Clincosm LogoSign in Get a demo

Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00029029
Collaborator
(none)
6
Locations
24.3
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: pain therapy
  • Procedure: radiofrequency ablation
 Phase 2

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 Design

Study Type:
Interventional
Primary Purpose:
Supportive Care
Official Title:
RF Ablation of Painful Metastases Involving Bone
Actual Study Start Date :
Oct 13, 2000
Actual Primary Completion Date :
Oct 24, 2002
Actual Study Completion Date :
Oct 24, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern Memorial Hospital Chicago Illinois United States 60611
    2 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21287
    3 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    4 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
    5 University of Texas - MD Anderson Cancer Center Houston Texas United States 77030-4009
    6 St. Luke's Medical Center Milwaukee Wisconsin United States 53215

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT00029029
    Other Study ID Numbers:
    • CDR0000069180
    • RITA-201-00
    • MAYO-IRB-O-1223-00
    • MDA-ID-01534
    • RITA-IDE-G000177
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Aug 12, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mayo Clinic
    bone metastases
    pain
    Additional relevant MeSH terms:
    Neoplasm Metastasis

    Study Results

    No Results Posted as of Aug 12, 2020