Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone
University of Minnesota
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Have adequate organ function confirmed by the following laboratory values obtained within 14 days prior to study enrollment defined as: 1. absolute neutrophil count (ANC) ≥ 1.5 × 109/L 2. platelets ≥ 50 × 109/L 3. hemoglobin ≥ 10 g/dL, independent of transfusion ≤14 days of screening…
Interventions
- ProcedureRadiofrequency ablation and bone augmentation with radiotherapy
employs radiofrequency-generated heat to eradicate cancer cells, followed by the application of a bone-stabilizing agent
- ProcedureRadiotherapy alone
High-energy radiation
Location
- University of MinnesotaMinneapolis, Minnesota