UNIty-Based MR-Linac Guided Adaptive RadioThErapy for High GraDe Glioma-4
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunnybrook Health Sciences Centre
About this trial
This study builds on the results of prior studies (UNITED and UNITED-3). The goal of UNITED-4 is to test whether an adaptive radiation therapy (RT) therapy approach ('dose painting'), with reduced margins, impacts approach in participants with glioblastoma impacts local control compared to standard non-adaptive RT approach. The main questions of the study are to see how this adaptive RT approach with reduced margins compares to standard RT in terms of:
* Local control * Overall and progression-free survival * Patterns of failure * Toxicity, Neurological Function, and Quality of Life * Longitudinal imaging features
Eligibility criteria
Qualifiers
Histopathologically confirmed, based on biopsy or surgical resection, glioblastoma or WHO grade 4 astrocytoma (IDH wild type or mutant)
Deemed clinically appropriate for concurrent chemoradiotherapy (with temozolomide) with definitive/radical intent
Biopsy or surgical resection performed ≤ 12 weeks prior to study entry
Expected survival ≥ 12 weeks
Disqualifiers
Contraindications to MRI examination as per standard MRI screening policy
Contraindication to Gadolinium-based contrast media
Enhancing disease involving any part of the brainstem on post-gadolinium T1-weighted MRI imaging for patients being treated using the short-course 15-fraction regimen
Inability to lie flat in a supine position for at least 30 minutes
Trial design
Treatments tested in this trial
- Dose painting + Reduced Margins
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov