Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column (NCT04802603) | Clinical Trial Compass
RecruitingNot Applicable
Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column
United States60 participantsStarted 2021-03-14
Plain-language summary
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.
In standard medical care, conventional SSRS is delivered in only 1 or 2 treatments. When this treatment is delivered in only 1-2 treatments, a high dose is used which can increase the side effects of treatment. This study aims to test an alternative technique of delivering SSRS over 5 treatments. By delivering the radiation therapy over multiple treatments, the dose of radiation is less per treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 contiguous vertebral bodies)
* 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)
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in response to spine Stereotactic Body Radiotherapy (SBRT) for Brief Pain Inventory (BPI)
Timeframe: within 5 days of treatment completion
2
Change in response to spine Stereotactic Body Radiotherapy (SBRT) for FACT-G
Timeframe: within 5 days of treatment completion
3
Change in response to spine Stereotactic Body Radiotherapy (SBRT) for EQ-5D-5L