Recruiting

Adaptive RT

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT07459101

Conditions

Glioblastoma (GBM)

Astrocytoma, Grade IV

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dose painting + Reduced Margins

Study Details

Brief summary:

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

Conditions

Glioblastoma (GBM)

Astrocytoma, Grade IV

Study ID

NCT07459101

Start date

Sep 10, 2025

Status verified date

Oct, 2025

Completion date

Oct, 2030

Anticipated

Primary completion date

Oct, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • ECOG performance status of 0, 1 or 2
  • 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
  • Patients with multifocal or multicentric disease will be allowed per the discretion of the radiation oncologist

Exclusion Criteria:

  • 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
  • Inability to tolerate immobilization in a head thermoplastic mask
  • Patients > 140 kg and/or a circumference > 60 cm (MRI scanner weight and bore size limits)
  • 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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Adaptive RT (Dose Painting)

Participants in this arm will have radiation (with reduced margins) delivered using a dose painting approach

Interventions

Dose painting + Reduced Margins

Reduced margins using a dose painting approach

Primary outcome measure

  • Disease worsening at 6 months [ Time Frame: From RT start to 6 months after RT ]

Central Contacts and Locations

Central contacts

Hanbo Chen, MD

416-480-6100hanbo.chen@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre - Odette Cancer Centre

Recruiting

Toronto, Ontario, Canada, M4N3M5

Contacts

Aimee Theriault

416-480-5000aimee.theriault@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Mar 9, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2026-03-09.