RecruitingPhase 2NCT07162246

Combined Gamma Knife/Linac Radiosurgery for Large Brain Tumors / Metastases

Combined Gamma Knife/Linac Hypofractionated Stereotactic Radiosurgery for Large Intracranial VolumEs (GK-LIVE): A Prospective Phase II Single-Arm Trial


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

60 participants

Start Date

Jul 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

When cancer spreads to the brain, doctors often use a precise type of radiation therapy called stereotactic radiosurgery (SRS) to treat these tumors. This treatment can effectively control brain tumors while helping protect healthy brain tissue. However, when brain tumors or the areas where tumors were surgically removed are larger, treatment outcomes in terms of side effects and tumour control can become worse. Specifically, standard SRS on larger areas can have lower tumour control and higher risk of side effects, particularly a condition called radiation necrosis, which can cause swelling and damage in nearby healthy brain tissue. Currently at Sunnybrook, large brain tumors are typically treated with SRS spread over 5 daily treatments using a machine called a linear accelerator. While this approach works well for many patients, it may be possible to improve results by combining two different types of radiation therapy machines - the linear accelerator and another specialized machine called the Gamma Knife. In this study, the investigators want to test a new treatment approach where patients first receive 4 daily treatments using the linear accelerator, followed by a 1-2 week break, and then a final treatment using the Gamma Knife. The break between treatments allows the study doctors to take new scans and precisely target any remaining tumor, which may shrink during the break, thereby potentially reducing the amount of healthy brain tissue exposed to radiation. The Gamma Knife is also particularly good at delivering very precise radiation while sparing nearby healthy tissue. Lastly, there may be unique biological mechanisms between the two technologies that could be taken advantage of, by combining the technologies in the participant's treatment plan, to improve cancer control. The investigators believe this combined approach might help achieve better tumor control while reducing the risk of side effects compared to using just the linear accelerator. This study will help the investigators understand if this new treatment strategy is safe and effective for patients with large brain tumors or surgical cavities, and whether it leads to better outcomes than the current treatment approach.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combined approach to treating large brain tumors or brain metastases using two types of highly focused radiation therapy — Gamma Knife and Linac radiosurgery — which together can target tumors that are too big to treat with one method alone. **You may be eligible if...** - You are 18 or older - You have one or two large brain lesions, plus up to 10 total brain tumors (including those previously treated but now progressing) - You are in reasonably good physical health - Your life expectancy is more than 3 months - You are suitable for both Gamma Knife and Linac-based radiation - You can pause chemotherapy or immunotherapy for at least 2 days before and after each radiation treatment **You may NOT be eligible if...** - You have already had radiosurgery to the same large tumors - You have had whole-brain radiation before or it is planned alongside this treatment - You have cancer spread throughout the lining of the brain (leptomeningeal disease) 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

RADIATIONRadiation Therapy

Adaptive radiation therapy with GK boost


Locations(1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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NCT07162246


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