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New treatment option for Spine Metastases
Official title Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column
ClinicalTrials.gov ID: NCT04802603
What this study is testing
- What it's testing
- This study is being done to determine the feasibility and tolerability of a novel regimen of spine stereotactic radiosurgery (SSRS). SSRS delivers high doses of radiation to tumors of the spine using precision techniques.
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
- Zubrod Performance Status 0-2
- Localized spine metastasis from a solid tumor from the C1 to L5 levels (a solitary spine metastasis, two separate spine levels, or up to 3 separate...
- Patients with epidural extension are eligible as long as there is a ≥ 2 mm gap between the spinal cord and the edge of the epidural lesion
- Paraspinal disease extension is allowed as long as it measures ≤ 5 cm in the greatest dimension and that it is contiguous with the spine metastasis
- For patients enrolled in cohort 2, the minimum time to re-irradiation should be 6 months
You likely can't join if
- Radiosensitive histologies (myeloma, lymphoma, germ cell tumors, small cell lung cancer)
- Non-ambulatory patients
- \>50% loss of vertebral body height or spinal instability to due pathologic compression fracture
- Frank spinal cord compression, spinal cord displacement, or epidural extension within 2 mm of the spinal cord
- Rapid neurologic decline
- Patients for whom an MRI of the spine is medically contraindicated
See the full eligibility criteria
- Zubrod Performance Status 0-2
- Localized spine metastasis from a solid tumor from the C1 to L5 levels (a solitary spine metastasis, two separate spine levels, or up to 3 separate sites; each of the separate sites may have a maximal involvement of 2...
- Patients with epidural extension are eligible as long as there is a ≥ 2 mm gap between the spinal cord and the edge of the epidural lesion
- Paraspinal disease extension is allowed as long as it measures ≤ 5 cm in the greatest dimension and that it is contiguous with the spine metastasis
- For patients enrolled in cohort 2, the minimum time to re-irradiation should be 6 months
- Numerical Rating Pain Scale (NRPS) score of ≥ 5 at the index site(s) (as rated when the patient is not taking pain medication)
- Radiosensitive histologies (myeloma, lymphoma, germ cell tumors, small cell lung cancer)
- Non-ambulatory patients
- \>50% loss of vertebral body height or spinal instability to due pathologic compression fracture
- Frank spinal cord compression, spinal cord displacement, or epidural extension within 2 mm of the spinal cord
- Rapid neurologic decline
- Patients for whom an MRI of the spine is medically contraindicated
- Pregnant women
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, 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 Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
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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.