About this trial
standard paradigm for management of patients who present with concern for recurrence of brain metastases following initial stereotactic radiosurgery (SRS).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability to understand and the willingness to sign a written informed consent document.
Willingness to comply with all study procedures and availability for the duration of the study.
Age ≥18 years. Because no dosing or adverse event data are currently available on the use of SRS2, children are excluded from this study.
Karnofsky performance status ≥ 60.
Disqualifiers
Patients with brain metastases from hematologic malignancies due to significant differences in radiosensitivity and treatment paradigms.
Patients with psychiatric illness/social situations that would limit compliance with study requirements.
Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Trial design
Single group
Treatments tested in this trial
Surgery
Procedure/SurgeryParticipants will initially undergo craniotomy and surgical resection of lesions or LITT
LITT
Procedure/SurgeryParticipants will undergo 4-core stereotactic biopsy and LITT by experienced neurosurgeons with specific expertise.
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
Click on the lead sponsor to view all of their trials.