Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone Metastases
Patients with painful bone metastases who meet the eligibility criteria and who have been
determined to be an appropriate candidate for cryoablation therapy and radiation 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). Radiation therapy, also called
radiotherapy, uses carefully targeted doses of high-energy radiation to kill cancer cells.
Radiation is used to treat many kinds of cancer.
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Difference in worst pain scores
The endpoint for this study will be measured as follows: assessment of the effectiveness of cryoablation combined with radiation 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.
24 weeks post cryoablation
Jerry Matteo, MD
Shands Medical Center, Jacksonville, FL
United States: Institutional Review Board
|University of California, San Diego||La Jolla, California 92037-1709|
|Washington University St. Louis||St. Louis, Missouri 63110|