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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06186440

Acronym

Glioblastoma

Enrollment

Registered

2024-01-02

Start date

2024-01-01

Completion date

2025-01-01

Last updated

2024-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma Multiforme of Brain

Keywords

Glioblastoma MGMT promoter unmethylation

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 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

Interventions

DRUGCisplatin Plus Temozolomide

Cisplatin Plus Temozolomide . Cisplatin 20mg/mCisplatin days 1-5

DRUGTemozolomide

Temozolomide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Overall survival	1 YEAR	The length of time from the date of diagnosis to death from cancer

Secondary

Measure	Time frame	Description
PFS	6 months	the length of time after primary treatment for glioblastoma ends that the patient survives without any progression of glioblastoma

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026