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Brief Title: Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases
Official Title: RF Ablation of Painful Metastases Involving Bone
Study ID: NCT00029029
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.
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Northwestern Memorial Hospital, Chicago, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
St. Luke's Medical Center, Milwaukee, Wisconsin, United States
Name: J. William Charboneau, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR