A Multi-Center Observational Trial of Symptomatic, High-Risk Bone Metastases Treated With Percutaneous Ablation and Palliative Radiation Therapy
Summary
The objective of this study is to evaluate real-world outcomes (e.g., pain, patient reported outcomes, skeletal related events, healthcare utilization, etc.) in patients treated with both percutaneous ablation and palliative radiation therapy (RT).
Arms & interventions
- DevicePercutaneous Ablation
Percutaneous ablation is a minimally invasive alternative therapy for metastatic bone disease and can be used for destruction of nerves mediating pain signals, tumor destruction, decompression, or inhibition of tumor growth.
- RadiationRadiation Therapy
Radiation therapy (RT) is a widely accepted treatment for painful bone metastases and provides palliation of pain for patients.
Outcome measures
Primary
Pain Response
Combined partial and complete pain response rate using the Brief Pain Inventory (BPI), worst pain 24-hour recall, at 3 months following percutaneous ablation and palliative RT as defined by International Consensus on Palliative Radiotherapy Endpoints in clinical trials (ICPRE). • Partial response is defined as pain reduction of 2 or more at the treated site on a scale of 0 to 10 scale without analgesic increase, or analgesic reduction of 25% or more from Baseline without an increase in pain. • Complete response is defined as a pain score of 0 at the treated site with no concomitant increase in analgesic intake (stable or reducing analgesics in daily OMED).
Time frame: 3 Months
Eligibility criteria
Study locations (7)
University of California San Diego Moores Cancer Center
San Diego, California, 92093
Baptist Health Medical Group
Miami, Florida, 33176
Emory University Hospital
Atlanta, Georgia, 30322
Northside Hospital
Atlanta, Georgia, 30342
Mayo Clinic
Rochester, Minnesota, 55905
Washington University
St Louis, Missouri, 63110
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226