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Etoposide Plus Cisplatin Compared With Temozolomide in Patients With Glioblastoma

Z

Zhongnan Hospital

Status and phase

Not yet enrolling
Phase 2

Conditions

MGMT-Unmethylated Glioblastoma

Treatments

Drug: Etoposide Plus Cisplatin

Study type

Interventional

Funder types

Other

Identifiers

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 Etoposide plus Cisplatin 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 70 years old

Volunteers

No Healthy Volunteers

Inclusion 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.
  • 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

60 participants in 2 patient groups

Etoposide Plus Cisplatin group
Experimental group
Description:
Etoposide 100mg/m2 d1-5 Cisplatin 20mg/mCisplatin d1-5
Treatment:
Drug: Etoposide Plus Cisplatin
Temozolomide group
No Intervention group
Description:
Temozolomide 150-200mg/m2 d1-5

Trial contacts and locations

0

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Central trial contact

Yahua Zhong, Phd; Jianyin Huang, MD

Data sourced from clinicaltrials.gov

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