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Recruiting NCT07479199

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

— Observational Thoracic Neoplasms Lumbar Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: kyphoplasty with Osteocool.
Who it may be relevant to
Registry conditions: Thoracic Neoplasms, Lumbar Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

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

Primary outcome measures

  • Change in pain intensity [Time frame: Baseline and at 3 months (1 months after completion of radiotherapy)]
Secondary outcome measures (8)
  • Presence of thoracic and lumbar spine tumors [Time frame: at 3- and 6-months following procedure]
  • Long term new or worsened vertebral body compression fracture [Time frame: at 6 months following procedure]
  • Retreatment of thoracic and lumbar spine tumor [Time frame: at 6 months following procedure]
  • Quality of life per Patient-Reported Outcomes version of the Common Terminology Criteria [Time frame: Baseline and at 6 months following procedure]
  • Pain level [Time frame: Baseline and at 6 months following procedure]
  • Readmission rate [Time frame: Up to 6 months following procedure]
  • Narcotic pain medication [Time frame: Up to 6 months following procedure]
  • Grade 2 or higher Adverse Events [Time frame: Up to 1 month]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • UNC Hospitals — Chapel Hill

Identifiers

NCT: NCT07479199 · LCCC2336

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗