Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases

Study Overview
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Brief Summary
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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
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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.

Official Title
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RF Ablation of Painful Metastases Involving Bone

Conditions
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Metastatic Cancer, Pain

Intervention / Treatment
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* Procedure: pain therapy
* Procedure: radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: pain therapy|nan|
|Procedure: radiofrequency ablation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, bone metastases