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RecruitingObservational

Local Radiofrequency Ablation Plus External Beam Radiation for the Treatment of Painful Thoracic and Lumbar Spine Tumors -SPARC

NCT ID: NCT07479199Sponsor: UNC Lineberger Comprehensive Cancer CenterLast updated: 2026-04-23

Summary

This study looks at how well a combination of treatments helps reduce pain in people with tumors in the middle and lower back (thoracic and lumbar spine). All participants receive the same treatment, which includes a procedure to stabilize the spine (kyphoplasty), radiofrequency ablation will be with the Osteocool system and radiation therapy. The goal is to see how effective this combined approach is at relieving pain. The purpose of this study is to find out whether combining these three treatments provides better pain relief for patients with thoracic and lumbar spine tumors. This study is for adults who have cancer that has spread to the thoracic or lumbar spine and who report moderate to severe back pain (a pain score of 5 or higher on a 0-10 pain scale).

Arms & interventions

  • Procedurekyphoplasty with Osteocool

    Participants will receive kyphoplasty with Osteocool prior to their Standard of Care External Beam Radiotherapy.

Outcome measures

Primary

  • Change in pain intensity

    Change in pain intensity will be measured using visual analog scale (VAS) assessments, from baseline (pre-therapy) to 1 month post completion of radiotherapy.

    Time frame: Baseline and at 3 months (1 months after completion of radiotherapy)

Secondary

  • Presence of thoracic and lumbar spine tumors

    Time frame: at 3- and 6-months following procedure

  • Long term new or worsened vertebral body compression fracture

    Time frame: at 6 months following procedure

  • Retreatment of thoracic and lumbar spine tumor

    Time frame: at 6 months following procedure

  • Quality of life per Patient-Reported Outcomes version of the Common Terminology Criteria

    Time frame: Baseline and at 6 months following procedure

  • Pain level

    Time frame: Baseline and at 6 months following procedure

  • Readmission rate

    Time frame: Up to 6 months following procedure

  • Narcotic pain medication

    Time frame: Up to 6 months following procedure

  • Grade 2 or higher Adverse Events

    Time frame: Up to 1 month

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (1)

UNC Hospitals

Chapel Hill, North Carolina, 27599

Recruiting
Markeela Lipscomb · Contact
919-843-9463markeela_lipscomb@med.unc
Desma Jones · Contact
919-984-0000ddesma_jones@med.unc.edu
Nicole A Keefe, MD · Principal Investigator