Bevacizumab Versus Corticosteroids as First-line Treatment in Patients With Symptomatic Cerebral Radiation Necrosis After Radiation for High-grade Glioma or Brain Metastases

Recruiting Phase 3 Interventional Study
Radiation Necrosis High Grade Glioma (III or IV) Brain Metastasases Radiation Toxicity Radiation Effect Radiation Injury Radiation Injuries
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
408 (estimated)
Sponsor
The Netherlands Cancer Institute · Other
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About This Trial
Cerebral radiation necrosis (CRN) is a severe complication of high-dose radiation for brain metastases (BM) or glioma, which can potentially cause significant neurologic symptoms leading to serious morbidity and impaired quality of life (QoL). The first-line therapy for symptomatic CRN (sCRN) is corticosteroids, primarily dexamethasone, which often leads to complications, refractory symptoms, and …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Inclusion all patients (both HGG and BM): 1. Age ≥ 18 years old 2. First episode of sCRN ≥ 3 months after completion of focal (re-)irradiation, as determined by the local Multidisciplinary Neuro-Oncology Board. A clear working diagnosis of CRN without evidence of a combination …
Contacts

Danique Laan, MSc

+31 20 512 9111

brains@nki.nl

CONTACT

Dieta Brandsma, MD, PhD

+31 20 512 9111

brains@nki.nl

CONTACT