NCT01767935

Cryosurgery and Radiation Therapy in Treating Patients With Painful Bone Metastases

A Pilot Study of The Tandem Treatment of Painful Osseous Metastases With Cryoablation Followed by Radiation Therapy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Bone Metastases
• Pain

Interventions

Type	Name	Description
PROCEDURE	cryosurgery	Undergo cryosurgery
RADIATION	radiation therapy	Undergo radiation therapy
PROCEDURE	quality-of-life assessment	Ancillary studies

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-01-15
• Last updated: 2018-11-14
• Results posted: 2017-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study