Adaptive radiotherapy for elderly patients with high-grade glioma

UNITy-BasED MR-Linac Adaptive Simultaneous Integrated Hypofractionated Boost Trial for High Grade Glioma in the Elderly

This study is testing a new way of giving radiation therapy to older patients with high-grade brain tumors to see if it helps them live longer and better compared to standard treatment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Sunnybrook Health Sciences Centre (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT05565521 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of an adaptive radiotherapy approach using MR-Linac technology for elderly patients diagnosed with glioblastoma or IDH-mutant grade 4 astrocytoma. The study aims to deliver a higher radiation dose over a shorter period while adapting treatment plans based on daily MRI scans to account for tumor changes and anatomical variations. By comparing this method to the standard care, the trial seeks to determine if improved radiation delivery can enhance survival outcomes for this patient population.

Who should consider this trial

Good fit: Ideal candidates are patients aged 65 and older with histopathologically confirmed glioblastoma or IDH-mutant grade 4 astrocytoma.

Not a fit: Patients with a life expectancy of less than 12 weeks or those unable to tolerate the required treatment regimen may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved survival rates for elderly patients with high-grade glioma.

How similar studies have performed: Previous studies have shown promising results with increased radiation doses in similar patient populations, suggesting potential for success with this novel adaptive approach.

Eligibility criteria

Inclusion Criteria:

* Patient age ≥ 65 years
* Histopathologically confirmed, based on biopsy or surgical resection, glioblastoma or WHO grade 4 astrocytoma, IDH-mutant
* Biopsy or surgical resection performed ≤ 6 weeks prior to study entry
* Deemed suitable by the treating physicians for 15 daily fractions of radiation, delivered daily over 3 weeks, with concurrent temozolomide chemotherapy
* Expected survival ≥ 12 weeks
* ECOG performance status of 0, 1 or 2
* Able (sufficiently fluent in English) and willing to complete QOL 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 as per standard MRI screening policy
* Contraindication to Gadolinium-based contrast media
* Inability to lie flat in a supine position for at least 90 minutes
* Inability to tolerate immobilization in a head thermoplastic mask
* Patients \> 140 kg and/or a circumference \> 60 cm
* Prior dose-limiting cranial irradiation
* T1w post-gadolinium enhancing disease involving the brainstem
* Leptomeningeal dissemination of disease
* Patients with any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol

Where this trial is running

Toronto, Ontario

• Odette Cancer Centre, Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Study coordinator: Chia-Lin (Eric) Tseng, MD

Conditions: Glioblastoma Multiforme, Adult, Glioblastoma, IDH-mutant