Combining Gamma Knife and Linac radiosurgery for large brain tumors and metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, single-center interventional protocol at Sunnybrook uses a planned combination of Gamma Knife (GK) and linear accelerator (Linac) stereotactic radiosurgery to treat large intracranial lesions. Eligible adults with up to two large lesions among as many as ten total brain metastases receive focused treatments delivered by both machines, with fractionation and dosing chosen based on lesion size and location. Outcomes include tumor control, radiation necrosis rates, and other treatment-related adverse events monitored by MRI and clinical follow-up. The trial aims to characterize the safety and preliminary effectiveness of the combined approach compared with historical outcomes for fractionated Linac SRS.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Presence of up to two large intracranial lesions
* Up to 10 (previously untreated, or progressing after previous treatment) brain metastases at the time of enrollment on the diagnostic MRI (which includes the ILLs) to be treated with SRS/HSRS
* Age =\> 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Expected survival \>3 months
* Patients that are deemed suitable for both GK and Linac based treatment
* Patients that are able to hold systemic cancer chemotherapy/immunotherapy at least 2 days prior and following an SRS fraction

Exclusion Criteria:

* Prior SRS to the ILLs
* Prior WBRT, or plan for concurrent WBRT with the protocol treatment
* Presence or history of any leptomeningeal/pachymeningeal disease
* Metastatic disease within the ventricles of the brain or corpus callosum
* Small cell, hematopoietic or germ cell primaries
* Patient with absolutely contraindications for MRI
* Severe symptoms that preclude MRI or treatment using standard procedures for Linac or GK
* Pregnant or lactating patient
* Inability or unwillingness to undergo informed consent or post-treatment follow-up

Where it's running

• Sunnybrook Health Sciences Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Hanbo Chan, MD
• Email: hanbo.chen@sunnybrook.ca
• Phone: 4164804974

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.