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New treatment option for Glioblastoma (GBM)
Official title UNIty-Based MR-Linac Guided Adaptive RadioThErapy for High GraDe Glioma-4
ClinicalTrials.gov ID: NCT07459101
What this study is testing
- What it's testing
- 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.
- Time commitment: about 24 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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)
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.