Trial intelligence / Profile preview

BZ-SRS with Bevacizumab in Recurrent GBM

NCT02120287Phase 2

Key facts

Status: Completed
Start: May 2014
Primary completion: Mar 2018
Countries: 1
Sponsor: Ajay Niranjan
Modality: Monoclonal Antibodies

Drugs: bevacizumab
Conditions: glioblastoma multiforme (GBM)

Overview

Phase 2, open-label, single-arm trial of bevacizumab in glioblastoma multiforme (GBM), sponsored by Ajay Niranjan. Primary endpoint: Overall Survival up to 2 years. Started May 2014; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

BZ-SRS with Bevacizumab
Border Zone Stereotactic Radiosurgery + Bevacizumab

Who it enrols

Adult patients with recurrent or progressive glioblastoma multiforme (WHO grade IV) who have received prior first-line treatment with surgery/biopsy, fractionated radiotherapy, and temozolomide. Patients must have a KPS >= 60 and life expectancy >= 12 weeks.

Endpoints

Primary

Overall SurvivalUp to 2 years

Secondary

Progression-free Survival6 months
6-month Overall Survival6 months
Central Nervous System Toxicity6 months post-SRS
Tumor ResponseUp to 2 years
Potential Value of Magnetic Resonance SpectroscopyPrior to radiosurgery
Karnofsky Performance Status
Barthel's Index of Activities of Daily Living Assessment8 weeks
Center for Epidemiological Studies Depression Scale8 weeks

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