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Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Mayo Clinic Identifier:
First received: January 4, 2002
Last updated: April 18, 2016
Last verified: January 2016

RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells and may help to relieve pain caused by bone metastases.

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

Condition Intervention Phase
Metastatic Cancer
Procedure: pain therapy
Procedure: radiofrequency ablation
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care
Official Title: RF Ablation of Painful Metastases Involving Bone

Further study details as provided by Mayo Clinic:

Study Start Date: October 2000
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Detailed Description:


  • Determine the efficacy of radiofrequency ablation, in terms of pain relief at 4 weeks, in patients with painful bone metastases.
  • Determine the safety of this regimen in these patients.
  • Compare the change in pain interference with daily life and analgesic use at 4 weeks vs baseline in patients treated with this regimen.
  • Determine the time to recurrence of worst pain in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive radiofrequency ablation (RFA) to targeted tumor(s) on day 0 (multiple tumors may receive ablation in multiple sessions). Patients who achieve a reduction in worst pain of at least 2 points within 4-8 weeks but experience recurring pain at the RFA site or are diagnosed with a new painful lesion within 4-24 weeks receive 1 additional treatment to the recurring or new site.

Pain (using the Brief Pain Inventory scale of 0-10), analgesic use, and quality of life are assessed at baseline, on day 1, weekly for 4 weeks, and then every 2 weeks for 20 weeks.

Patients are followed for 6 months beyond the last RFA treatment.

PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed bone metastases
  • Pain refractory to non-opioid analgesic medication and radiotherapy OR
  • Patient is considered a poor candidate for opioid analgesics or radiotherapy
  • Initial worst pain score within the past 24 hours at least 4 on a scale of 0-10
  • Tumors deemed accessible for radiofrequency ablation
  • No evidence of impending fracture in weight-bearing bones (more than 50% loss of cortical bone)
  • Tumors must be more than 1 cm from critical structures including:

    • Spinal cord, brain, or other critical nerve structures
    • Large abdominal vessel (e.g., aorta or inferior vena cava)
    • Bowel or bladder



  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • More than 2 months


  • Platelet count at least 75,000/mm3


  • INR less than 1.5


  • Not specified


  • Not pregnant or nursing
  • Negative pregnancy test


Biologic therapy:

  • Not specified


  • At least 3 weeks since prior chemotherapy

Endocrine therapy:

  • Not specified


  • At least 3 weeks since prior radiotherapy


  • Not specified


  • At least 3 days since prior aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs
  • No concurrent anticoagulants
  Contacts and Locations
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Please refer to this study by its identifier: NCT00029029

United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Wisconsin
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Mayo Clinic
Study Chair: J. William Charboneau, MD Mayo Clinic
  More Information

Responsible Party: Mayo Clinic Identifier: NCT00029029     History of Changes
Other Study ID Numbers: CDR0000069180
Study First Received: January 4, 2002
Last Updated: April 18, 2016

Keywords provided by Mayo Clinic:
bone metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes processed this record on April 26, 2017