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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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/1.73 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.

Exclusion Criteria:

  • - 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.
  • - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05720078
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sunnybrook Health Sciences Centre
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme, Adult
Additional Details

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.

Arms & Interventions

Arms

Experimental: Adaptive, two-phase RT

Interventions

Radiation: - Adaptive, two-phase RT

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Status

Recruiting

Address

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5

Site Contact

Jay Detsky, MD

[email protected]

416-480-4806