NCT05694416

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 Etoposide plus Cisplatin and Temozolomide in patients with MGMT gene promoter unmethylation glioblastoma.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

1.1 years

First QC Date

January 12, 2023

Last Update Submit

January 12, 2023

Conditions

MGMT-Unmethylated Glioblastoma

Keywords

Etoposide Plus CisplatinTemozolomideMGMT-Unmethylated Glioblastoma

Outcome Measures

Primary Outcomes (1)

  • OVER SURVIVAL

    The length of time from the date of diagnosis to death from cancer

    2 YEARS

Secondary Outcomes (1)

  • PFS

    1 year

Study Arms (2)

Etoposide Plus Cisplatin group

EXPERIMENTAL

Etoposide 100mg/m2 d1-5 Cisplatin 20mg/mCisplatin d1-5

Drug: Etoposide Plus Cisplatin

Temozolomide group

NO INTERVENTION

Temozolomide 150-200mg/m2 d1-5

Interventions

Etoposide Plus CisplatinDRUG

Etoposide Plus Cisplatin ivdrip d1-5

Also known as: EP
Etoposide Plus Cisplatin group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

EtoposideCisplatin

Intervention Hierarchy (Ancestors)

PodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Jianyin Huang, MD

    Wuhan University

    STUDY CHAIR

Central Study Contacts

Yahua Zhong, Phd

CONTACT

08602767813154doctorzyh73@163.com

Jianyin Huang, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 23, 2023

Study Start

February 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2025

Last Updated

January 23, 2023

Record last verified: 2023-01