Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma, Grade IV | Astrocytoma | CURATED_BROADER | 0.80 |
| Glioblastoma (GBM) | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dose painting + Reduced Margins | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adaptive RT (Dose Painting)
- description
- Participants in this arm will have radiation (with reduced margins) delivered using a dose painting approach
- interventionNames
- Radiation: Dose painting + Reduced Margins
Primary outcomes (1)
- measure
- Disease worsening at 6 months
- timeFrame
- From RT start to 6 months after RT
Secondary outcomes (7)
- measure
- Overall survival
- timeFrame
- Throughout study participation, anticipated 0-25 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available