Radiofrequency Ablation in Treating Patients With Bone Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00026247
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 8, 2011
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Pain Unspecified Adult Solid Tumor, Protocol Specific Procedure: pain therapy Procedure: radiofrequency ablation Phase 1 Phase 2

Detailed Description:


  • 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Percutaneous Radiofrequency Ablation of Bone Metastases Using CT Guidance
Study Start Date : November 2001
Actual Primary Completion Date : February 2011

Primary Outcome Measures :
  1. Adverse events

Secondary Outcome Measures :
  1. Pain intensity as assessed by the Memorial Pain Assessment Cards
  2. Pain relief
  3. Pain severity
  4. Mood

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed malignant disease with a bone lesion that appears to be metastatic disease by clinical and/or imaging techniques
  • Persistent intractable pain from a solitary site of bone metastases (greater than 5 on pain scale of 0-10)
  • Bone metastasis must be amenable to radiofrequency ablation using a percutaneous CT-guided approach
  • Bone metastasis must be no greater than 8 cm
  • No tumor mass in contact with hollow viscera
  • No primary musculoskeletal malignancies, lymphoma, or leukemia
  • No spinal metastases that do not have an intact cortex between the mass and the spinal canal and exiting nerve roots
  • No tumor involving weight-bearing long bone of lower extremity or impending fracture



  • 21 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Platelet count at least 70,000/mm^3
  • No uncontrolled coagulopathy or bleeding diathesis that cannot be corrected with fresh frozen plasma and platelets


  • Not specified


  • Not specified


  • No pacemaker


Biologic therapy:

  • Not specified


  • At least 14 days since prior chemotherapy for metastatic disease
  • No concurrent systemic chemotherapy for metastatic disease during and for 14 days after study therapy

Endocrine therapy:

  • Not specified


  • At least 30 days since prior radioisotopes for metastatic disease
  • No concurrent systemic radioisotopes for metastatic disease


  • No surgical stabilization of tumor site with metallic hardware


  • Prior aspirin, nonsteroidal anti-inflammatory medications, antiplatelet medications, or warfarin must be discontinued for an appropriate period of time prior to study based on the drug's half-life and known antiplatelet activity (e.g., 7 days for aspirin and 24 hours for ibuprofen)
  • At least 24 hours since prior low molecular weight heparin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00026247

United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Massachusetts
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Missouri
Mallinckrodt Institute of Radiology at Washington University Medical Center
St. Louis, Missouri, United States, 63110
United States, Ohio
Radiology Consultants, Incorporated
Youngstown, Ohio, United States, 44512
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
United States, Rhode Island
Comprehensive Cancer Center at Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Study Chair: Damian E. Dupuy, MD Rhode Island Hospital

Publications of Results: Identifier: NCT00026247     History of Changes
Other Study ID Numbers: CDR0000069012
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 8, 2011
Last Verified: March 2006

Keywords provided by National Cancer Institute (NCI):
bone metastases
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes