NCT02490878

Corticosteroids + Bevacizumab vs. Corticosteroids + Placebo (BEST) for Radionecrosis After Radiosurgery for Brain Metastases

Randomized Phase II Study: Corticosteroids + Bevacizumab vs. Corticosteroids + Placebo (BEST) for Radionecrosis After Radiosurgery for Brain Metastases

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II study aims to investigate whether the addition of bevacizumab to standard corticosteroid therapy results in greater improvement in symptoms and less treatment-induced symptoms compared with standard corticosteroid therapy for patients with symptomatic brain radionecrosis following radiosurgery. It is hypothesized that the addition of bevacizumab to standard care corticosteroids will reduce treatment-induced toxicities and improve neurologic impairments in patients with brain radionecrosis following radiosurgery for brain metastases.

Detailed description

This is a randomized double-blinded phase II study of corticosteroids with bevacizumab vs. corticosteroids with placebo for brain radionecrosis following radiosurgery for brain metastases. This is a two-arm clinical trial with parallel group design for longitudinal quality of life endpoint. Patients will be stratified according to age (≤ 65 years vs. \> 65 years), pathological confirmation of necrosis (yes vs. no), MDASI-BT mean global score (symptom + interference scores) ( \< 4.0 vs. \> 4.0) and prior whole brain radiotherapy (yes vs. no). The primary and secondary objectives are detailed below. Primary Objective: To investigate whether the addition of bevacizumab to standard corticosteroid therapy results in greater improvement in symptoms (clinical and patient-reported symptom improvement associated with radionecrosis and less radionecrosis treatment-induced symptoms) compared with standard corticosteroid therapy. Secondary Objectives: 1. To evaluate the toxicity profile associated with bevacizumab and corticosteroid therapy. 2. To compare self-reported health related quality of life (HRQOL) using LASA, Dexamethasone Symptoms Questionnaire-Chronic (DSQ-C), and MDASI-BT symptom and interference score between treatment arms. 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 and correlate steroid requirement with DSQ-C and MDASI-BT scores. Patient event monitoring will occur every 2 months after treatment up to 6 months. Then event monitoring will occur up to one year.

Conditions

• Radionecrosis
• Brain Metastases

Interventions

Type	Name	Description
DRUG	bevacizumab	IV
DRUG	corticosteroids	IV
OTHER	placebo	IV

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-02-01
• Completion: 2022-12-15
• First posted: 2015-07-07
• Last updated: 2023-03-23
• Results posted: 2021-08-06

Locations

341 sites across 2 countries: United States, Canada