NCT04802603 Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column
| NCT ID | NCT04802603 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baptist Health South Florida |
| Condition | Spine Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-03-14 |
| Primary Completion | 2029-09-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2021-03-14 with a primary completion date of 2029-09-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Rupesh Kotecha, MD
PRINCIPAL INVESTIGATOR
Miami Cancer Institute (MCI) at Baptist Health, Inc.
Frequently Asked Questions
Who can join the NCT04802603 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spine Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04802603 currently recruiting?
Yes, NCT04802603 is actively recruiting participants. Contact the research team at RupeshK@baptisthealth.net for enrollment information.
Where is the NCT04802603 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT04802603 clinical trial?
NCT04802603 is sponsored by Baptist Health South Florida. The principal investigator is Rupesh Kotecha, MD at Miami Cancer Institute (MCI) at Baptist Health, Inc.. The trial plans to enroll 60 participants.