RF Ablation of Painful Metastases Involving Bone
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:
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.
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:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other: