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Trial Title:
Etoposide Plus Cisplatin Compared With Temozolomide in Patients With Glioblastoma
NCT ID:
NCT05694416
Condition:
MGMT-Unmethylated Glioblastoma
Conditions: Official terms:
Glioblastoma
Etoposide
Conditions: Keywords:
Etoposide Plus Cisplatin
Temozolomide
MGMT-Unmethylated Glioblastoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
Etoposide Plus Cisplatin
Description:
Etoposide Plus Cisplatin ivdrip d1-5
Arm group label:
Etoposide Plus Cisplatin group
Other name:
EP
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
February 1, 2023
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Zhongnan Hospital
Agency class:
Other
Source:
Zhongnan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05694416
