NCT07479199 Local Radiofrequency Ablation Plus External Beam Radiation for the Treatment of Painful Thoracic and Lumbar Spine Tumors
| NCT ID | NCT07479199 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Thoracic Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-03-16 |
| Primary Completion | 2031-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2026-03-16 with a primary completion date of 2031-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility 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.
Contact & Investigator
Nicole A Keefe
PRINCIPAL INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT07479199 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thoracic Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07479199 currently recruiting?
Yes, NCT07479199 is actively recruiting participants. Contact the research team at markeela_lipscomb@med.unc.edu for enrollment information.
Where is the NCT07479199 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT07479199 clinical trial?
NCT07479199 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is Nicole A Keefe at UNC Lineberger Comprehensive Cancer Center. The trial plans to enroll 70 participants.