Health TrialsbyHealthPanel

UNIty-Based MR-Linac Guided Adaptive RadioThErapy for High GraDe Glioma-4

ConditionsGlioblastoma (GBM)Astrocytoma, Grade IV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunnybrook Health Sciences Centre

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Dose painting + Reduced Margins

    Radiation

    Reduced margins using a dose painting approach

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Adaptive RT (Dose Painting)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Disease worsening at 6 months

Time frame
From RT start to 6 months after RT

Secondary outcomes

1

Overall survival

Time frame
Throughout study participation, anticipated 0-25 months
2

Type of progression

Whether the progression occurred at local, marginal, or distant location

Time frame
Throughout study participation, anticipated 0-25 months
3

Number of participants with RT-related adverse events as assessed by CTCAE v5.0

Acute (within 3 months of RT completion) and late (\> 3 months of RT completion) effects will be assessed

Time frame
Throughout study participation, anticipated 0-25 months
4

Neurological Function

Will be assessed by your treating doctor, using the Neurological Assessment in Neuro-Oncology (NANO) scale

Time frame
Throughout study participation, anticipated 0-25 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sunnybrook Health Sciences Centre

Lead sponsor

Source ClinicalTrials.gov
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