NCT06204315 Risk Adapted Spinal Cord/Cauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery
| NCT ID | NCT06204315 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Spinal Cord |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-11-11 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2024-11-11 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To learn about the safety of a procedure called cord dose escalated spine stereotactic radiosurgery (CDE-SSRS) in patients with MESCC.
Eligibility 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
Contact & Investigator
Amol Ghia, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT06204315 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Cord. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06204315 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06204315 currently recruiting?
Yes, NCT06204315 is actively recruiting participants. Contact the research team at ajghia@mdanderson.org for enrollment information.
Where is the NCT06204315 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06204315 clinical trial?
NCT06204315 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Amol Ghia, MD at M.D. Anderson Cancer Center. The trial plans to enroll 60 participants.