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

UNC Lineberger Comprehensive Cancer Center

Status: Not yet enrolling

Conditions: Thoracic Neoplasms; Lumbar Neoplasm

Treatments: Procedure: kyphoplasty with Osteocool

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07479199

LCCC2336

Details and patient eligibility

About

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).

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

70 participants in 1 patient group

Metastatic thoracic or lumbar spine tumor

Description:

metastatic thoracic or lumbar spine tumor and reported back pain of ≥ 5 on a visual analog scale (VAS) assessments scale.

Treatment:

Procedure: kyphoplasty with Osteocool