Recruiting

Kyphoplasty, Radiofrequency Ablation, Radiation Therapy

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT07479199

Conditions

Thoracic Neoplasms

Lumbar Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

kyphoplasty with Osteocool

Study Details

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

Thoracic Neoplasms

Lumbar Neoplasm

Study ID

NCT07479199

Start date

Mar 16, 2026

Status verified date

Apr, 2026

Completion date

Mar 1, 2031

Anticipated

Primary completion date

Mar 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

kyphoplasty with Osteocool

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

Primary outcome measure

  • Change in pain intensity [ Time Frame: Baseline and at 3 months (1 months after completion of radiotherapy) ]

Central Contacts and Locations

Central contacts

Markeela Lipscomb

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

Desma Jones

desma_jones@med.unc.edu

Locations

UNC Hospitals

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Markeela Lipscomb

919-843-9463markeela_lipscomb@med.unc

Desma Jones

919-984-0000ddesma_jones@med.unc.edu

Principal Investigator:

Nicole A Keefe, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-04-23.