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

Zhongnan Hospital

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Glioblastoma Multiforme of Brain

Treatments: Drug: Temozolomide; Drug: Cisplatin Plus Temozolomide

Study type: Interventional

Funder types: Other

Identifiers

NCT06186440

G32540

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 75, 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Experimental

Experimental group

Description:

Cisplatin 20mg/m2 Cisplatin days 1-5 plus Temozolomide 150-200mg/m2 days 1-5

Treatment:

Drug: Cisplatin Plus Temozolomide

Temozolomide

Active Comparator group

Description:

Temozolomide 150-200mg/m2 days 1-5

Treatment:

Drug: Temozolomide