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

NCT06888817 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2026-02-25

No results posted yet for this study

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.

Conditions

  • Radiation Necrosis
  • High Grade Glioma (III or IV)
  • Brain Metastasases
  • Radiation Toxicity
  • Radiation Effect
  • Radiation Injury
  • Radiation Injuries

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

Sponsors & Collaborators

  • UMC Utrecht

    collaborator OTHER

  • Amsterdam UMC

    collaborator OTHER

  • Medical Center Haaglanden

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Dieta Brandsma, MD, PhD · Netherlands Cancer Institute - Antoni van Leeuwenhoek

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-19
Primary Completion
2028-07-31
Completion
2030-07-31

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06888817 on ClinicalTrials.gov