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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunnybrook Health Sciences Centre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Radiation Therapy

    Radiation

    Adaptive radiation therapy with GK boost

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Treatment ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative incidence of late local complication (LLC)

Time frame
From end of protocol treatment to development of local failure or symptomatic ISRS Grade => 2 radionecrosis (assessed up to 24 months)

Secondary outcomes

1

Overall Survival

Time frame
Completion of protocol treatment to date of death (assessed up to 24 months)
2

Distant Brain Progression-Free Survival

Time frame
Date of protocol treatment to either appearance of additional metastatic disease within the brain, or death (assessed up to 24 months)
3

Cumulative Incidence of Local Failure

Time frame
Date of completion of protocol treatment to local failure (assessed up to 24 months)
4

Cumulative Incidence of Radiation Necrosis

Time frame
Date of protocol treatment to development of symptomatic radiation necrosis (assessed up to 24 months)

Other outcomes

Sponsors and contacts

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