Italy embarks on an innovative journey to combat high-grade meningiomas with the initiation of the MIRAGE trial, aiming to assess the efficacy of regorafenib in patients who have limited treatment options.
Study Design and Objectives
The MIRAGE trial is a multicenter, open-label, randomized phase 2 study encompassing 94 participants diagnosed with grade 2 or 3 meningioma. These patients have shown disease progression despite undergoing surgery and radiotherapy. The research, spearheaded by the Istituto Oncologico Veneto and IOV-IRCCS, commenced in September 2024 and spans 18 months across 15 neuro-oncology centers in Italy. Participants are evenly split to receive either regorafenib administered orally at 160 mg for three weeks on and one week off, or continue with standard local therapies such as bevacizumab, hydroxyurea, or somatostatin analogs.
Participant Criteria and Endpoints
Eligibility for the trial requires histological confirmation of grade 2 or 3 meningioma based on the WHO 2021 classification, documented disease progression with at least one measurable lesion on baseline MRI, and a WHO performance status of 0-1. The primary goal is to evaluate the six-month progression-free survival rate, while secondary objectives include overall survival, response rates, disease control, safety profiles, and quality of life assessments. Additionally, the study will conduct exploratory analyses to further understand regorafenib’s impact.
– Regorafenib targets multiple pathways implicated in tumor growth
– Potential to offer a new therapeutic option for patients with limited choices
– May influence future guidelines for managing high-grade meningiomas
– Results could pave the way for combination therapies involving RTK inhibitors
The MIRAGE trial represents a pivotal effort in addressing the urgent need for effective treatments for aggressive meningioma cases. By focusing on patients who are ineligible for additional surgery or radiotherapy, the study underscores a commitment to improving survival rates and quality of life through targeted therapies. Should regorafenib demonstrate significant benefits, it could revolutionize the standard care approach, offering hope to those grappling with limited options. The collaborative nature of the trial, involving multiple centers across Italy, enhances its potential impact and the generalizability of its findings. Stakeholders in the neuro-oncology field are keenly watching this trial, anticipating data that could shape future research directions and clinical practices in treating high-grade meningiomas.
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