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

Glioblastoma Multiforme of Brain Clinical Trial

— Glioblastoma  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06186440
• Other study ID #: G32540
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: January 1, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: December 2023
• Source: Zhongnan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme of Brain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	The length of time from the date of diagnosis to death from cancer	1 YEAR
Secondary	PFS	the length of time after primary treatment for glioblastoma ends that the patient survives without any progression of glioblastoma	6 months