Etoposide Plus Cisplatin Compared With Temozolomide in Patients With Glioblastoma

Phase 2

Not yet recruiting

• Conditions: MGMT-Unmethylated Glioblastoma
• Interventions: Drug: Etoposide Plus Cisplatin

• Registration Number: NCT05694416
• Lead Sponsor: Zhongnan Hospital

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

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-12
• Last Update Submitted: 2023-01-12
• Study First Posted: 2023-01-23
• Last Update Posted: 2023-01-23
• Study Start: 2023-02-01
• Primary Completion: 2024-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Etoposide Plus Cisplatin group	Etoposide Plus Cisplatin	Etoposide 100mg/m2 d1-5 Cisplatin 20mg/mCisplatin d1-5

Primary Outcome Measures

Name	Time	Method
OVER SURVIVAL	2 YEARS	The length of time from the date of diagnosis to death from cancer

Secondary Outcome Measures

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