Metastatic Epidural Spinal Cord CompressionRADARNCT06077071
Miami "RADAR" Trial
A study testing Stereotactic Radiosurgery (SRS) in people with Metastatic Epidural Spinal Cord Compression and Spinal Cord Compression, run by University of Miami at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Epidural Spinal Cord Compression, Spinal Cord Compression
- What is being tested?
- Stereotactic Radiosurgery (SRS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants ages ≥ 18.
- Solid tumors causing Metastatic epidural spinal cord compression (MESCC) for which surgery is an option as first-line treatment.
- 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.
- MRI of involved spine within 4 weeks prior to registration to determine extent of spine involvement.
- 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.
- 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.
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- Karnofsky performance score ≥60
- Survival prognosis ≥3 months
- Medical status allowing surgery.
- 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.
- 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).
- All patients must be ambulatory.
- Numerical Rating Pain Scale within 1 week prior to registration (back pain permitted for enrollment).
- Spine instability neoplastic score < 14.
- An exception to this criterion may be made if the patient is evaluated by a spinal surgeon and the surgeon defers surgery.
- Willing and able to undergo daily MRI during treatment.
- Willingness and able to use an acceptable method of contraception during the study and for at least 6 months after stopping the therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- History and physical within 2 weeks prior to registration.
- Patients must provide study specific informed consent prior to study entry.
Who cannot join
- Unknown primary histology.
- Patients with rapid neurologic decline.
- Bony retropulsion causing neurologic abnormality.
- Non-ambulatory patients.
- Prior radiation to the involved site.
- Inability to have an MRI.
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- Pre-existing or concomitant neurological problems not related directly to MESCC (e. g., neurologic deficits due to brain metastases).
- Very radiosensitive tumor histology (e.g., myeloma, seminoma, germ cell tumors, leukemia, and lymphoma).
- Patients with impaired decision-making capacity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Miami
Miami, Florida, 33136
Benjamin Spieler, MD, 305-243-4229, bxs737@med.miami.edu
Benjamin Spieler, MD
About this study
Official title: The Miami "RADAR" Trial - RAdiosurgical Debulking of Asymptomatic/Radiographic Spinal Cord Compression
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).
- Being tested
- Stereotactic Radiosurgery (SRS)
- Medical subject headings
- Spinal Cord Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Radiosurgery (SRS)Radiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Radiosurgery (SRS) Group | Experimental | 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. Receives: Radiation: Stereotactic Radiosurgery (SRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Epidural Spinal Cord CompressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Principal investigator, Benjamin Spieler, University of Miami
- Investigators
- Benjamin Spieler, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077071
- Sponsor's protocol ID
- 20221377
- Acronym
- RADAR
- Status last verified
- Jul 2026
- First submitted
- 4 Oct 2023
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Miami "RADAR" Trial - RAdiosurgical Debulking of Asymptomatic/Radiographic Spinal Cord Compression
- ClinicalTrials.gov ID
- NCT06077071
- Acronym / sponsor ID
- RADAR / 20221377
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Radiosurgery (SRS) Group | Experimental | Radiation: Stereotactic Radiosurgery (SRS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Male and female participants ages ≥ 18.
- Solid tumors causing Metastatic epidural spinal cord compression (MESCC) for which surgery is an option as first-line treatment.
- 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.
- MRI of involved spine within 4 weeks prior to registration to determine extent of spine involvement.
- 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.
Key exclusion criteria (9 listed)
- Unknown primary histology.
- Patients with rapid neurologic decline.
- Bony retropulsion causing neurologic abnormality.
- Non-ambulatory patients.
- Prior radiation to the involved site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | Stereotactic Radiosurgery (SRS) Group |
Primary outcome
Rate of Safe Avoidance of Surgery
Time frame: 6 months
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.
6 secondary outcomes
Investigator Confidence in Ethos Virtual Magnetic Resonance (MR) Workflow
Time frame: Day 1 of Treatment, Up to 4 weeks
Rate of Radiation Myelopathy (RM)
Time frame: Baseline, Up to 8 months
Rate of Vertebral Compression Fracture (VCF)
Time frame: Up to 2 years
Number of Participants Experiencing Grade 2 or Higher Treatment-Related Adverse Events
Time frame: Up to 12 months
Quality of Life Among Study As Measured by Scores on PROMIS Short Form Version 1.0
Time frame: Baseline, Up to 6 months
Rate of Ambulation Preservation
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Spieler, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Radiosurgery (SRS) in people with Metastatic Epidural Spinal Cord Compression and Spinal Cord Compression, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Spieler, MD (305-243-4229, bxs737@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Safe Avoidance of Surgery (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.