New approach to treat localized spine metastases with radiation therapy

Dose-Escalated Spine SbRT (DESSRT) for Localized Metastasis to the Spinal Column

This study is testing a new way to use radiation therapy over five sessions to see if it can help people with spine metastases manage pain better and improve their overall function.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Baptist Health South Florida (other)
• Drugs / interventions: radiation
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT04802603 on ClinicalTrials.gov

What this trial studies

This study evaluates a novel regimen of spine stereotactic radiosurgery (SSRS) aimed at treating localized metastases to the spinal column. Unlike conventional SSRS, which typically involves 1-2 high-dose treatments, this approach delivers radiation over 5 sessions, potentially reducing side effects while maintaining effectiveness. The study focuses on patients with specific eligibility criteria, including performance status and pain levels, to assess the feasibility and tolerability of this treatment method. The goal is to improve pain control and neurological function in patients suffering from spine metastases.

Who should consider this trial

Good fit: Ideal candidates include patients with localized spine metastasis from solid tumors and a performance status of 0-2.

Not a fit: Patients with radiosensitive tumors or significant vertebral body height loss may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide patients with better pain management and improved quality of life with fewer side effects.

How similar studies have performed: Other studies have shown promising results with stereotactic radiosurgery for spine metastases, indicating that this approach may be effective.

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

Where this trial is running

Miami, Florida

• Miami Cancer Institute at Baptist Health, Inc — Miami, Florida, United States (RECRUITING)

Study contacts

• Principal investigator: Rupesh Kotecha, MD — Miami Cancer Institute (MCI) at Baptist Health, Inc.
• Study coordinator: Rupesh Kotecha, MD

Conditions: Spine Metastases, Metastasis Spine, Localized Metastasis, Spinal Column