Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204315
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-01-03
Brief Title:
Risk Adapted Spinal CordCauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Risk Adapted Spinal CordCauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn about the safety of a procedure called cord dose escalated spine stereotactic radiosurgery CDE-SSRS in patients with MESCC
Detailed 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 ie 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-00049 | OTHER | NCI-CTRP Clinical Registry | None |