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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT07162246
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Sunnybrook Health Sciences Centre
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain (Nervous System) Cancers, Brain Metastasases, SRS
Arms & Interventions

Arms

Experimental: Treatment Arm

Interventions

Radiation: - Radiation Therapy

Adaptive radiation therapy with GK boost

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sunnybrook Health Sciences Centre, Toronto 6167865, Ontario 6093943, Canada

Status

Recruiting

Address

Sunnybrook Health Sciences Centre

Toronto 6167865, Ontario 6093943, M4N3M5

Site Contact

Aimee Theriault

[email protected]

4164806100 #x67364

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