New radiation technique may spare spine patients from surgery
NCT ID NCT06077071
First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 4 times
Summary
This study tests a precise, MRI-guided radiation treatment for people with cancer that has spread to the spine and is pressing on the spinal cord. The goal is to shrink the tumor enough to avoid surgery. About 24 adults with solid tumors like breast, prostate, or lung cancer will receive this treatment and be followed for one year to see if surgery can be avoided.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male and female participants ages ≥ 18. 2. Solid tumors causing Metastatic epidural spinal cord compression (MESCC) for which surgery is an option as first-line treatment. 3. Tumor histologies eligible for treatment include breast, prostate, sarcoma, melanoma, gastrointestinal types, NSCLC and renal cancers. Other solid malignancy types are also allowed at discretion of investigator if not specifically excluded by criteria. 4. MRI of involved spine within 4 weeks prior to registration to determine extent of spine involvement. 5. Bilsky scale ≥ 1c MESCC with tumor ≤ 1 mm from the spinal cord or cauda equina nerve roots anywhere from C1 to terminus of cauda equina on screening MRI. 6. Protocol defined MESCC must involve no more than 3 contiguous vertebral levels. MESCC can involve multiple non-contiguous spinal canal regions within those 3 contiguous vertebral levels. 7. Karnofsky performance score ≥60 8. Survival prognosis ≥3 months 9. Medical status allowing surgery. 10. Neurologic exam within 1 week prior to registration and again within 1 week of first treatment to rule out severe neurologic deficits caused by disease at site of cord compression. 11. Patients with mild to moderate cord neurologic signs are eligible if they are improved or stabilized by steroid. These neurologic signs include radiculopathy, dermatomal sensory change, and muscle strength of involved extremity 4/5 (lower extremity for ambulation or upper extremity for raising arms and/or arm function). 12. All patients must be ambulatory. 13. Numerical Rating Pain Scale within 1 week prior to registration (back pain permitted for enrollment). 14. Spine instability neoplastic score \< 14. a. An exception to this criterion may be made if the patient is evaluated by a spinal surgeon and the surgeon defers surgery. 15. Willing and able to undergo daily MRI during treatment. 16. Willingness and able to use an acceptable method of contraception during the study and for at least 6 months after stopping the therapy. 17. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. 18. History and physical within 2 weeks prior to registration. 19. Patients must provide study specific informed consent prior to study entry. Exclusion Criteria: 1. Unknown primary histology. 2. Patients with rapid neurologic decline. 3. Bony retropulsion causing neurologic abnormality. 4. Non-ambulatory patients. 5. Prior radiation to the involved site. 6. Inability to have an MRI. 7. Pre-existing or concomitant neurological problems not related directly to MESCC (e. g., neurologic deficits due to brain metastases). 8. Very radiosensitive tumor histology (e.g., myeloma, seminoma, germ cell tumors, leukemia, and lymphoma). 9. Patients with impaired decision-making capacity.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Miami
Miami, Florida, 33136, United States
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Other studies related to the condition(s) this trial covers.
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