Glioblastoma
Conditions
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
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time 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
| Measure | Time 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