The Miami "RADAR" Trial - RAdiosurgical Debulking of Asymptomatic/Radiographic Spinal Cord Compression
University of Miami
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- RadiationStereotactic 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.
Location
- University of MiamiMiami, Florida