Percutaneous Cryoablation in Treating Patients With Painful Bone Metastases
Recruitment status was Active, not recruiting
RATIONALE: Percutaneous cryoablation may help relieve pain caused by bone metastases.
PURPOSE: This clinical trial is studying the side effects and how well percutaneous cryoablation works in treating patients with painful bone metastases.
Unspecified Adult Solid Tumor, Protocol Specific
Other: questionnaire administration
Procedure: pain therapy
Procedure: quality-of-life assessment
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Percutaneous US and CT-Guided Cryoablation of Painful Metastases Involving Bone: A Feasibility Study|
- Average difference in pre- and post-treatment worst pain score in a 24-hour period at week 8 [ Designated as safety issue: No ]
- Average difference in pre- and post-treatment worst pain score in a 24-hour period, average pain score, and pain relief score at 6, 12, and 24 months [ Designated as safety issue: No ]
- Average amount of pain per patient over the observation period as represented by the area under the curve (AUC) constructed from weekly pain scores on a visual-analogue scale using a score of 0-10 [ Designated as safety issue: No ]
- Percentage of patients who are able to reduce analgesic medications [ Designated as safety issue: No ]
|Study Start Date:||November 2003|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
- To confirm the safety of percutaneous cryoablation in the palliative treatment of patients with painful bone metastases.
- To determine the benefits of cryoablation of painful bone metastases by assessing pain intensity using a standardized Cleeland Brief Pain Inventory (BPI) and quality of life using a standardized SF-8 both before and after treatment.
- To determine the secondary benefits of cryoablation of painful bone metastases by assessing change in analgesic use following therapy.
- To determine the level of anesthesia required for cryoablation with a baseline level of conscious sedation planned for each treatment.
OUTLINE: This is a multicenter study.
Patients undergo percutaneous cryoablation to one or two sites of metastatic disease using the Endocare Cryocare system. Patients with a good initial response to treatment (≥ 2 decrease in pain intensity rating on the Brief Pain Inventory) who develop recurrent pain at the same site or a new painful site ≥ 1 month after initial treatment may undergo one additional cryoablation treatment.
Patients complete pain and quality of life questionnaires periodically.
After completion of study treatment, patients are followed periodically for 2 years.
|United States, Florida|
|Mayo Clinic - Jacksonville|
|Jacksonville, Florida, United States, 32224|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0942|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|NYU Cancer Institute at New York University Medical Center|
|New York, New York, United States, 10016|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|United States, Rhode Island|
|Brown University School of Medicine|
|Providence, Rhode Island, United States, 02912|
|United States, Wisconsin|
|University of Wisconsin Paul P. Carbone Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792-6164|
|Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center|
|Milwaukee, Wisconsin, United States, 53215|
|Study Chair:||Matthew R. Callstrom, MD, PhD||Mayo Clinic|
|Investigator:||Thomas D. Atwell, MD||Mayo Clinic|
|Investigator:||Matthew P. Goetz, MD||Mayo Clinic|
|Investigator:||J. William Charboneau, MD||Mayo Clinic|
|Investigator:||Joseph Rubin, MD||Mayo Clinic|
|Investigator:||Michael A. Farrell||Mayo Clinic|
|Investigator:||Timothy P. Maus, MD||Mayo Clinic|
|Investigator:||Timothy J. Welch, MD||Mayo Clinic|
|Investigator:||Douglas A. Nichols, MD||Mayo Clinic|
|Investigator:||Yolanda I. Garces, MD||Mayo Clinic|