Radiofrequency Ablation in Treating Patients With Bone Metastases
RATIONALE: Radiofrequency ablation may be effective in decreasing pain from bone metastases.
PURPOSE: Phase I/II trial to study the effectiveness of radiofrequency ablation in decreasing pain in patients who have bone metastases.
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: pain therapy
Procedure: radiofrequency ablation
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of Percutaneous Radiofrequency Ablation of Bone Metastases Using CT Guidance|
- Adverse events [ Designated as safety issue: Yes ]
- Pain intensity as assessed by the Memorial Pain Assessment Cards [ Designated as safety issue: No ]
- Pain relief [ Designated as safety issue: No ]
- Pain severity [ Designated as safety issue: No ]
- Mood [ Designated as safety issue: No ]
|Study Start Date:||November 2001|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
- Determine the side effects of radiofrequency ablation in patients with bone metastases.
- Determine the effect of this regimen on pain in these patients.
- Determine the effect of this regimen on mood in these patients.
- Determine the effects of narcotic usage in patients treated with this regimen.
- Determine the relationship between laboratory and imaging features of this treatment and the effects of the treatment in these patients.
OUTLINE: This is a multicenter study.
Patients undergo percutaneous CT-guided radiofrequency ablation directly to the metastatic lesion over approximately 12 minutes.
Pain and mood are assessed at baseline, daily for 14 days after treatment, and at 1 and 3 months after treatment.
Patients are followed at 1 week and then at 1 and 3 months.
PROJECTED ACCRUAL: Approximately 75 patients will be accrued for this study within 12.5 months.
|United States, Alabama|
|Comprehensive Cancer Center at University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, Massachusetts|
|UMASS Memorial Cancer Center - University Campus|
|Worcester, Massachusetts, United States, 01655|
|United States, Missouri|
|Mallinckrodt Institute of Radiology at Washington University Medical Center|
|St. Louis, Missouri, United States, 63110|
|United States, Ohio|
|Radiology Consultants, Incorporated|
|Youngstown, Ohio, United States, 44512|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19107-5541|
|United States, Rhode Island|
|Comprehensive Cancer Center at Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|United States, Texas|
|M.D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Damian E. Dupuy, MD||Rhode Island Hospital|