Adaptive radiation therapy for glioblastoma treatment
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
This study is testing a new type of radiation therapy that adjusts daily based on MRI scans to see if it helps people with glioblastoma live longer and feel better compared to standard radiation therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05720078 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of an adaptive radiation therapy approach using an MR-Linac for patients with glioblastoma. It compares a two-phase adaptive radiation therapy to standard non-adaptive radiation therapy in terms of local tumor control, overall survival, progression-free survival, and quality of life. The adaptive approach allows for daily adjustments based on MRI scans, potentially reducing radiation exposure to healthy brain tissue. The study will assess the impact of this method on neurocognitive function and treatment-related toxicity.
Who should consider this trial
Good fit: Ideal candidates are adults with histopathologically confirmed glioblastoma who are clinically appropriate for long course radiation therapy.
Not a fit: Patients with glioblastoma who have not undergone recent biopsy or surgical resection, or those with significant comorbidities affecting treatment eligibility, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved local control of glioblastoma and enhanced quality of life for patients.
How similar studies have performed: Other studies using adaptive radiation therapy have shown promising results, suggesting potential benefits in local control and reduced toxicity, making this approach a novel advancement in glioblastoma treatment.
Eligibility criteria
Show full 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
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Jay Detsky, MD
- Email: jay.detsky@sunnybrook.ca
- Phone: 416-480-6100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.