To learn about the safety of a procedure called cord dose escalated spine stereotactic radiosurgery (CDE-SSRS) in patients with MESCC.
Primary Objectives The primary protocol objectives are to establish the safety of CDE-SSRS alone in participants with MESCC. Specifically, we aim to maintain an RM risk no greater than 1%. RM will be defined as non-functional paresis per the McCormick score (i.e., Grade D). Secondary Objectives Secondary objectives include pain control as measured by the Brief Pain Inventory, quality of life as measured by the EQ-5D, symptom burden as measured by the MDASI-SP, overall survival, toxicity, ambulatory rate and cost-effectiveness. LC will be defined radiographically with serial MRI scans by the study radiologist per SPINO criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
Given by RTx
MD 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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