Etoposide Plus Cisplatin Compared With Temozolomide in Patients With Glioblastoma

NCT ID: NCT05694416

Last Updated: 2023-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2025-03-01

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

Conditions

MGMT-Unmethylated Glioblastoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Etoposide Plus Cisplatin group

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

Group Type: EXPERIMENTAL

Etoposide Plus Cisplatin

Intervention Type: DRUG

Etoposide Plus Cisplatin ivdrip d1-5

Temozolomide group

Temozolomide 150-200mg/m2 d1-5

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Etoposide Plus Cisplatin

Etoposide Plus Cisplatin ivdrip d1-5

Intervention Type: DRUG

Other Intervention Names

EP

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongnan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianyin Huang, MD

Role: STUDY_CHAIR

Wuhan University

Central Contacts

Yahua Zhong, Phd

Role: CONTACT

doctorzyh73@163.com

08602767813154

Jianyin Huang, MD

Role: CONTACT

Other Identifiers

FUTURE

Identifier Type: -

Identifier Source: org_study_id