Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases

August 11, 2020 updated by: Mayo Clinic

RF Ablation of Painful Metastases Involving Bone

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
    • Texas
      • Houston, Texas, United States, 77030-4009
        • University of Texas - MD Anderson Cancer Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • More than 2 months

Hematopoietic:

  • Platelet count at least 75,000/mm3

Hepatic:

  • INR less than 1.5

Renal:

  • Not specified

Other:

  • Not pregnant or nursing
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 3 weeks since prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 3 weeks since prior radiotherapy

Surgery:

  • Not specified

Other:

  • At least 3 days since prior aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs
  • No concurrent anticoagulants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Study Chair: J. William Charboneau, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2000

Primary Completion (Actual)

October 24, 2002

Study Completion (Actual)

October 24, 2002

Study Registration Dates

First Submitted

January 4, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

August 12, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069180
  • RITA-201-00
  • MAYO-IRB-O-1223-00
  • MDA-ID-01534
  • RITA-IDE-G000177

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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