Radiofrequency Ablation in Treating Patients With Bone Metastases

Not Applicable

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Pain; Metastatic Cancer
• Interventions: Procedure: pain therapy; Procedure: radiofrequency ablation

• 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

Arm && Interventions

Group	Intervention	Description
RFA as pain therapy	pain therapy	Changes in the severity of pain as measured using using the Memorial Pain Assessment Cards (MPAC) before and after RadioFrequency Ablation (RFA) will be statistically analyzed
RFA as pain therapy	radiofrequency ablation	Changes in the severity of pain as measured using using the Memorial Pain Assessment Cards (MPAC) before and after RadioFrequency Ablation (RFA) will be statistically analyzed

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)

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

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

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