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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
MD Anderson Cancer Center
Houston, Texas, United States
Start Date
November 11, 2024
Primary Completion Date
December 31, 2027
Completion Date
December 31, 2029
Last Updated
January 26, 2026
60
ESTIMATED participants
Stereotactic Radiosurgery
RADIATION
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
NCT06521723
NCT05563103
NCT04894734
Data Source & Attribution
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