Kyphoplasty combined with radiofrequency ablation and radiation for painful thoracic and lumbar spine tumors
Local Radiofrequency Ablation Plus External Beam Radiation for the Treatment of Painful Thoracic and Lumbar Spine Tumors -SPARC
This treatment plan tries to reduce moderate-to-severe back pain in adults whose cancer has spread to the thoracic or lumbar spine by combining kyphoplasty, radiofrequency ablation (OsteoCool), and external beam radiation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT07479199 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with metastatic thoracic or lumbar spine tumors that are lytic or mixed, reporting back pain ≥5 on a 0–10 scale, with life expectancy beyond the procedure and no active infection or contraindicating medications.
Not a fit: Patients with minimal pain (<5), purely blastic lesions, active systemic infection, pregnancy/breastfeeding, inability to hold contraindicated drugs like Avastin or certain anticoagulants, or those already enrolled in another cancer treatment trial may not receive benefit or be eligible.
Why it matters
Potential benefit: If successful, this combined approach could provide faster and greater pain relief plus immediate vertebral stabilization, potentially reducing opioid needs and improving mobility.
How similar studies have performed: Prior reports combining vertebral augmentation, radiofrequency ablation, or radiation have shown palliative pain relief in metastatic spine disease, but randomized, large-scale comparisons remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chapel Hill, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.