This pilot clinical trial studies cryosurgery and radiation therapy in treating patients with painful bone metastases. Cryosurgery kills tumor cells by freezing them. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Giving cryosurgery together with radiation therapy may kill more tumor cells
PRIMARY OBJECTIVES: I. To assess the potential for efficacy and safety of combining percutaneous computed tomography (CT)-guided cryoablation and radiotherapy for the palliation of osseous metastases. OUTLINE: Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 24 hours and weeks 1-2, 4, 12, 18, and 24.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Undergo cryosurgery
Undergo radiation therapy
Ancillary studies
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Pain Level at 24 Hours Before Cryosurgery, as Measured by the BPI
Numerical scores (0-10) from the BPI will be used to measure pain levels. Higher scores denotes worse outcome.
Time frame: 24 hours
Pain Medication Level, Assessed by Changes in Narcotic Medication Usage
Pain medication assessments will be used to quantify any change in narcotic medication usage using the 24-hour morphine equivalent dose.
Time frame: Baseline to 24 weeks
Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Time frame: Up to 24 weeks
Pain After Cryosurgery, as Measured by the BPI
Questions #4 (least pain), #5 (average pain), and #6 (right now) from the BPI (reported on 0-10 scale) will be used as the secondary outcome measures. Higher scores denotes worse outcome
Time frame: Up to 24 weeks
Number of Participants Who Survived
Count of participants that survived.
Time frame: Up to 24 weeks post-cryosurgery
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