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Cisplatin Plus Temozolomide C...

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

Last Updated: 2024-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-01-01

Brief Summary

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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

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Detailed Description

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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

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Glioblastoma Multiforme of Brain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental

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

Group Type EXPERIMENTAL

Cisplatin Plus Temozolomide

Intervention Type DRUG

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

Temozolomide

Temozolomide 150-200mg/m2 days 1-5

Group Type ACTIVE_COMPARATOR

Temozolomide

Intervention Type DRUG

Temozolomide

Interventions

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