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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

Study acronym: BRAINS
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoint(s) modified Study sites: 5 to 6 · Eligibility criteria expanded, about 33 words · Secondary endpoints: 17 to 21 · 1 morev6 Show 4 more changesShow less
    • Study sites: 5 to 6
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: 17 to 21
    • Collaborators: 4 to 5

    See this version in full on ClinicalTrials.gov ↗

  2. Site details revised at 2 of 5 sitesv5
  3. Site details revised at 2 of 5 sitesv4
  4. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Apr 2028 to Jul 2028 · Completion date: Apr 2030 to Jul 2030 · Start date changed from estimate of Apr 2025 to Jun 19, 2025 · 1 morev3 Show 4 more changesShow less
    • Primary completion date: Apr 2028 to Jul 2028
    • Completion date: Apr 2030 to Jul 2030
    • Start date changed from estimate of Apr 2025 to Jun 19, 2025
    • Site details revised at 5 of 5 sites
  5. Secondary endpoints: details revised at 1 of 17 entries Site contacts updated at 5 of 5 sites · Study title shortened, about 1 wordv2 Show 2 more changesShow less
    • Site contacts updated at 5 of 5 sites
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06888817
Lead Sponsor The Netherlands Cancer Institute
Collaborators: UMC Utrecht, Amsterdam UMC, Medical Center Haaglanden, Leiden University Medical Center, Maastricht University Medical Center
Conditions Radiation Necrosis, High Grade Glioma (III or IV), Brain Metastasases, Radiation Toxicity, Radiation Effect, Radiation Injury, Radiation Injuries
Enrollment 408 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov