Radiofrequency Ablation in Treating Patients With Bone Metastases
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Primary Completion Date :||February 2011|
- Adverse events
- Pain intensity as assessed by the Memorial Pain Assessment Cards
- Pain relief
- Pain severity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|