NCT05720078 UNIty-Based MR-Linac Guided Adaptive RadioThErapy for High GraDe Glioma-3 (UNITED-3)

Eligibility & Interventions

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This trial targets 70 participants in total. It began in 2023-04-01 with a primary completion date of 2026-04-30.

Brief Summary

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

Eligibility Criteria

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

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