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UNIty-Based MR-Linac Guided AdapTive RadiothErapy for High GraDe Glioma: a Phase 2 Trial

UNIty-Based MR-Linac Guided AdapTive RadiothErapy for High GraDe Glioma: a Phase 2 Trial (UNITED Trial)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04726397
Acronym
UNITED
Enrollment
108
Registered
2021-01-27
Start date
2021-03-29
Completion date
2024-05-15
Last updated
2024-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma Multiforme

Brief summary

Glioblastoma (GBM) is a high grade glioma (brain tumor) that is treated with surgery or biopsy followed by radiotherapy (RT) given daily over 3 or 6 weeks with or without an oral chemotherapy. Radiation is targeted to the visible residual tumor on magnetic resonance imaging (MRI) images plus a large margin of 15 to 30 mm to account for possible cancer cells outside the visible tumor and for potential growth or shifts in tumor position throughout the prolonged RT course. Standard RT uses MRI to create a reference plan (with large margins) and treats that same volume every day. This exposes a large amount of healthy brain tissue to radiation leading to toxicity and reduced quality of life. A new technology, the MR-Linac, combines an MRI scanner and a Linac (radiation delivery machine) into one unit. This allows for adaptive RT by obtaining an updated MRI scan each day just prior to treatment, adapting the RT plan to take into account any changes in the tumor or the patient's anatomy on that given day. This allows for a smaller (5 mm) margin on the visible tumor as its position can be tracked daily. The goal of this study is to use adaptive RT with small margins to demonstrate that the local control of the visible tumor is not compromised compared to the large volumes used with standard non-adaptive RT, while determining whether smaller margins lead to decreased radiation toxicity and therefore improved quality of life by minimizing radiation exposure.

Interventions

RADIATIONReduced margin adaptive radiotherapy

Reduced (5 mm) clinical target volume margin with weekly contrast-enhanced adaptive radiation on the MR-Linac treatment machine

Sponsors

Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients aged 18 years and older * Histopathologically confirmed malignant glioma of the brain, Grade 4 (GBM) * Eligible for RT in 15 or 30 fractions with or without chemotherapy (temozolamide) * Expected survival greater than 12 weeks * WHO performance status less than or equal to 2 * Able to converse and answer questionnaires in English language * Has a maximum final planning volume less than 150 cm3

Exclusion criteria

* Contraindications to MRI examination as per standard MRI screening policy * Contraindication to Gadolinium-based contrast media * Unable to lie flat in a supine position for 30 minutes * Poor baseline kidney function with an eGFR \< 60 mL/min * Unable to tolerate immobilization in a head thermoplastic mask * Patients \>140 kg and/or a circumference \>60cm * Previous cranial irradiation * Infratentorial tumour extent, multifocal of leptomeningeal disease * Unable to give informed consent

Design outcomes

Primary

MeasureTime frameDescription
Imaging-detected tumor recurrence at the edge of the radiation volume (marginal failure)Within 1 year from end of radiationThe presence of tumor on contrast-enhanced MRI between 1-2 cm from the edge of the treated radiation volume (commonly known as a marginal failure) within 1 year from radiation.

Secondary

MeasureTime frameDescription
Tumor volume changes during RT6 weeksChange in gross tumor volume (%) from start to end of RT
Acute radiation toxicity based on RTOG/EORTC Common Toxicity Criteria6 weeksGrades 1-4 toxicity during RT in the following categories: skin, CNS, eye, ear, and hematological
Quality of life changes based on EORTC QLQ-C301 yearChanges in quality of life during and after RT based on accepted EORTC cancer quality of life instruments administered each week on RT, 1 month post RT, and every 3 months subsequently
Dexamethasone usage10 weeksAmount of dexamethasone required during RT
Quality of life based on EORTC QLQ-BN201 yearChanges in quality of life during and after RT based on accepted EORTC brain tumor quality of life instruments administered each week on RT, 1 month post RT, and every 3 months subsequently

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026