NCT06186440

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 Cisplatin plus Temozolomide 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 P75+ for phase_1

Timeline
Completed

Started Jan 2024

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

December 15, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

December 15, 2023

Last Update Submit

December 28, 2023

Conditions

Glioblastoma Multiforme of Brain

Keywords

Glioblastoma MGMT promoter unmethylation

Outcome Measures

Primary Outcomes (1)

  • Overall survival

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

    1 YEAR

Secondary Outcomes (1)

  • PFS

    6 months

Study Arms (2)

Experimental

EXPERIMENTAL

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

Drug: Cisplatin Plus Temozolomide

Temozolomide

ACTIVE COMPARATOR

Temozolomide 150-200mg/m2 days 1-5

Drug: Temozolomide

Interventions

Cisplatin Plus TemozolomideDRUG

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

Experimental
TemozolomideDRUG

Temozolomide

Temozolomide

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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

CisplatinTemozolomide

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsDacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2023

First Posted

January 2, 2024

Study Start

January 1, 2024

Primary Completion

December 1, 2024

Study Completion

January 1, 2025

Last Updated

January 2, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share