Bevacizumab compared with steroids for brain damage caused by radiation
Official title: Bevacizumab Versus Corticosteroids as First-line Treatment in Patients With Symptomatic Cerebral Radiation Necrosis After Radiation for High-grade Glioma or Brain Metastases
Status: Recruiting. It is looking for patients now. Talk to your care team about whether it fits you.
The trial team last updated this record on .
The short version
This study tests whether a drug called bevacizumab works better than steroids as the first treatment for brain swelling and damage caused by radiation.
Read our full plain-language summary
What the trial team says
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.
Key facts
- Registry number
- NCT06888817
- Stage of testing
- Phase 3
- Conditions studied
- Radiation Necrosis, High Grade Glioma (III or IV), Brain Metastasases, Radiation Toxicity, Radiation Effect, Radiation Injury, Radiation Injuries
Where it is running
This trial lists 6 sites.
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Netherlands
- Netherlands Cancer Institute - Antoni van Leeuwenhoek (Amsterdam)
- Amsterdam University Medical Centers, location VUmc and AMC (Amsterdam)
- Leiden University Medical Center (Leiden)
- Maastricht University Medical Center+ (Maastricht)
- Haaglanden Medical Center (The Hague)
- University Medical Center Utrecht (Utrecht)
How to use this
Talk to your care team first. They know your history and can tell you whether this trial is worth your time.
Joining a trial is always your choice. A trial is a test, not a proven treatment. Being in one is not a promise that it will help you.
This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.