Kyphoplasty combined with radiofrequency ablation and radiation for painful thoracic and lumbar spine tumors

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 observational, single-center protocol gives all enrolled adults a combined intervention of kyphoplasty for spinal stabilization, radiofrequency ablation using the OsteoCool system, followed by external beam radiation to thoracic or lumbar metastatic lesions. Participants are adults with lytic or mixed spinal metastases who report a pain score of 5 or higher and have a life expectancy judged sufficient to complete the intervention. Outcomes include pain relief (VAS), spinal stability, functional measures, and adverse events, with follow-up to capture durability of benefit. The study is run at UNC Hospitals with Medtronic collaborating on the device component to gather real-world data on this combined palliative approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
* Subjects is willing and able to comply with study procedures based on the judgement of the investigator.
* Age ≥ 18 years at the time of consent.
* Life expectancy beyond completion of protocol intervention of at least 1 month and deemed appropriate for treatment based on multidisciplinary review and/or investigator discretion.
* Metastatic thoracic or lumbar spine tumor. Tumor should be lytic or mixed lytic/blastic. Note: there does not need to be a fracture.
* Patient reported back pain of ≥ 5 on a VAS scale

Exclusion Criteria:

* Active infection requiring systemic therapy.
* Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
* Is currently taking Avastin or anti-coagulant meds that cannot be held.
* Is currently enrolled in a cancer related clinical trial.

Where it's running

• UNC Hospitals
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Nicole A Keefe — UNC Lineberger Comprehensive Cancer Center
• Study coordinator: Markeela Lipscomb
• Email: markeela_lipscomb@med.unc.edu
• Phone: 919-984-0000

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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.