Active — Not RecruitingNot Applicable

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

Canada70 participantsStarted 2023-04-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT05720078

SponsorSunnybrook Health Sciences Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-30

View on ClinicalTrials.gov More Glioblastoma Multiforme, Adult trials