standard paradigm for management of patients who present with concern for recurrence of brain metastases following initial stereotactic radiosurgery (SRS).
Primary Objective: To determine whether SRS2 following surgery/LITT for patients with recurrent previously irradiated brain metastases improves time to local recurrence compared to close surveillance following surgery/LITT. To summarize time to local recurrence for patients with recurrent previously irradiated brain metastases receiving SRS2 due to being ineligible for surgery/LITT. Secondary Objectives: To test if the effect of SRS2 versus surveillance after LITT or surgery in patients with recurrent previously irradiated brain metastases is associated with the type of surgical intervention. To determine whether SRS2 versus close surveillance following surgery/LITT for recurrent previously irradiated brain metastases improves distant brain metastasis-free survival, intracranial progression-free survival, overall progression-free survival, neurologic death rates, and/or overall survival. To summarize distant brain metastasis-free survival, intracranial progression-free survival, overall progression-free survival, neurologic death rates, and/or overall survival for patients receiving SRS2 alone for recurrent, previously irradiated brain metastases. To summarize patient-reported outcomes including neurocognitive symptoms, functional independence, and quality of life for patients who receive SRS2 for recurrent, previously irradiated brain metastases. To summarize radionecrosis and adverse event rates for patients who receive SRS2 following surgery/LITT for recurrent previously irradiated brain metastases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
155
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
RECRUITINGSafety 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
Time frame: Through study completion; an average of 1 year
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