Radiofrequency Ablation in Treating Patients With Bone Metastases

Pain Clinical Trial

— ACRIN-6661  

Official title:

A Phase I/II Study of Percutaneous Radiofrequency Ablation of Bone Metastases Using CT Guidance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00026247
• Other study ID #: CDR0000069012
• Secondary ID: ACRIN-6661U01CA0
• Status: Completed
• Phase: N/A
• Start date: November 2001
• Est. completion date: February 15, 2010

Study information

• Verified date: July 2019
• Source: American College of Radiology Imaging Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 15, 2010
• Est. primary completion date: February 15, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 120 Years

Eligibility

4.1 Inclusion Criteria

4.1.1 Histologically or cytologically documented malignant disease with a bone lesion that has the clinical and/imaging features of metastatic disease.

4.1.2 Persistent intractable pain that results in a return visit to the oncologist. The measurable pain must be above a pain scale of five (scale of 0-10). (Pain during the last week described as "the worst" by the patient on a scale of 0 (no pain) to 10 (pain as bad as patient can imagine)).

4.1.3 The patient's pain must be from a solitary site of metastatic disease in the bone. Each site must be amenable to RFA utilizing a percutaneous CT-guided approach. (RF electrode can be safely placed under CT guidance without harm to normal structures.) 4.1.4 The maximum size of the bone metastasis (study site) must be no greater than 8 cm.

4.1.5 Radiofrequency treatment can be performed within 5 days of baseline evaluations.

4.1.6 All patients must understand and sign a study-specific informed consent.

4.2 Exclusion Criteria

4.2.1 Tumor mass in contact with hollow viscera. 4.2.2 Uncontrolled coagulopathy or bleeding diathesis that cannot be corrected with FFP and platelets prior to procedure. (Platelets must be = 70,000/ul.) 4.2.3 Aspirin and nonsteroidal anti-inflammatory medications, antiplatelet medications, or warfarin must be discontinued prior to the procedure for a time period that is appropriate given the drug half life and the drugs known antiplatelet activity (e.g. aspirin for 7 days and ibuprofen 24 hours). Low molecular weight heparin preparations must be discontinued 24 hours prior to procedure.

4.2.4 Tumor involves a weight-bearing long-bone of the lower extremity. 4.2.5 Site of tumor surgically stabilized with metallic hardware. 4.2.6 Previous (within 30 days immediately prior to RFA or post RFA) or scheduled concurrent systemic treatment of metastases with external beam radiation or radioisotopes. (Chemotherapy will not be allowed within 14 days prior to and within 14 days post RFA procedure).

4.2.7 Patients with primary musculoskeletal malignancies, lymphoma and leukemia will not be RFA treatment candidates.

4.2.8 Spinal metastases that do not have an intact cortex between the mass and the spinal canal and exiting nerve roots.

4.2.8 Patients with a pacemaker.

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Pain
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Procedure:
• pain therapy

• radiofrequency ablation

Locations

Country	Name	City	State
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	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	Mallinckrodt Institute of Radiology at Washington University Medical Center	Saint Louis	Missouri
United States	UMASS Memorial Cancer Center - University Campus	Worcester	Massachusetts
United States	Radiology Consultants, Incorporated	Youngstown	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
American College of Radiology Imaging Network	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dupuy DE, Liu D, Hartfeil D, Hanna L, Blume JD, Ahrar K, Lopez R, Safran H, DiPetrillo T. Percutaneous radiofrequency ablation of painful osseous metastases: a multicenter American College of Radiology Imaging Network trial. Cancer. 2010 Feb 15;116(4):989 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Estimate the adverse event rate due to RFA within 1 month follow-up period.	1 month post procedure
Secondary	Pain intensity	pain intensity as measured by VASPI Scale	1 month post-procedure
Secondary	Pain intensity	pain intensity as measured by VASPI Scale	3 months post-procedure
Secondary	Pain reduction	pain reduction as measured by VASPR Scale	1 month post-procedure
Secondary	Pain reduction	pain reduction as measured by VASPR Scale	3 month post-procedure
Secondary	Mood	Mood as measured byt the VASMOOD scale	1 month post-procedure
Secondary	Mood	Mood as measured by the VASMOOD scale	3 month post-procedure
Secondary	Pain Severity	Pain severity as measured by the Tursky scale	1 month post-procedure
Secondary	Pain Severity	Pain severity as measured by the Tursky scale	3 month post-procedure