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New treatment option for Spine Metastases
Official title Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for the Treatment of Vertebral Metastases
ClinicalTrials.gov ID: NCT04218617
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Karnofsky Performance Status (KPS) ≥ 70
- RPA class 1 (KPS \>70 AND controlled systemic disease) or RPA Class 2 (KPS \>70, uncontrolled systemic disease OR KPS ≤70, age ≥54, no visceral...
- Vertebral metastases from C3 to L5 based on bone scan, CT, PET, or MRI.
- Vertebral metastases must be (1) solitary, (2) at two contiguous levels, or (3) a maximum of three separate sites, with a maximum of two contiguous...
- Radioresistant metastases are permitted (including sarcomas, melanomas, and renal cell carcinomas).
You likely can't join if
- 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.
See the full eligibility criteria
- Karnofsky Performance Status (KPS) ≥ 70
- RPA class 1 (KPS \>70 AND controlled systemic disease) or RPA Class 2 (KPS \>70, uncontrolled systemic disease OR KPS ≤70, age ≥54, no visceral metastases)44 (see Appendix II)
- Vertebral metastases from C3 to L5 based on bone scan, CT, PET, or MRI.
- Vertebral metastases must be (1) solitary, (2) at two contiguous levels, or (3) a maximum of three separate sites, with a maximum of two contiguous levels.
- Radioresistant metastases are permitted (including sarcomas, melanomas, and renal cell carcinomas).
- Patients with epidural disease are permitted so long as there is no cord compression.
- Paraspinal extension is permitted, so long as the paraspinal component is ≤5 cm
- Multiple small metastatic lesions (\<20% vertebral body involvement) of no clinical correlate are permitted, and not included in the irradiated segments as per RTOG 0631
- History and physical within four weeks of registration.
- Negative pregnancy test within four weeks of registration for women of childbearing potential.
- Diagnostic spine MRI with and without contrast within four weeks of registration
- Neurological exam within four weeks of registration to rule out rapid neurological decline. Mild to moderate neurological deficits are acceptable, as long as distance between lesion and spinal cord is ≥3 mm
- Patients may have prior EBRT at the index site.
- Informed consent of the participant.
- 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.
- Patients with emergent spinal cord compression.
- Patients with mechanical instability of the spine.
- Patients with active connective tissue disease.
- Patients who previously underwent sSRS to the vertebrae of interest.
- Patients with diffuse or multilevel metastatic spinal disease with \>20% involvement of vertebral bodies, defined as involvement of \>5 vertebral levels.
- Inability to participate in study activities due to physical or mental limitations.
- Inability or unwillingness to return for all required follow-up visits and imaging.
- Inability to deliver sSRS, either 18 Gy in one fraction, or 24 Gy in two fractions.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.