OncoMatch/Clinical Trials/NCT06888817
Bevacizumab Versus Corticosteroids as First-line Treatment in Patients With Symptomatic Cerebral Radiation Necrosis After Radiation for High-grade Glioma or Brain Metastases
Is NCT06888817 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Bevacizumab and Dexamethasone for radiation necrosis.
Treatment: Bevacizumab · Dexamethasone — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Performance status
KPS 0–90
Prior therapy
Must have received: focal (re-)irradiation
First episode of sCRN ≥ 3 months after completion of focal (re-)irradiation
Cannot have received: bevacizumab (bevacizumab)
Exception: allowed if >6 months before diagnosis of sCRN
Prior treatment with bevacizumab <6 months before diagnosis of sCRN
Cannot have received: high dose radiotherapy in the abdomen
Previous, current or planned high dose radiotherapy in the abdomen
Lab requirements
Blood counts
Decreased platelet count < 75x10^9/L
Kidney function
Calculated (Cockcroft-Gault) or measured creatinine clearance <30 mL/min; urine dipstick for proteinuria ≥ 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hours urine collection and must demonstrate ≤ 1 g of protein/24 hr.
Cardiac function
Clinical significant cardiovascular disease (see exclusion criteria for details)
Nephrotic syndrome or abnormal renal function; Calculated (Cockcroft-Gault) or measured creatinine clearance <30 mL/min; urine dipstick for proteinuria ≥ 2+. Decreased platelet count < 75x10^9/L. Clinical significant cardiovascular disease.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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