Etoposide Plus Cisplatin Compared With Temozolomide in Patients With Glioblastoma

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05694416

Enrollment

Registered

2023-01-23

Start date

2023-02-01

Completion date

2025-03-01

Last updated

2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MGMT-Unmethylated Glioblastoma

Keywords

Etoposide Plus Cisplatin, Temozolomide, MGMT-Unmethylated Glioblastoma

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

Interventions

DRUGEtoposide Plus Cisplatin

Etoposide Plus Cisplatin ivdrip d1-5

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
OVER SURVIVAL	2 YEARS	The length of time from the date of diagnosis to death from cancer

Secondary

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

Contacts

Primary ContactYahua Zhong, Phd

doctorzyh73@163.com08602767813154

Backup ContactJianyin Huang, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026