Etoposide Plus Cisplatin Compared With Temozolomide in Patients With Glioblastoma

January 12, 2023 updated by: Zhongnan Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jianyin Huang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Etoposide Plus Cisplatin group
Etoposide 100mg/m2 d1-5 Cisplatin 20mg/mCisplatin d1-5
Drug: Etoposide Plus Cisplatin
Etoposide Plus Cisplatin ivdrip d1-5
Other Names:
  • EP
No Intervention: Temozolomide group
Temozolomide 150-200mg/m2 d1-5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OVER SURVIVAL
Time Frame: 2 YEARS
The length of time from the date of diagnosis to death from cancer
2 YEARS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 1 year
the length of time after primary treatment for glioblastoma ends that the patient survives without any progression of glioblastoma.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongnan Hospital

Investigators

  • Study Chair: Jianyin Huang, MD, Wuhan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUTURE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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