Etoposide Plus Cisplatin Compared With Temozolomide in Patients With Glioblastoma

Sponsor

Zhongnan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05694416

Collaborator

(none)

Enrollment

Arms

24.9

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
MGMT-Unmethylated Glioblastoma	Drug: Etoposide Plus Cisplatin	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Etoposide Plus Cisplatin group Etoposide 100mg/m2 d1-5 Cisplatin 20mg/mCisplatin d1-5	Drug: Etoposide Plus Cisplatin Etoposide Plus Cisplatin ivdrip d1-5 Other Names: EP
No Intervention: Temozolomide group Temozolomide 150-200mg/m2 d1-5

Arm

Intervention/Treatment

Experimental: Etoposide Plus Cisplatin group

Etoposide 100mg/m2 d1-5 Cisplatin 20mg/mCisplatin d1-5

Drug: Etoposide Plus Cisplatin

Etoposide Plus Cisplatin ivdrip d1-5

Other Names:

No Intervention: Temozolomide group

Temozolomide 150-200mg/m2 d1-5

Outcome Measures

Primary Outcome Measures

OVER SURVIVAL [2 YEARS]
The length of time from the date of diagnosis to death from cancer

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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