Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05694416
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-01-23
First Post:
2023-01-12
Brief Title:
Etoposide Plus Cisplatin Compared With Temozolomide in Patients With Glioblastoma
Sponsor:
Zhongnan Hospital
Organization:
Zhongnan Hospital
Study Overview
Official Title:
Etoposide Plus Cisplatin Compared With Temozolomide in Patients With Newly Diagnosed MGMT Promotor Unmethylated Glioblastoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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 ie 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
60 patients were randomly divided into two groups and compared the difference of efficacy between the two groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None