Safety and Efficacy of Cryoablation for the Palliation of Painful Bone Metastases
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Cryoablation for the Palliation of Painful Bone Metastases|
- Difference in worst pain scores [ Time Frame: 24 weeks post-cryoablation ] [ Designated as safety issue: No ]The endpoint for this study will be measured as follows: assessment of the effectiveness of cryoablation associated with palliation of pain in subjects with metastatic bone cancer by measuring the average difference of pre- and posttreatment worst pain in 24 hours from baseline to 24 hour, 1, 4, 12, and 24 week follow-up intervals as measured on the numeric 0 to 10 Brief Pain Inventory (BPI) scale.
- Cryoablation retreatments [ Time Frame: 24 weeks post-cryoablation ] [ Designated as safety issue: No ]If the first cryoablation procedure effectively relieves pain but the relief wears off over time and the pain becomes unbearable, a second procedure may be performed. The number of repeat cryoablation treatments will be recorded.
- Additional surgical treatments other than cryoablation [ Time Frame: 24 weeks post-cryoablation ] [ Designated as safety issue: No ]If pain is not effectively relieved by the cryoablation, other surgical treatments may be performed. The number of these treatments will be recorded.
- Reduced analgesic usage [ Time Frame: 24 weeks post-cryoablation ] [ Designated as safety issue: No ]The number of subjects (percentage) who are able to reduce analgesic medications from baseline to 24 hours, 1, 4, 12, and 24 weeks after cryoablation will be recorded.
- Time to maximal palliation of pain after cryoablation [ Time Frame: 24 weeks post-cryoablation ] [ Designated as safety issue: No ]The difference in pain scores will be assessed from baseline to follow-up intervals after cryoablation will be analyzed. The interval indicating the most relief from pain will be compared across subjects.
- Subject satisfaction with the amount palliation of pain obtained from cryoablation [ Time Frame: 24 weeks post-cryoablation ] [ Designated as safety issue: No ]Subject satisfaction will be compared at baseline to follow-up intervals.
- Number of adverse events [ Time Frame: 30 days post-cryoablation ] [ Designated as safety issue: Yes ]The safety endpoint for this study is to assess the incidence and severity of intra-operative events, post operative adverse events, serious adverse events and unanticipated adverse device effects related to the cryoablation procedure.
- Difference in average pain scores [ Time Frame: 24 weeks post-cryoablation ] [ Designated as safety issue: No ]Difference in average pain scores from baseline to 24 hours, 1, 4, 12, and 24 weeks after cryoablation as measured on the numeric 0 to 10 BPI scale
- Time to recurrence of worst pain [ Time Frame: 24 weks post-cryoablation ] [ Designated as safety issue: No ]Time to recurrence of worst pain at or above baseline; worst pain score in the 24 week follow-up period as measured on the numeric 0 to 10 BPI scale
|Study Start Date:||November 2011|
|Study Completion Date:||April 2015|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
All subjects will have cryoablation on one or two painful metastatic bone tumors.
For cryoablation in the palliation of painful bone metastases, subject preparation, anesthesia, intra-operative monitoring, and postoperative management are identical to those of standard cryoablation routinely performed at all clinical centers participating in this study and are at the discretion of the investigator.
Patients with painful bone metastases who meet the eligibility criteria and who have been determined to be an appropriate candidate for cryoablation therapy will be offered enrollment into the study. Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal) and urology (kidney).
Patients agreeing to participate will read and sign an informed consent form and thus become subjects in the study. Treatment will be performed using a Galil Medical cryoablation system and Galil Medical cryoablation needles. Subjects will be followed for up to 24 weeks (6 months) for palliation of pain, quality of life and analgesic usage. Baseline and follow-up data will be collected for each subject via a web-based electronic data collection tool.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461265
|United States, Michigan|
|Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, Texas|
|University of Texas M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada, V5Z 1L8|
|University Hospital of Strasbourg|
|Strasbourg, France, F-67091|
|Study Chair:||Jerry Matteo, MD||Shands Medical Center, Jacksonville, FL|