Actively Recruiting
Risk Adapted Spinal Cord/Cauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
B
Brainlab AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of a procedure called cord dose escalated spine stereotactic radiosurgery (CDE-SSRS) in patients with metastatic epidural spinal cord compression (MESCC). This study specifically aims to keep the risk of non-functional paresis, defined by the McCormick score as Grade D, at no greater than 1%. Secondary goals include assessing pain control, quality of life, symptom burden, overall survival, toxicity, walking ability, and cost-effectiveness using various patient questionnaires and MRI scans. The treatment involves a non-invasive, precise radiation procedure called stereotactic radiosurgery given in a single session. This radiation targets cancer in the spine while avoiding surrounding healthy tissue. The radiation dose is carefully adjusted based on the tumor's proximity to the spinal cord or cauda equina to achieve effective treatment while protecting critical areas. Participants must have up to three contiguous vertebral levels involved and be able to receive the planned radiation dose safely. Participants will be monitored through regular MRI scans and assessments including pain inventories and quality of life questionnaires. Researchers will track safety and adverse events during the study, which spans an average of one year. The study involves signing informed consent and includes evaluations of motor strength and functional status. The study is sponsored by M.D. Anderson Cancer Center and started in November 2024, continuing through December 2029.
CONDITIONS
Brief Title
Risk Adapted Spinal Cord/Cauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Radiographically confirmed spinal metastasis on MRI within 4 weeks before registration
- Spinal metastasis near spinal cord or cauda equina preventing standard radiation dosing
- Able to receive single fraction stereotactic radiosurgery with specified radiation doses to spinal cord and cauda equina
- Maximum of 3 contiguous vertebral levels involved with metastasis to be treated in one session
- Able to receive at least 18 Gy dose in a single session at the treatment site
- Vertebral level site from C1 to S2
- Signed informed consent
- Diagnosis of cancer excluding ultra-radiosensitive types like lymphoma and multiple myeloma/plasmacytoma
- Motor strength of 4 or greater out of 5 in affected limbs
- ECOG performance status 0 to 2
You will not qualify if you...
- Ultra-radiosensitive cancer types such as lymphoma and multiple myeloma/plasmacytoma
- Previous radiation therapy at the spinal site to be treated
- Unable to lie on back comfortably for 60 minutes or more
- Progressive neurological decline due to spinal cord compression
- Unable to undergo MRI or MR simulation
- Not eligible for single fraction stereotactic radiosurgery for any reason
- Pregnant participants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session
Participants receive a single session of stereotactic radiosurgery, a non-invasive procedure that delivers precise radiation to spine cancer while avoiding surrounding healthy tissue.
1 treatment visit (in-person)
Duration - Up to 1 year
Participants are monitored for safety, pain control, quality of life, symptom burden, overall survival, toxicity, and ambulatory status with assessments including serial MRI scans.
Regular follow-up visits as scheduled over 1 year
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Amol Ghia, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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