plus Temozolomide and Temozolomide in patients with MGMT gene promoter unmethylation glioblastoma
60 Patients with glioblastoma were recruited for this study based on the following eligibility criteria: Age between 18 and 70, performance status of 0-1 (Eastern Cooperative Oncology Group performance status), histologically confirmed MGMT gene promoter unmethylation glioblastoma, no cerebrospinal fluid and distant metastatic disease. All patients had adequate hematologic, hepatic, and renal function. Patients younger than 18 years; patients with a prior (i.e. within 5 years) or synchronous malignancy, other than non-melanoma skin cancer; and those with significant comorbidities were excluded.
60 patients were randomly divided into two groups and compared the difference of efficacy between the two groups
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Cisplatin 20mg/m2 Cisplatin days 1-5 plus Temozolomide 150-200mg/m2 days 1-5 |
|
| Temozolomide | Active Comparator | Temozolomide 150-200mg/m2 days 1-5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin Plus Temozolomide | Drug | Cisplatin Plus Temozolomide . Cisplatin 20mg/mCisplatin days 1-5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The length of time from the date of diagnosis to death from cancer | 1 YEAR |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | the length of time after primary treatment for glioblastoma ends that the patient survives without any progression of glioblastoma | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Temozolomide | Drug | Temozolomide |
|
| D003606 |
| Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |