A221208.

Trial name or title	Randomized phase II study: corticosteroids plus bevacizumab versus corticosteroids plus placebo (BeSt) for radionecrosis after radiosurgery for brain metastases
Methods	Double‐blinded, randomised, placebo‐controlled trial
Participants	Patients with a diagnosis of brain radionecrosis following radiosurgery for brain metastases who remain symptomatic after at least 7 days of corticosteroid therapy. Diagnosis of radionecrosis is based on the presentation of clinical symptoms between 3 and 24 months following radiosurgery along with radiological features including a lesion quotient of < 0.3 and rCBV < 1.5 and PSR > 76%.
Interventions	Bevacizumab: 10 mg/kg IV days 1 and 15 x 4 cycles and corticosteroids (dose adjusted at the discretion of the treating physician) Placebo and corticosteroids: (dose adjusted at the discretion of the treating physician)
Outcomes	Primary objective: to investigate whether the addition of bevacizumab to standard corticosteroid therapy results in greater improvement in symptoms, measured using MD Anderson Symptom Inventory‐Brain Tumor (MDASI‐BT), compared with standard therapy Secondary objectives: (1) to evaluate adverse effects associated with corticosteroids versus bevacizumab; (2) to compare health‐related QoL (HR‐QOL), Dexamethasone Symptoms Questionnaire‐Chronic (DSQ‐C) and interference score from the MDASI‐BT; (3) to compare intracranial progression‐free survival and time to maximum radiographic response between treatment arms; (4) to compare the dose and duration of corticosteroids required between treatment arms Correlative objectives: (1) to explore serum/urine biomarkers that predict for treatment response; (2) to explore early imaging biomarkers that predict for treatment response
Starting date	April 2016
Contact information	Caroline Chung, MD phone: 1‐713‐745‐5422 email: cchung3@mdanderson.org
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