About this trial
To learn if consolidative stereotactic radiosurgery (cSRS) can help to control central nervous system (CNS) disease in patients who have brain metastases and have a partial response or stable brain metastases after systemic therapy.
To learn if using SRS to treat all brain metastases that do not respond to systemic therapy versus treating only metastases that are getting worse can help to control CNS disease in patients whose disease gets worse after systemic therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years.
Evaluation by a brain metastasis multidisciplinary team (BM-MDT) consisting of a medical oncologist (can be the patient's primary medical oncologist), a radiation oncologist who regularly performs SRS, and a neurosurgeon. This evaluation can take place in clinic or during a multidisciplinary conference.
Life expectancy > 6 months as estimated by BM-MDT.
BM-MDT agreement that the planned systemic therapy regimen may provide intracranial benefit (SD, PR, or CR in the CNS).
Disqualifiers
History of known leptomeningeal involvement (radiographic or cytological).
Small cell lung cancer, lymphoma, or leukemia histology.
Non-small cell lung cancer histology with targetable oncogenic driver mutation with planned initiation of highly CNS active targeted therapy (eg osimertinib, brigatinib, alectinib, or lorlatinib).
Subjects previously treated with WBRT.
Trial design
Single group
Treatments tested in this trial
Systemic Therapy
Other interventionParticipants will receive systemic therapy as a standard of care therapeutic option
Stereotactic Radiosurgery
RadiationParticipants will receive systemic therapy as a standard of care therapeutic option
Treatment groups
Trial outcomes
Primary outcomes
Safety and Adverse Events (AEs).
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Sponsors and contacts
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