NCT07459101Recruiting
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
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 10 Sept 2025
- Primary completion date
- 31 Oct 2029
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Glioblastoma
- NCT number
- NCT07459101
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 10 Sept 2025 to the primary completion date, 31 Oct 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior therapeutic cranial irradiation
Other illness
- 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
Age
- 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
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Health Sciences Centre - Odette Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.