recurrence of high grade glioblastoma MedDRA version: 9.1 Level: LLT Classification code 10018336 Term: Glioblastoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: age 18-75, life expectance almost 3 months, grade 3 or 4 histological diagnosis of recurrent glioblastoma after surgical and/or radio/chemotherapy approach, untreated pts with anthracycline, Karnofsky >70 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previous anthracycline based therapy, heart failure, RT and CHT finishes 3 weeks before study start
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: PFS% at 6 months;Secondary Objective: PFS (time), response rate, safety, overall survival;Primary end point(s): Survival | — |
Countries
Italy