Miami "RADAR" Trial

NCT06077071 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 20221377
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Metastatic Epidural Spinal Cord Compression; Spinal Cord Compression

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (6)

• Investigator Confidence in Ethos Virtual Magnetic Resonance (MR) Workflow

  Day 1 of Treatment, Up to 4 weeks

• Rate of Radiation Myelopathy (RM)

  Baseline, Up to 8 months

• Rate of Vertebral Compression Fracture (VCF)

  Up to 2 years

• Number of Participants Experiencing Grade 2 or Higher Treatment-Related Adverse Events

  Up to 12 months

• Quality of Life Among Study As Measured by Scores on PROMIS Short Form Version 1.0

  Baseline, Up to 6 months

Study Arms (1)

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.

Radiation: Stereotactic Radiosurgery (SRS)

Interventions

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.

Stereotactic Radiosurgery (SRS) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• a. An exception to this criterion may be made if the patient is evaluated by a spinal surgeon and the surgeon defers surgery.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Miami: lead
• Varian Medical Systems: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Spinal Cord Compression

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Benjamin Spieler, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Spieler, MD

CONTACT

305-243-4229; bxs737@med.miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 11, 2023
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)