Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2002 by National Cancer Institute (NCI). Recruitment status was Active, not recruiting

First Received on January 4, 2002. Last Updated on February 6, 2009 History of Changes

Sponsor:	RITA Medical Systems
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00029029

Purpose

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 Pain	Procedure: pain therapy Procedure: radiofrequency ablation	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

October 2000

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029029

Locations

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

RITA Medical Systems

Investigators

Study Chair:

J. William Charboneau, MD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00029029 History of Changes
Other Study ID Numbers:	CDR0000069180, RITA-201-00, MAYO-IRB-O-1223-00, MDA-ID-01534, RITA-IDE-G000177
Study First Received:	January 4, 2002
Last Updated:	February 6, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

bone metastases
pain

Additional relevant MeSH terms:

Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on February 12, 2012