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

NCT05720078 | Recruiting

• 1 other identifier: UNITED-3
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Glioblastoma Multiforme, Adult

Outcome Measures

Primary Outcomes (1)

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

  Through study completion, anticipated 6-12 months

Secondary Outcomes (9)

• Overall survival

  Through study completion, anticipated 6-24 months

• Progression-free survival

  Through study completion, anticipated ~5 months

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

  Through study completion, anticipated ~5 months

• Patterns of failure

  Through study completion, anticipated 6-24 months

• Rate of toxicity

  Through study completion, anticipated 6-24 months

Study Arms (1)

Adaptive, two-phase RT

EXPERIMENTAL

Radiation: Adaptive, two-phase RT

Interventions

Adaptive, two-phase RT RADIATION

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

Adaptive, two-phase RT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Jay Detsky, MD

CONTACT

416-480-6100; jay.detsky@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiation Oncology

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: February 9, 2023
• Study Start: April 1, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): April 30, 2028
• Last Updated: May 15, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)