💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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