Rationale and design of beatnf2 trial: A clinical trial to assess the efficacy and safety of bevacizumab in patients with neurofibromatosis type 2 related vestibular schwannoma

the BeatNF2 Trial Investigators

Research output: Contribution to journalArticlepeer-review

Abstract

Neurofibromatosis type 2 (NF2) causes bilateral vestibular schwannomas (VSs), leading to deafness. VS is treated by surgery or radiation, but neither treatments prevent hearing loss. Bevacizumab was found to be effective in suppressing the tumor’s growth and may help to improve hearing. We are conducting a randomized, double-blind, multicenter clinical trial to verify the efficacy and safety of bevacizumab in NF2-related VS. The primary objective is to evaluate the efficacy of bevacizumab in improving hearing in the affected ear. One of the secondary objectives is to evaluate bevacizumab’s efficacy in rechallenge treatment in relapsed cases. Sixty patients will randomly receive either bevacizumab or a placebo and will be clinically observed for 48 weeks in the initial intervention phase. In the first half (24 weeks), they will receive either 5 mg/kg of bevacizumab or a placebo drug. In the second half, all patients will receive 5 mg/kg of bevacizumab. If hearing function deteriorated in a patient who had shown improvement during the first phase, a rechallenge dose with bevacizumab would be offered.

Original languageEnglish
Pages (from-to)726-739
Number of pages14
JournalCurrent Oncology
Volume28
Issue number1
DOIs
Publication statusPublished - 02-2021

All Science Journal Classification (ASJC) codes

  • Oncology

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