RecruitingNot ApplicableNCT07459101

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

UNIty-Based MR-Linac Guided Adaptive RadioThErapy for High GraDe Glioma-4 (UNITED-4): Prospective Evaluation of FLAIR-Guided Clinical Target Volume Reduction

Sponsor

Sunnybrook Health Sciences Centre

Enrollment

60 participants

Start Date

Sep 10, 2025

Study Type

INTERVENTIONAL

Conditions

Glioblastoma (GBM)Astrocytoma, Grade IV

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses an advanced form of radiotherapy called MR-linac guided adaptive radiotherapy—which combines a high-powered radiation machine with real-time MRI imaging so the radiation is continuously adapted to the exact shape and position of the tumor—for patients with glioblastoma or high-grade brain tumors. The goal is to deliver radiation more precisely to spare healthy brain tissue. **You may be eligible if...** - You have been diagnosed with glioblastoma or a WHO grade 4 brain tumor, confirmed by biopsy or surgery - Your surgery or biopsy was done within 12 weeks before study entry - Your doctors have recommended standard treatment (radiation plus temozolomide chemotherapy) - You are in reasonable physical condition (ECOG 0–2) and expected to survive at least 12 weeks **You may NOT be eligible if...** - You have a contraindication to MRI (such as certain metal implants) - You are allergic to the gadolinium contrast dye used in MRI - You cannot lie flat on your back for at least 30 minutes or tolerate a head immobilization mask - You weigh more than 140 kg or have a very large body circumference - You have previously received brain radiation therapy - You have another active cancer (with some exceptions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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