RF Ablation of Painful Metastases Involving Bone
- 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.
Primary Purpose: Supportive Care
J. William Charboneau, MD
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|St. Luke's Medical Center||Milwaukee, Wisconsin 53215|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Northwestern Memorial Hospital||Chicago, Illinois 60611|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|