Status:
RECRUITING
Risk Adapted Spinal Cord/Cauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Brainlab AG
Conditions:
Spinal Cord
Metastatic Epidural
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Greater than or equal to 18 years old
- Radiographically documented spinal metastasis on spine MRI within 4 weeks of registration
- Proximity of spinal metastasis to spinal cord or cauda equina which precludes achieving a GTV Dmin of at least 14 Gy per the PI
- All participants must be able to receive single fraction SSRS at the site of interest with 0.01 cc of the spinal cord receiving 14-16 Gy and/or 0.01 cc of the cauda equina receiving 18-20 Gy. The goal of treatment is to select the minimal dose to the organ at risk which will achieve a GTV Dmin of 14 Gy at the treating physician's discretion.
- Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session
- All participants must be able to receive a single fraction spine radiosurgery at the designated site of interest to at least a dose of 18 Gy
- All participants must have a vertebral level site of interest from C1 to S2
- Signed informed consent
- Diagnosis of cancer excluding ultra-radiosensitive histologies (see 4.2)
- Motor strength ≥ 4 out of 5 in extremity or extremities affected by the level of cord compression
- ECOG ≤ 2
Exclusion
- Participants with ultra-radiosensitive histologies (lymphoma, multiple myeloma/plasmacytoma)
- Prior history of radiation at the spinal site of interest
- Inability to lie supine comfortably for ≥ 60 minutes
- Progressive neurological deficits due to compression
- Inability of obtain an MRI
- Inability or refusal to undergo an MR simulation
- No eligible for single fraction SSRS for any reason
- Participants who are pregnant
Key Trial Info
Start Date :
November 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06204315
Start Date
November 11 2024
End Date
December 31 2029
Last Update
October 24 2025
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030