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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Thoracic Neoplasms; Lumbar Neoplasm
• Intervention / Treatment: Procedure: kyphoplasty with Osteocool

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Desma Jones; Email: desma_jones@med.unc.edu
• Study Contact Backup: Name: Markeela Lipscomb; Phone Number: 919-984-0000; Email: markeela_lipscomb@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • UNC Hospitals
      • Contact: Markeela Lipscomb; Phone Number: 919-843-9463; Email: markeela_lipscomb@med.unc
      • Contact: Desma Jones; Phone Number: 919-984-0000; Email: ddesma_jones@med.unc.edu
      • Principal Investigator: Nicole A Keefe, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Participants will receive kyphoplasty with Osteocool prior to their Standard of Care External Beam Radiotherapy.; Other Names: kyphoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of thoracic and lumbar spine tumors	Presence of thoracic and lumbar spine residual tumors will be determined by independent radiology report (clinical assessment by a non-investigator) based on any standard of care imaging exam per treating physician's discretion.	at 3- and 6-months following procedure
Long term new or worsened vertebral body compression fracture	Long term new or worsened vertebral body compression fracture of thoracic and lumbar spine tumor subjects treated with kyphoplasty with osteocool ablation plus radiation therapy at the treated level will be determined by independent radiology report (clinical assessment by a non-investigator) based on any standard of care imaging exam per treating physician's discretion.	at 6 months following procedure
Retreatment of thoracic and lumbar spine tumor	Retreatment of thoracic and lumbar spine tumor subjects treated with kyphoplasty with Osteocool ablation plus radiation therapy is defined as treatment at the same vertebral body level with kypho- radiation therapy for disease progression within 6-months of protocol intervention collected via medical record abstraction as compared to historical control.	at 6 months following procedure
Quality of life per Patient-Reported Outcomes version of the Common Terminology Criteria	Quality of life in patients with thoracic and lumbar spine tumors treated with kyphoplasty with Osteocool ablation plus radiation therapy will be evaluated using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurements prior to therapy and at completion of therapy and 6 months after procedure. PRO-CTCAE is a questionnaire that lets patients report symptoms they experience during treatment, such as pain, fatigue, nausea, or skin changes. It measures how often symptoms occur, how severe they are, and how much they interfere with daily activities. Each symptom is scored from 0 to 4 (or 0/1 for absent or present). There is currently no standard method for combining scores into a single overall score.	Baseline and at 6 months following procedure
Pain level	Quality of life in patients with thoracic and lumbar spine tumors treated with kyphoplasty with Osteocool ablation plus radiation will be evaluated by the Brief Pain Inventory prior to therapy and at completion of therapy and 6 months following intervention. The Brief Pain Inventory (BPI), developed by MD Anderson Cancer Center, is a patient-reported questionnaire used to measure pain severity and how pain interferes with daily activities. Patients rate their pain on a scale from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable." They also rate how much pain interferes with activities such as walking, work, mood, and sleep on a 0 to 10 scale, where 0 means "does not interfere" and 10 means "completely interferes." It is widely used in cancer patients to assess pain and its impact on quality of life.	Baseline and at 6 months following procedure
Readmission rate	Quality of life in patients with thoracic and lumbar spine tumors treated with kyphoplasty with Osteocool ablation plus radiation will be evaluated by readmission rate for spine-related pain for the 6 months following the procedure via medical record abstract and self-reported care.	Up to 6 months following procedure
Narcotic pain medication	Narcotic pain medication in patients with thoracic and lumbar spine tumors treated with kyphoplasty with Osteocool ablation plus radiation will be evaluated by self-reported use prior to therapy and for days 1 and 7 post-kyphoplasty and Osteocool ablation and at completion of therapy and 6 months following intervention.	Up to 6 months following procedure
Grade 2 or higher Adverse Events	Safety of kyphoplasty with Osteocool ablation plus radiotherapy will be defined as the frequency and nature of Grade 2+ adverse events post therapy according to The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE ). NCI-CTCAE is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. AE will compared against historical controls receiving gold standard radiation therapy alone.	Up to 1 month

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: Medtronic
• Investigators: Principal Investigator: Nicole A Keefe, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pain; Ablation; Radiofrequency Ablation; Radiofrequency; kyphoplasty; External Beam Radiation; Local Radiofrequency Ablation; Osteocool
• Additional Relevant MeSH Terms: Neurologic Manifestations; Neoplasms by Site; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Neoplasms; Thoracic Neoplasms; Therapeutics; Surgical Procedures, Operative; Orthopedic Procedures; Cementoplasty; Vertebroplasty; Kyphoplasty
• Other Study ID Numbers: LCCC2336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data will be available beginning 1 year after publication. Access will be granted to researchers with a methodologically sound proposal. Requests should be submitted to the corresponding investigator and may require a data use agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No