AzTrials
AzTrials

Glioblastoma Multiforme, AdultUNITED-3NCT05720078

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

A study testing Adaptive, two-phase RT in people with Glioblastoma Multiforme, Adult, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma Multiforme, Adult
What is being tested?
Adaptive, two-phase RT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteCanada
Study dates
1 Apr 2023to 30 Apr 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 16Show fewer
  • 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/1.73 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

Who cannot join

  • Contraindications to MRI examination as per standard MRI screening policy
  • Contraindication to Gadolinium-based contrast media
  • 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
  • Prior therapeutic cranial irradiation
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N3M5

Other trials in Canada

About this study

Official title: UNIty-Based MR-Linac Guided Adaptive RadioThErapy for High GraDe Glioma-3 (UNITED-3): Applying a Two Phase, Personalized Margin, Reduced Clinical Target Volume Approach

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
Read the detailed description

Glioblastoma (GBM) is a high grade glioma (brain tumor) that is treated with surgery or biopsy followed by radiotherapy (RT) given daily over 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 with a two-phase approach to test the impact on local control of the visible tumor compared to the large volumes used with standard non-adaptive RT, as well as impacts on neurocognitive function and quality of life.

Being tested
Adaptive, two-phase RT
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adaptive, two-phase RTRadiation

    Participants in this arm will be treated with an adaptive, two-phase radiation therapy approach

Study groups in NCT05720078
Study groupRoleWhat they receive
Adaptive, two-phase RTExperimentalNot described
Receives: Radiation: Adaptive, two-phase RT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of marginal failure (if 20-80% of the recurrent GTV (rGTV) falls within the 95% isodose line)

    Measured: Through study completion, anticipated 6-12 months

Secondary outcomes (9)

  1. Overall survival

    Measured: Through study completion, anticipated 6-24 months

  2. Progression-free survival

    Measured: Through study completion, anticipated ~5 months

  3. Rate of local control, in accordance with RANO-HGG criteria

    Measured: Through study completion, anticipated ~5 months

  4. Patterns of failure

    Measured: Through study completion, anticipated 6-24 months

  5. Rate of toxicity

    Assessed using the Radiation Therapy Oncology Group (RTOG) acute toxicity scale, which assesses acute toxicity using a scale of 0-5, and late toxicity using a scale of 1-4. In both scales, a higher score means a worse outcome.

    Measured: Through study completion, anticipated 6-24 months

  6. Health-related Quality of Life

    Assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 to measure quality of life

    Measured: Through study completion, anticipated 6-24 months

  7. Changes in neurologic function

    Assessed through the Neurologic Assessment in Neuro-Oncology (NANO) scale

    Measured: Through study completion, anticipated 6-24 months

  8. Adaptive Radiation Dosimetry

    Measured: 6 weeks

  9. Functional Imaging Kinetics as a Correlate of Treatment Response

    Measured: Through study completion, anticipated 12-24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2023
  2. Study start1 Apr 2023
  3. Primary completion30 Apr 2026
  4. Study completion30 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05720078
Sponsor's protocol ID
UNITED-3
Acronym
UNITED-3
Status last verified
Jun 2026
First submitted
6 Jan 2023
Last updated
1 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Adaptive, two-phase RT in people with Glioblastoma Multiforme, Adult, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of marginal failure (if 20-80% of the recurrent GTV (rGTV) falls within the 95% isodose line) (time frame: Through study completion, anticipated 6-12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05720078.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in