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RECRUITING
NCT06888817
PHASE3

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

Sponsor: The Netherlands Cancer Institute

View on ClinicalTrials.gov

Summary

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 interference with anti-cancer treatment. Since 2017, bevacizumab, an antibody against Vascular Endothelial Growth Factor (VEGF), has been used in a second-line treatment setting for refractory sCRN. A small randomized clinical trial (RCT) has shown that bevacizumab significantly diminishes cerebral edema on MRI and decreases clinical symptoms of sCRN in irradiated glioma patients. Several non-randomized clinical studies demonstrated a beneficial radiological and clinical effect of bevacizumab in patients with sCRN after irradiation for BM. The optimal first-line treatment for sCRN is currently unknown. Effective and safe first-line treatment of sCRN will optimize the patient's well-being and health-related QoL. Furthermore, minimizing corticosteroid use will benefit the clinical treatment options and outcomes of concomitant or future anti-cancer treatment. This phase III multicenter, open-label, randomized clinical trial compares the clinical efficacy of first-line bevacizumab versus standard-of-care dexamethasone for sCRN in patients with high-grade glioma (HGG) or BM.

Official title: Bevacizumab for the Treatment of Cerebral RAdiation Induced NecrosiS (BRAINS) Study: a Multicenter, Open-label, Randomized Clinical Trial to Assess the Clinical Efficacy and Cost-effectiveness of Bevacizumab Versus Corticosteroids as First-line Treatment in Patients With Symptomatic Cerebral Radiation Necrosis After Radiation for High-grade Glioma or Brain Metastases

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

408

Start Date

2025-06-19

Completion Date

2030-07

Last Updated

2026-02-25

Healthy Volunteers

No

Interventions

DRUG

Bevacizumab

Intravenous bevacizumab at a 600 mg flat dose every three weeks for four courses over 12 weeks

DRUG

Dexamethasone

Daily oral dexamethasone followed by a protocol-based tapering dose over 12 weeks

Locations (5)

Netherlands Cancer Institute - Antoni van Leeuwenhoek

Amsterdam, Netherlands

Amsterdam University Medical Centers, location VUmc and AMC

Amsterdam, Netherlands

Leiden University Medical Center

Leiden, Netherlands

Haaglanden Medical Center

The Hague, Netherlands

University Medical Center Utrecht

Utrecht, Netherlands