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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Ablation | Device | 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. | ||
| Radiation Therapy | Radiation | Radiation therapy (RT) is a widely accepted treatment for painful bone metastases and provides palliation of pain for patients. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with previously untreated symptomatic, high-risk skeletal metastases who are scheduled to be treated with percutaneous ablation combined with palliative RT as part of their normal Standard of Care (SOC).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego Moores Cancer Center | Recruiting | San Diego | California | 92093 | United States |
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| Baptist Health Medical Group | Recruiting | Miami | Florida | 33176 | United States |
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| Emory University Hospital | Recruiting | Atlanta | Georgia | 30322 | United States |
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| Northside Hospital | Recruiting | Atlanta | Georgia | 30342 | United States |
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| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Washington University | Recruiting | St Louis | Missouri | 63110 | United States |
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| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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