Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07459101

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

Led by Sunnybrook Health Sciences Centre · Updated on 2026-03-09

60

Participants Needed

1

Research Sites

263 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histopathologically confirmed glioblastoma or WHO grade 4 astrocytoma (IDH wild type or mutant) based on biopsy or surgical resection
  • Suitable for concurrent chemoradiotherapy with temozolomide with definitive intent
  • Biopsy or surgical resection performed within 12 weeks before study entry
  • Expected survival of at least 12 weeks
  • ECOG performance status of 0, 1, or 2
  • Estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m2 or higher for safe gadolinium contrast use; exceptions may be allowed after specialist approval
  • Provided written informed consent
  • Accessible for treatment and follow-up
  • Patients with multifocal or multicentric disease may be included at the radiation oncologist's discretion
Not Eligible

You will not qualify if you...

  • Contraindications to MRI examination
  • Contraindication to gadolinium-based contrast media
  • Enhancing disease involving any part of the brainstem on MRI for patients on the short-course 15-fraction regimen
  • Unable to lie flat in a supine position for at least 30 minutes
  • Unable to tolerate immobilization in a head thermoplastic mask
  • Weight over 140 kg and/or circumference over 60 cm (MRI scanner limits)
  • Prior therapeutic cranial radiation
  • Leptomeningeal dissemination of disease
  • History of other malignancies except treated non-melanoma skin cancer or other solid tumors with no evidence of disease for 2 years or more
  • Conditions preventing compliance with the study protocol (e.g., psychological, geographical)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sunnybrook Health Sciences Centre - Odette Cancer Centre

Toronto, Ontario, Canada, M4N3M5

Actively Recruiting

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Research Team

H

Hanbo Chen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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