Risk Adapted Spinal Cord/Cauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery

Spinal Cord Clinical Trial

Official title: Risk Adapted Spinal Cord/Cauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery

Status Not yet recruiting

Clinical Trial Summary

To learn about the safety of a procedure called cord dose escalated spine stereotactic radiosurgery (CDE-SSRS) in patients with MESCC.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Spinal Cord
• Spinal Cord Compression

• NCT number: NCT06204315
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Contact: Amol Ghia, MD
• Phone: (832) 628-7357
• Email: ajghia@mdanderson.org
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 30, 2024
• Completion date: December 31, 2029