Local Radiofrequency Ablation Plus External Beam Radiation for the Treatment of Painful 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.

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.

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.

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.

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.

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.

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.

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.