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Sponsored by: |
RITA Medical Systems |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00029029 |
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: | Supportive Care |
Official Title: | RF Ablation of Painful Metastases Involving Bone |
Study Start Date: | October 2000 |
OBJECTIVES:
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 and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Tumors must be more than 1 cm from critical structures including:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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 |
Study Chair: | J. William Charboneau, MD | Mayo Clinic |
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: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00029029 |
Health Authority: | United States: Federal Government |
bone metastases pain |
Neoplasm Metastasis Pain |
Neoplasms Neoplastic Processes Pathologic Processes |