Miami "RADAR" Trial

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06077071
Status
Not Yet Recruiting

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Conditions

  • Metastatic Epidural Spinal Cord Compression
  • Spinal Cord Compression

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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).

Key Dates

First listed
Oct 11, 2023
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Sep 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Stereotactic Radiosurgery (SRS) Group
    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.

Primary Outcome Measure

Rate of Safe Avoidance of Surgery [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Benjamin Spieler, MD
[email protected]
305-243-4229
Benjamin Spieler, MD (PRINCIPAL_INVESTIGATOR)
Morgan Freret, MD (PRINCIPAL_INVESTIGATOR)
Gregory Basil, MD (PRINCIPAL_INVESTIGATOR)

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By research site
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