New approach to treat localized spine metastases with radiation therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: RupeshK@baptisthealth.net
• Phone: 786-596-2000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.