An observational study in Thoracic Neoplasms and Lumbar Neoplasm, sponsored by UNC Lineberger Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Observational
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).
109 studies on the registry are indexed under Thoracic Neoplasms; 32 are open to participants now.
This study's planned enrollment of 70 is below the median of 140 across 25 observational studies indexed under Thoracic Neoplasms.
Browse Thoracic Neoplasms studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient with metastatic thoracic and lumbar spine tumors treated at UNC Chapel Hill
Exclusion Criteria:
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.
Also known as: kyphoplasty
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.
Time frame: Baseline and at 3 months (1 months after completion of radiotherapy)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 1 month
Plan to share: Yes — 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.
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