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Recruiting NCT07479199

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

Conditions: Thoracic Neoplasms Lumbar Neoplasm

Sponsor: UNC Lineberger Comprehensive Cancer Center

trial.available_in: БГ
Overview
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
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.
Interventions
kyphoplasty with Osteocool
PROCEDURE
Locations 1
United States (1)
UNC Hospitals
Chapel Hill , North Carolina
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
16.03.2026
Completion date
01.03.2031
Registry ID
NCT07479199
Source
clinicaltrials.gov
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