NCT06186440

Cisplatin Plus Temozolomide Compared With Temozolomide in Patients With MGMT Promotor Unmethylated Glioblastoma

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Zhongnan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 Cisplatin plus Temozolomide 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

• Glioblastoma Multiforme of Brain

Interventions

Type	Name	Description
DRUG	Cisplatin Plus Temozolomide	Cisplatin Plus Temozolomide . Cisplatin 20mg/mCisplatin days 1-5
DRUG	Temozolomide	Temozolomide

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-12-01
• Completion: 2025-01-01
• First posted: 2024-01-02
• Last updated: 2024-01-02