An interventional study of Stereotactic Radiosurgery (SRS) in Metastatic Epidural Spinal Cord Compression and Spinal Cord Compression, sponsored by University of Miami. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
The purpose of this study is to see if treating cancer with radiation therapy administered by the Varian Ethos system can control patient's tumor and eliminate the need for surgery used to treat nerves in the spine flattened by pressure (compressed).
52 studies on the registry are indexed under Spinal Cord Compression; 19 are open to participants now.
This study's planned enrollment of 10 is below the median of 43 across 35 interventional studies indexed under Spinal Cord Compression.
Browse Spinal Cord Compression studies →University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will undergo fractionated stereotactic radiosurgery (SRS) on the Varian Ethos platform, with day of treatment magnetic resonance imaging (MRI) simulation fused to HyperSight commuted tomography (CT) imaging. Participants will receive five (5) doses (fractions) of radiation therapy over four (4) weeks. Total participation duration is approximately 2 years.
Radiation: Stereotactic Radiosurgery (SRS)
The treatment regimen consists of 8.0 Gy of radiation therapy administered on the Varian Ethos platform, delivered over five (5) fractions prescribed to the planning target volume (PTV) over 4 weeks, with one (1) to two (2) fractions delivered weekly and at least 48 hours between any two fractions.
Rate of Safe Avoidance of Surgery
The rate of safe avoidance of surgery will be reported as the number of participants experiencing both (1) the absence of local progression at the treated spine level (s), and (2) the absence of surgery at the treated spine level(s) due to disease progression and/or structural instability, after completion of protocol therapy.
Time frame: 6 months
Investigator Confidence in Ethos Virtual Magnetic Resonance (MR) Workflow
Investigators participating in the protocol, including physicians, physicists, dosimetrists and therapists, will complete an in-house longitudinal usability survey before each treatment session to evaluate the effectiveness, efficiency, satisfaction and learnability of the Ethos virtual magnetic resonance (MR) workflow. An Ethos emulator that allows investigators to evaluate contour and plan generation in advance of treatment delivery will assist in streamlining this process.
Time frame: Day 1 of Treatment, Up to 4 weeks
Rate of Radiation Myelopathy (RM)
The rate of radiation myelopathy will be reported as the number of participants with change in scores on the Modified McCormick Scale from a baseline score of A, B, or C to post-treatment score of D or E as recorded at interval follow-ups (weekly during radiation therapy, two, three and six months after protocol enrollment). Scores of D or E indicate a higher degree of neurologic deterioration. The treating physician will determine if scores are probably or definitely related to protocol therapy and not to surgery or local progression of tumor. Scores on the Modified McCormick Scale are as follows: A = No abnormality; B = Focal minor symptom (e.g. pain); C = Functional paresis; D = Nonfunctional paresis; and E = Paralysis or incontinence.
Time frame: Baseline, Up to 8 months
Rate of Vertebral Compression Fracture (VCF)
The rate of vertebral compression fracture (VCF) is determined by the number of participants who develop VCF possibly, probably, or definitely related to the protocol therapy, as opposed to tumor progression. This is assessed and determined by the treating physician by reviewing the initial MRI done prior to starting protocol therapy compared to MRI scans done at follow up visits after receiving protocol therapy.
Time frame: Up to 2 years
Number of Participants Experiencing Grade 2 or Higher Treatment-Related Adverse Events
The number of participants experiencing grade 2 or higher adverse events, probably or definitely related to protocol therapy will be reported. Adverse events will be assessed by the treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
Time frame: Up to 12 months
Quality of Life Among Study As Measured by Scores on PROMIS Short Form Version 1.0
Quality of life among participants will be measured by scores on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form version 1.0. PROMIS Short Form version 1.0 consists of targeted, fixed-length questionnaires derived from National Institute of Health (NIH) item banks to measure physical, mental, and social health domains. Scores use a T-score metric standardized to a mean of 50 and standard deviation of 10 relative to the general population. PROMIS Short Form version 1.0 scores will be measured at baseline, 1 month, 3 months and 6 months after protocol enrollment.
Time frame: Baseline, Up to 6 months
Rate of Ambulation Preservation
Ambulation status among participants will be evaluated on a four-level scale where a score of 0 = normal, 1 = walking with one cane, 2 = walking with a walker frame, and 3 = walking not possible. Scores of 3 at interval follow-up indicate loss of independent ambulation. The rate of ambulation preservation is the number of patients with preservation divided by the total number of patients on study. Preservation is determined by comparing baseline ambulatory score to interval follow up score.
Time frame: Up to 2 years
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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