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

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

Trial Details

NCT ID
NCT06888817
Phase
PHASE3
Sponsor
The Netherlands Cancer Institute
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • Bevacizumab
  • Dexamethasone
Locations (sample)
  • Amsterdam, Netherlands|52.37403,4.88969
  • Amsterdam, Netherlands|52.37403,4.88969
  • Leiden, Netherlands|52.15833,4.49306
  • The Hague, Netherlands|52.07667,4.29861
  • Utrecht, Netherlands|52.09083,5.12222

Key Eligibility Criteria

  • Inclusion all patients (both HGG and BM):
  • Age ≥ 18 years old
  • First episode of sCRN ≥ 3 months after completion of focal (re-)irradiation, as determined by the local Multidisciplinary Neuro-Oncology Board. A c…
  • KPS score ≤ 90 and a minimum loss of two points in at least one domain of the NANO scale as compared to the maximum score of at that domain due to …

For full eligibility, visit ClinicalTrials.gov.

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