newly diagnosed Glioblastoma multiforme WHO Grade IV
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
Pharmaceutical Form: Capsule, hard
Sponsors
Klinik und Poliklinik für Neurologie der Universität Regensburg am Bezirksklinikum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histopathologically confirmed glioblastoma multiforme (GBM, WHO grade IV) • Age: >= 18 and = 70% • Stable, non-increasing dose of corticosteroids 2 weeks before randomization • Adequate hematological, renal and hepatic function according to all of the following laboratory values (to be performed within 14 days, inclusive, prior to randomization): • WBC >= 3000/microliter, Hb >= 10 g/dl • Platelets >= 100000/microliter; • Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • prior chemotherapy • prior radiotherapy to the brain • Karnofsky performance index < 70%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the safety and activity of concomitant and adjuvant Temozolomide in combiantion with pegylated liposomal doxorubicin in patients with glioblastoma WHO grade IV;Secondary Objective: Evaluation of time to progression (TTP) Evaluation of overall survival (OS) Evaluation of response rate Evaluation of safety profile Evaluation of quality of life (QoL);Primary end point(s): Evaluation of progession free survival after 12 months from start of treatment (PFS-12) | — |
Countries
Austria
Outcome results
None listed