UNIty-Based MR-Linac Guided Adaptive RadioThErapy for High GraDe Glioma-4

Recruiting now · Not applicable

Conditions studied: Glioblastoma (GBM), Astrocytoma, Grade IV

In brief

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

Key facts

Study ID

NCT07459101

Run by

Sunnybrook Health Sciences Centre

People needed

60

Starts

2025-09-10

Expected to finish

2030-10-01

Last updated by the study team

2026-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• ECOG performance status of 0, 1 or 2
• Sufficient estimated glomerular filtration rate (eGFR) of ≥ 30 mL/ min/1.73 m2 to allow administration of gadolinium-based contrast agent; patients with eGFR < 30 mL/min/1.73 m2 not on dialysis may be allowed on the study after discussion of risks and benefits and approval by study neuroradiologist(s)
• Completed written informed consent
• Patient must be accessible for treatment and follow-up
• Patients with multifocal or multicentric disease will be allowed per the discretion of the radiation oncologist

You may not qualify if…

• 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
• Inability to tolerate immobilization in a head thermoplastic mask
• Patients > 140 kg and/or a circumference > 60 cm (MRI scanner weight and bore size limits)
• Prior therapeutic cranial irradiation
• Leptomeningeal dissemination of disease
• History of other malignancies with the exception of adequately treated non-melanoma skin cancer, or curatively treated other solid tumours with no evidence of disease for ≥ 2 years
• Patients with any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol

Where it is running

• Sunnybrook Health Sciences Centre - Odette Cancer Centre — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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