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

Официальное название

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

Обзор

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).

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (8)

• Presence of thoracic and lumbar spine tumors [Срок оценки: at 3- and 6-months following procedure]
• Long term new or worsened vertebral body compression fracture [Срок оценки: at 6 months following procedure]
• Retreatment of thoracic and lumbar spine tumor [Срок оценки: at 6 months following procedure]
• Quality of life per Patient-Reported Outcomes version of the Common Terminology Criteria [Срок оценки: Baseline and at 6 months following procedure]
• Pain level [Срок оценки: Baseline and at 6 months following procedure]
• Readmission rate [Срок оценки: Up to 6 months following procedure]
• Narcotic pain medication [Срок оценки: Up to 6 months following procedure]
• Grade 2 or higher Adverse Events [Срок оценки: Up to 1 month]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• UNC Hospitals — Chapel Hill

Идентификаторы

NCT: NCT07479199 · LCCC2336

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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