Skip to content

Phase II, single-arm, open-label interventional clinical trial to evaluate the role of anthracycline infusion after radiotherapy (RT) in pediatric and young adult patients with glioblastoma (pGBM)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519135-41-00
Acronym
pGBM-WBRT/DOX2020
Enrollment
20
Registered
2025-01-13
Start date
2022-06-21
Completion date
Unknown
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma

Brief summary

The primary safety endpoint is defined as: - Time to early discontinuation of the experimental treatment with Doxorubicin - Percentage of subjects with Serious Adverse Events (SAE) that lead to withdrawal from the study - Percentage of SAE - Mortality due to adverse events - Proportion of early discontinuation of the experimental treatment with Doxorubicin

Detailed description

Event-free survival (EFS) that is the time between the date of enrollment and the date of occurrence of one of the following events: disease progression, any new lesions, clinical deterioration due to the tumor; failure to return for evaluation following death or deterioration of conditions., Overall survival (OS) defined as the time between the date of enrollment and the date of death from any cause, Progression-free survival (PFS) defined as the time between the date of enrollment and the date of progression according to modified RANO criteria, Proportion of treatment responder (CR, complete responder; PR, partial responder; SD, stable disease; PD, disease progression) according to modified RANO criteria

Interventions

DRUGTEMOZOLOMIDE
DRUGDOXORUBICIN

Sponsors

Azienda Ospedaliera Universitaria Meyer IRCCS
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The primary safety endpoint is defined as: - Time to early discontinuation of the experimental treatment with Doxorubicin - Percentage of subjects with Serious Adverse Events (SAE) that lead to withdrawal from the study - Percentage of SAE - Mortality due to adverse events - Proportion of early discontinuation of the experimental treatment with Doxorubicin

Secondary

MeasureTime frame
Event-free survival (EFS) that is the time between the date of enrollment and the date of occurrence of one of the following events: disease progression, any new lesions, clinical deterioration due to the tumor; failure to return for evaluation following death or deterioration of conditions., Overall survival (OS) defined as the time between the date of enrollment and the date of death from any cause, Progression-free survival (PFS) defined as the time between the date of enrollment and the date of progression according to modified RANO criteria, Proportion of treatment responder (CR, complete responder; PR, partial responder; SD, stable disease; PD, disease progression) according to modified RANO criteria

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026