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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Sunnybrook Health Sciences Centre - Odette Cancer Centre
RECRUITING
Toronto
Contact Information
Primary
Hanbo Chen, MD
hanbo.chen@sunnybrook.ca
416-480-6100
Time Frame
Start Date: 2025-09-10
Estimated Completion Date: 2030-10
Participants
Target number of participants: 60
Treatments
Experimental: Adaptive RT (Dose Painting)
Participants in this arm will have radiation (with reduced margins) delivered using a dose painting approach
Sponsors
Leads: Sunnybrook Health Sciences Centre

This content was sourced from clinicaltrials.gov