UNIty-Based MR-Linac Guided Adaptive RadioThErapy for High GraDe Glioma-4
Key facts
- Where
- Toronto, CanadaSee the site
Where in Canada
- Sunnybrook Health Sciences Centre - Odette Cancer CentreToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sunnybrook Health Sciences Centre
- Trial code
- NCT07459101
- Record updated
- 23 October 2026
- Original description
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:Read full original descriptionShow less
UNIty-Based MR-Linac Guided Adaptive RadioThErapy for High GraDe Glioma-4 (UNITED-4): Prospective Evaluation of FLAIR-Guided Clinical Target Volume Reduction
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
Inclusion: 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.
Exclusion: Prior therapeutic cranial irradiation; 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; Leptomeningeal dissemination of disease; Patients with any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol; 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; Contraindications to MRI examination as per standard MRI screening policy; Contraindication to Gadolinium-based contrast media; 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).