Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5, Canada
Location status: Recruiting
NCT Number: NCT07162246
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Toronto, Ontario, M4N3M5, Canada
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Adaptive radiation therapy with GK boost
Time frame: From end of protocol treatment to development of local failure or symptomatic ISRS Grade => 2 radionecrosis (assessed up to 24 months)
Time frame: Completion of protocol treatment to date of death (assessed up to 24 months)
Time frame: Date of protocol treatment to either appearance of additional metastatic disease within the brain, or death (assessed up to 24 months)
Time frame: Date of completion of protocol treatment to local failure (assessed up to 24 months)
Time frame: Date of protocol treatment to development of symptomatic radiation necrosis (assessed up to 24 months)
Time frame: Throughout study participation and assessed up to 24 months following treatment completion
From changes to baseline, as defined by CTCAE v5.0
Time frame: From enrollment onwards, up until 24 months after protocol treatment completion
Through changes in the NANO scale
Time frame: From enrollment onwards, up until 24 months after protocol treatment completion
Through changes in responses to health-related quality of life surveys completed during study participation
Contact information is provided by the study sponsor or research team.
Sunnybrook Health Sciences Centre
Other
Combined Gamma Knife/Linac Hypofractionated Stereotactic Radiosurgery for Large Intracranial VolumEs (GK-LIVE): A Prospective Phase II Single-Arm Trial
Acronym: GK-LIVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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