Actively Recruiting
Combined Gamma Knife/Linac Hypofractionated Stereotactic Radiosurgery for Large Intracranial VolumEs (GK-LIVE): A Prospective Phase II Single-Arm Trial
Led by Sunnybrook Health Sciences Centre · Updated on 2025-09-09
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment approach for patients with large brain tumors or brain metastases using a combination of two types of precise radiation therapy machines: the linear accelerator and the Gamma Knife. This study aims to see if combining these technologies can improve tumor control and reduce side effects compared to the current standard treatment, which uses only the linear accelerator. The researchers believe that the break between treatments and the unique qualities of each machine may help protect healthy brain tissue better and control the tumor more effectively. The treatment plan involves first giving patients four daily radiation treatments with the linear accelerator. After these treatments, there is a 1-2 week break during which new scans are taken to assess tumor shrinkage and better target any remaining tumor areas. The final treatment is then delivered using the Gamma Knife, which provides very precise radiation to the tumor while sparing healthy tissue. This combined approach is being studied in a prospective, single-arm Phase II trial. Participants will be monitored closely throughout the study and for up to 24 months after treatment. Researchers will assess the safety and effectiveness of the combined therapy by measuring late local complications, tumor control, survival, brain progression, radiation side effects, neurological function, and quality of life. Regular imaging scans and clinical evaluations will be done to track outcomes and side effects. The total study duration includes treatment and long-term follow-up to understand the benefits and risks of this new treatment strategy.
CONDITIONS
Brief Title
Combined Gamma Knife/Linac Radiosurgery for Large Brain Tumors / Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of up to two large intracranial lesions
- Up to 10 brain metastases (new or progressing) at enrollment to be treated with SRS/HSRS
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Expected survival longer than 3 months
- Suitable for both Gamma Knife and linear accelerator treatments
- Able to pause systemic chemotherapy or immunotherapy at least 2 days before and after an SRS treatment
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 for MRI
- Severe symptoms preventing MRI or standard treatment procedures
- Pregnancy or breastfeeding
- Inability or unwillingness to give informed consent or comply with follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to the completion of protocol treatment
Participants receive adaptive radiation therapy combining Gamma Knife and linear accelerator (Linac) treatments for large brain tumors or metastases.
1 to 2 treatment visits
Duration - Up to 24 months after treatment completion
Participants are monitored for treatment-related toxicity, neurological function changes, and quality of life for up to 24 months after completing treatment.
Regular follow-up visits during 24 months
Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Actively Recruiting
Research Team
H
Hanbo Chan, MD
A
Aimee Theriault
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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