Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07162246

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

Led by Sunnybrook Health Sciences Centre · Updated on 2025-09-09

60

Participants Needed

1

Research Sites

254 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presence of up to two large intracranial lesions
  • Up to 10 brain metastases at enrollment, untreated or progressing after previous treatment
  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Expected survival longer than 3 months
  • Suitable for both Gamma Knife and Linac based treatments
  • Able to withhold systemic chemotherapy or immunotherapy at least 2 days before and after each radiosurgery fraction
Not Eligible

You will not qualify if you...

  • Prior stereotactic radiosurgery to the large intracranial lesions
  • Prior whole brain radiation therapy or planned concurrent whole brain radiation therapy
  • Presence or history of leptomeningeal or pachymeningeal disease
  • Metastatic disease within brain ventricles or corpus callosum
  • Small cell, hematopoietic, or germ cell primary cancers
  • Absolute contraindications to MRI
  • Severe symptoms preventing MRI or standard Linac/Gamma Knife treatment
  • Pregnancy or lactation
  • Inability or unwillingness to provide informed consent or complete post-treatment follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N3M5

Actively Recruiting

Loading map...

Research Team

H

Hanbo Chan, MD

CONTACT

A

Aimee Theriault

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here