RecruitingNot Applicable

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

United States70 participantsStarted 2026-03-16

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in pain intensity

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

Trial details

NCT IDNCT07479199

SponsorUNC Lineberger Comprehensive Cancer Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2031-03-01

Contact for this trial

Markeela Lipscomb

919-984-0000 markeela_lipscomb@med.unc.edu