Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota
About this trial
This is a single-center, randomized controlled pilot study of radiofrequency ablation and bone augmentation (RFA/BA) plus radiotherapy (RT) vs. RT alone in patients with metastatic T5-L5 disease of the spine. Patients will be randomized 2:1 to receive either one treatment of RFA/BA plus RT or RT to evaluate the occurrence of skeletal-related events. Skeletal-related events (SREs) are defined as new clinical or radiologic evidence of pathologic fracture, spinal cord or nerve root compression, pain or instability, and/or necessity for additional local intervention (i.e. surgery, repeat RFA/BA or RT) due to persistent or progressive symptoms. Post-treatment follow-up for SREs are assessed at 1, 3, 6, 12, and 24 months.
Eligibility criteria
Qualifiers
Histologically confirmed metastatic T5-L5 disease of the spine (with up to two levels) as detected by any imaging study.
Have either associated bone pain or cross-sectional imaging characteristics that are predictors of SRE.
Age 18 years of age or older at the time of consent.
absolute neutrophil count (ANC) ≥ 1.5 × 109/L
Disqualifiers
Pregnant or breastfeeding.
Clinical or radiologic evidence of epidural spinal cord compression or radicular pain.
Prior radiation therapy to the target lesion.
Candidates for spine stabilization surgery.
Trial design
Treatments tested in this trial
- Radiofrequency ablation and bone augmentation with radiotherapy
- Radiotherapy alone
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov