Back to resultsEtoposide Plus Cisplatin Compared With Temozolomide in Patients With Glioblastoma
Primary Purpose
MGMT-Unmethylated Glioblastoma
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Etoposide Plus Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for MGMT-Unmethylated Glioblastoma focused on measuring Etoposide Plus Cisplatin, Temozolomide, MGMT-Unmethylated Glioblastoma
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Etoposide Plus Cisplatin group
Temozolomide group
Arm Description
Etoposide 100mg/m2 d1-5 Cisplatin 20mg/mCisplatin d1-5
Temozolomide 150-200mg/m2 d1-5
Outcomes
Primary Outcome Measures
OVER SURVIVAL
The length of time from the date of diagnosis to death from cancer
Secondary Outcome Measures
PFS
the length of time after primary treatment for glioblastoma ends that the patient survives without any progression of glioblastoma.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05694416
Brief Title
Etoposide Plus Cisplatin Compared With Temozolomide in Patients With Glioblastoma
Official Title
Etoposide Plus Cisplatin Compared With Temozolomide in Patients With Newly Diagnosed MGMT Promotor Unmethylated Glioblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongnan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 (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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MGMT-Unmethylated Glioblastoma
Keywords
Etoposide Plus Cisplatin, Temozolomide, MGMT-Unmethylated Glioblastoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Etoposide Plus Cisplatin group
Arm Type
Experimental
Arm Description
Etoposide 100mg/m2 d1-5 Cisplatin 20mg/mCisplatin d1-5
Arm Title
Temozolomide group
Arm Type
No Intervention
Arm Description
Temozolomide 150-200mg/m2 d1-5
Intervention Type
Drug
Intervention Name(s)
Etoposide Plus Cisplatin
Other Intervention Name(s)
EP
Intervention Description
Etoposide Plus Cisplatin ivdrip d1-5
Primary Outcome Measure Information:
Title
OVER SURVIVAL
Description
The length of time from the date of diagnosis to death from cancer
Time Frame
2 YEARS
Secondary Outcome Measure Information:
Title
PFS
Description
the length of time after primary treatment for glioblastoma ends that the patient survives without any progression of glioblastoma.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yahua Zhong, Phd
Phone
08602767813154
Email
doctorzyh73@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianyin Huang, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianyin Huang, MD
Organizational Affiliation
Wuhan University
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Etoposide Plus Cisplatin Compared With Temozolomide in Patients With Glioblastoma
We'll reach out to this number within 24 hrs