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

NCT07479199 | Recruiting DMC FDA Device

• 1 other identifier: LCCC2336
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Lumbar Neoplasm; Thoracic Neoplasms

Keywords

pain; Radiofrequency Ablation; Local Radiofrequency Ablation; Radiofrequency; Ablation; External Beam Radiation; kyphoplasty; Osteocool

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (8)

• Presence of thoracic and lumbar spine tumors

  at 3- and 6-months following procedure

• Long term new or worsened vertebral body compression fracture

  at 6 months following procedure

• Retreatment of thoracic and lumbar spine tumor

  at 6 months following procedure

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

  Baseline and at 6 months following procedure

• Pain level

  Baseline and at 6 months following procedure

Study Arms (1)

Metastatic thoracic or lumbar spine tumor

metastatic thoracic or lumbar spine tumor and reported back pain of ≥ 5 on a visual analog scale (VAS) assessments scale.

Procedure: kyphoplasty with Osteocool

Interventions

kyphoplasty with Osteocool PROCEDURE

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

Also known as: kyphoplasty

Metastatic thoracic or lumbar spine tumor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with metastatic thoracic and lumbar spine tumors treated at UNC Chapel Hill

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Medtronic: collaborator

Study Sites (1)

UNC Hospitals

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Thoracic Neoplasms; Neoplasms; Pain

Interventions

Kyphoplasty

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vertebroplasty; Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Nicole A Keefe

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Markeela Lipscomb

CONTACT

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

Desma Jones

CONTACT

desma_jones@med.unc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 18, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)