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Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00029029
First received: January 4, 2002
Last updated: October 30, 2014
Last verified: October 2014

January 4, 2002
October 30, 2014
October 2000
October 2002   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00029029 on ClinicalTrials.gov Archive Site
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Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases
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.

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.

Interventional
Phase 2
Primary Purpose: Supportive Care
  • Metastatic Cancer
  • Pain
  • Procedure: pain therapy
  • Procedure: radiofrequency ablation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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October 2002   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00029029
CDR0000069180, RITA-201-00, MAYO-IRB-O-1223-00, MDA-ID-01534, RITA-IDE-G000177
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Mayo Clinic
Mayo Clinic
Not Provided
Study Chair: J. William Charboneau, MD Mayo Clinic
Mayo Clinic
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP