Radiofrequency Ablation in Treating Patients With Bone Metastases
|ClinicalTrials.gov Identifier: NCT00026247|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 8, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Pain Unspecified Adult Solid Tumor, Protocol Specific||Procedure: pain therapy Procedure: radiofrequency ablation||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Percutaneous Radiofrequency Ablation of Bone Metastases Using CT Guidance|
|Study Start Date :||November 2001|
|Actual Primary Completion Date :||February 2011|
- Adverse events
- Pain intensity as assessed by the Memorial Pain Assessment Cards
- Pain relief
- Pain severity
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026247
|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|