Study Stopped
Low accrual
Low accrual
A Phase III Randomized Trial of Cryoablation vs. Radiation for the Palliation of Painful Bone Metastases
Sponsor study identifier
Secondary identifiers
REGISTRY · CTRP (Clinical Trials Reporting System)
REGISTRY · PDQ (Physician Data Query)
interventional
3
1 country
7
Study Start
February 2008
Actual (reported)Primary Completion
January 2010
Actual (reported)Study Completion
January 2010
Actual (reported)RATIONALE: Cryoablation kills cancer cells by freezing them. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether cryoablation is more effective than external-beam radiation therapy in treating painful bone metastases. PURPOSE: This randomized phase III clinical trial is studying cryoablation to see how well it works compared with external-beam radiation therapy in treating patients with painful bone metastases.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 5, 2007
Actual (reported)October 8, 2007
Actual (reported)February 2008
Actual (reported)January 2010
Actual (reported)January 2010
Actual (reported)February 1, 2017
Actual (reported)Comparison of Pre- and Post-treatment Worst Pain in 24 Hours at Week 6 as Measured on the Numeric 0 to 10 Brief Pain Inventory (BPI) Scale
at week 6
Average Difference in Pre- and Post-treatment Average Pain, Pain Relief, and Pain Interference Scores at Week 6 as Measured With the BPI
at week 6
Average Difference in Pre- and Post-treatment Physical (PCS-8) and Mental (MCS-8) Quality of Life at Week 6 as Measured by the 2 Subscales of the Short Form (SF)-8
at week 6
Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.
Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.
Patients undergo cryosurgery using guidance from CT scan or ultrasound
Patients undergo radiotherapy for 1 week
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin Cancer Center
Matthew R. Callstrom, MD, PhD
Mayo Clinic
3 participants (actual enrollment reported by the registry).
First Submitted
October 5, 2007
First Posted
October 8, 2007
Study Start
February 2008
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
Milwaukee, Wisconsin, 53226, United States
January 2010
Actual (reported)Study Completion
January 2010
Actual (reported)Last Updated
November 21, 2018
Results First Posted
February 1, 2017
Record last verified: 2018-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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