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Clinical Trials in Canada / NCT07459101
Recruiting Not applicable

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

NCT07459101 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2025-09-10
Last updated
2026-03-09

Condition(s) studied

Glioblastoma (GBM)Astrocytoma, Grade IV

Investigational drug(s) / intervention(s)

Dose painting + Reduced Margins

Dose painting + Reduced Margins: Reduced margins using a dose painting approach

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sunnybrook Health Sciences Centre - Odette Cancer Centre Toronto Ontario Recruiting

More Sunnybrook Health Sciences Centre trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07459101 on ClinicalTrials.gov ↗ ← All trials in Canada