Radiofrequency Ablation in Treating Patients With Bone Metastases

Not Applicable

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Pain; Metastatic Cancer

• Registration Number: NCT00026247
• Lead Sponsor: American College of Radiology Imaging Network

Brief Summary

RATIONALE: Radiofrequency ablation may be effective in decreasing pain from bone metastases.

PURPOSE: Phase I/II trial to study the effectiveness of radiofrequency ablation in decreasing pain in patients who have bone metastases.

Detailed Description

OBJECTIVES:

* Determine the side effects of radiofrequency ablation in patients with bone metastases.

* Determine the effect of this regimen on pain in these patients.

* Determine the effect of this regimen on mood in these patients.

* Determine the effects of narcotic usage in patients treated with this regimen.

* Determine the relationship between laboratory and imaging features of this treatment and the effects of the treatment in these patients.

OUTLINE: This is a multicenter study.

Patients undergo percutaneous CT-guided radiofrequency ablation directly to the metastatic lesion over approximately 12 minutes.

Pain and mood are assessed at baseline, daily for 14 days after treatment, and at 1 and 3 months after treatment.

Patients are followed at 1 week and then at 1 and 3 months.

PROJECTED ACCRUAL: Approximately 75 patients will be accrued for this study within 12.5 months.

Study Timeline

• Study Start: 2001-11
• Study First Submitted: 2001-11-09
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2010-02-15
• Study Completion: 2010-02-15
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adverse events	1 month post procedure	Estimate the adverse event rate due to RFA within 1 month follow-up period.

Secondary Outcome Measures

Name	Time	Method
Pain intensity	3 months post-procedure	pain intensity as measured by VASPI Scale
Pain reduction	3 month post-procedure	pain reduction as measured by VASPR Scale
Mood	3 month post-procedure	Mood as measured by the VASMOOD scale
Pain Severity	3 month post-procedure	Pain severity as measured by the Tursky scale

Trial Locations

Locations (8)

Comprehensive Cancer Center at University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

UMASS Memorial Cancer Center - University Campus; 🇺🇸 Worcester, Massachusetts, United States

Mallinckrodt Institute of Radiology at Washington University Medical Center; 🇺🇸 Saint Louis, Missouri, United States

Radiology Consultants, Incorporated; 🇺🇸 Youngstown, Ohio, United States

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Comprehensive Cancer Center at Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States

M.D. Anderson Cancer Center at University of Texas; 🇺🇸 Houston, Texas, United States