Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for the Treatment of Vertebral Metastases (NCT04218617)
🩺 Plain-English Summary (8th-Grade Level)
Spine radiosurgery (SRS) utilizes advanced treatment planning with focused x-rays to deliver one to four high dose treatments to the spine to help relieve pain and/or neurologic symptoms. Spine SRS uses special equipment to position the participant and guide the focused beams toward the area to be treated and away from normal tissue. One of the side effects of spine SRS is the development of vertebral compression fractures, many of which are not painful. The goal of this study is to compare the effects, good and/or bad, of spine SRS given in 1 or 2 treatments. Our main goal is to find out which approach will reduce the chances of developing vertebral compression fractures.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (14 items) and avoid the listed exclusions (20 items).
Location: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center — Cleveland, Ohio
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Lesions at C1-2 or S1-Coccyx.
- Hematologic malignancies including lymphoma and myeloma.
- Multiple primary cancers.
- Primary neoplasms of the spine
- Prior corpectomy, kyphoplasty/vertebroplasty, or instrumentation at the site of planned sSRS.
- Spinal cord compression.
- Paraspinal mass \>5 cm.
- Patients with rapid neurologic decline.
- Bony retropulsion resulting in neurologic deficit.
- Patients with contraindications to MRI.
- Patients allergic to intravenous contrast for MRI or CT.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center — Cleveland, Ohio
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.