Safety of a new radiosurgery technique for patients with spinal cord compression from cancer
Risk Adapted Spinal Cord/Cauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery
This study is testing a new type of radiation treatment for cancer patients with spinal cord compression to see if it is safe and helps with pain and quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06204315 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety of a procedure called cord dose escalated spine stereotactic radiosurgery (CDE-SSRS) in patients suffering from metastatic epidural spinal cord compression (MESCC). The primary objective is to ensure that the risk of non-functional paresis remains below 1% while assessing secondary outcomes such as pain control, quality of life, and overall survival. Participants will undergo single fraction radiosurgery targeting spinal metastases, with careful monitoring through MRI scans to evaluate treatment effectiveness and safety. The study will also analyze the cost-effectiveness of this intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with documented spinal metastasis that is close to the spinal cord or cauda equina.
Not a fit: Patients with extensive spinal metastasis beyond three contiguous vertebral levels or those unable to receive the required radiation doses may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective treatment option for patients with spinal cord compression due to cancer.
How similar studies have performed: Other studies have shown promising results with stereotactic radiosurgery for spinal metastases, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Greater than or equal to 18 years old 2. Radiographically documented spinal metastasis on spine MRI within 4 weeks of registration 3. Proximity of spinal metastasis to spinal cord or cauda equina which precludes achieving a GTV Dmin of at least 14 Gy per the PI 4. 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. 5. Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session 6. 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 7. All participants must have a vertebral level site of interest from C1 to S2 8. Signed informed consent 9. Diagnosis of cancer excluding ultra-radiosensitive histologies (see 4.2) 10. Motor strength ≥ 4 out of 5 in extremity or extremities affected by the level of cord compression 11. ECOG ≤ 2 Exclusion Criteria: 1. Participants with ultra-radiosensitive histologies (lymphoma, multiple myeloma/plasmacytoma) 2. Prior history of radiation at the spinal site of interest 3. Inability to lie supine comfortably for ≥ 60 minutes 4. Progressive neurological deficits due to compression 5. Inability of obtain an MRI 6. Inability or refusal to undergo an MR simulation 7. No eligible for single fraction SSRS for any reason 8. Participants who are pregnant
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Amol Ghia, MD — M.D. Anderson Cancer Center
- Study coordinator: Amol Ghia, MD
- Email: ajghia@mdanderson.org
- Phone: (832) 628-7357
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.