Clinical trial · Interventional
UNIty-Based MR-Linac Guided Adaptive RadioThErapy for High GraDe Glioma-3 (UNITED-3)
UNIty-Based MR-Linac Guided Adaptive RadioThErapy for High GraDe Glioma-3 (UNITED-3): Applying a Two Phase, Personalized Margin, Reduced Clinical Target Volume Approach
NCT05720078CI-TRIAL-00116441UNITED-3active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The goal of this study is to test whether an adaptive radiation therapy (RT), two-phase 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, two-phase RT approach compares to standard RT in terms of: * Local control * Overall and progression-free survival * Patterns of failure * Toxicity, Neurological Function, and Quality of Life
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme, Adult | Adult Glioblastoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adaptive, two-phase RT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adaptive, two-phase RT
- interventionNames
- Radiation: Adaptive, two-phase RT
Primary outcomes (1)
- measure
- Rate of marginal failure (if 20-80% of the recurrent GTV (rGTV) falls within the 95% isodose line)
- timeFrame
- Through study completion, anticipated 6-12 months
Secondary outcomes (9)
- measure
- Overall survival
- timeFrame
- Through study completion, anticipated 6-24 months
- measure
- Progression-free survival
- timeFrame
- Through study completion, anticipated ~5 months
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 grade 4 astrocytoma, as defined by the World Health Organization (WHO) * Deemed clinically appropriate for long course radiation therapy concurrent with systemic therapy * Biopsy or surgical resection performed ≤ 12 weeks prior to study entry * Adequate hematological, renal and hepatic functions as defined by the following required laboratory values obtained within 14 days prior to study entry: * Absolute granulocyte count (AGC) \> 1.5 x 109/L (1,500 cells/mm3) * Platelet count \> 100x109/L (100,000 cells/mm3) * Serum creatinine \< 1.5 times the upper limit of normal * Total serum bilirubin \< 1.5 times the upper limit of normal * Alanine Aminotransferase (ALT, or formerly serum glutamic-pyruvic transaminase (SGPT)) \< 2.5 times the upper limit of normal * and/or aspartate aminotransferase (AST, or serum glutamic-oxaloacetic transaminase (SGOT)) \< 2.5 times the upper limit of normal * Expected survival ≥ 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * Able (sufficiently fluent in English) and willing to complete quality of life questionnaires; however, inability to complete the questionnaires will not make the patient ineligible for the study * 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 Exclusion Criteria: * 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 * 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
No reference posted for this study.