RecruitingPhase 2NCT05565521

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


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

55 participants

Start Date

Dec 13, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The usual standard of care for patients over 65 diagnosed with glioblastoma ("GBM") or Grade 4 astrocytoma, IDH-mutant is a 3-week course of radiotherapy, with concurrent and adjuvant temozolomide (TMZ). This radiation dose and length of treatment are less than what would be given for younger patients, primarily due to unclear survival benefits from randomized trials. However, survival remains dismal, and may be partially due to the reduced radiation dose. Recent studies investigating this have found that increased radiation dose (to the equivalent of what is normally given over 6 weeks in younger patients) over 3 weeks is well-tolerated and has improved survival rates. Additionally, with the advent of novel technology such as the MR-Linac, adaptive radiotherapy with this regimen using reduced radiation margins is possible. Use of the MR-Linac allows for daily MRI scans to be done prior to treatment, so plans can be adapted to tumour dynamics and anatomical deformations. In this trial, we will examine the outcomes of increased radiation dose, combined with reduced-margin adaptive radiotherapy in this patient population.


Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing an adaptive radiation therapy approach using an MRI-guided radiation machine (MR-Linac) for elderly patients with glioblastoma — an aggressive brain tumor. The study tests whether a shorter, more intense radiation course tailored in real-time to the tumor's shape can be safely and effectively delivered alongside standard chemotherapy. **You may be eligible if...** - You are 65 years of age or older - You have been diagnosed with glioblastoma (WHO grade 4) or IDH-mutant grade 4 astrocytoma confirmed by biopsy or surgery within the past 6 weeks - Your doctors believe you can tolerate 15 daily radiation sessions (3 weeks) with chemotherapy - Your performance status is ECOG 0, 1, or 2 - You are expected to survive at least 12 weeks - You can have MRI scans (with contrast) **You may NOT be eligible if...** - You cannot have an MRI (e.g., incompatible metal implants) - You cannot lie flat on your back for at least 90 minutes - You cannot tolerate a head immobilization mask - You weigh over 140 kg or have a very large body circumference (>60 cm) - You have had prior brain radiation - The tumor involves the brainstem or has spread throughout the membranes covering the brain Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONDose escalation + Reduced Margin Adaptive Radiotherapy

Concurrent chemoradiation with temozolomide (TMZ) over 3 weeks (40 Gy in 15 fractions). The gross tumor volume (GTV) plus margin will be boosted simultaneously (SIB) to 52.5 Gy in 15 fractions. Radiation will be delivered on the MR-Linac with a reduced clinical target volume (CTV) margin of minimum 5 mm and a weekly online adaptive approach.


Locations(1)

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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NCT05565521


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