Etoposide Plus Cisplatin Compared With Temozolomide in Patients With Glioblastoma

Study Overview
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Brief Summary
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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 Etoposide plus Cisplatin and Temozolomide in patients with MGMT gene promoter unmethylation glioblastoma.

Detailed Description
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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

Official Title
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Etoposide Plus Cisplatin Compared With Temozolomide in Patients With Newly Diagnosed MGMT Promotor Unmethylated Glioblastoma

Conditions
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MGMT-Unmethylated Glioblastoma

Intervention / Treatment
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* Drug: Etoposide Plus Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion 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. adequate hematologic, hepatic, and renal function Exclusion Criteria: younger than 18 years; with a prior (i.e. within 5 years) or synchronous malignancy, other than non-melanoma skin cancer; and those with significant comorbidities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etoposide Plus Cisplatin group<br>Etoposide 100mg/m2 d1-5 Cisplatin 20mg/mCisplatin d1-5 | Drug: Etoposide Plus Cisplatin<br>* Etoposide Plus Cisplatin ivdrip d1-5<br>* Other names: EP;|
| No Intervention: Temozolomide group<br>Temozolomide 150-200mg/m2 d1-5 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OVER SURVIVAL | The length of time from the date of diagnosis to death from cancer | 2 YEARS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | the length of time after primary treatment for glioblastoma ends that the patient survives without any progression of glioblastoma. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Etoposide Plus Cisplatin, Temozolomide, MGMT-Unmethylated Glioblastoma