Radiofrequency Ablation in Treating Patients With Bone Metastases

Study Overview
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Brief Summary
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RATIONALE: Radiofrequency ablation may be effective in decreasing pain from bone metastases. PURPOSE: Phase I/II trial to study the effectiveness of radiofrequency ablation in decreasing pain in patients who have bone metastases.

Detailed Description
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OBJECTIVES: Determine the side effects of radiofrequency ablation in patients with bone metastases. Determine the effect of this regimen on pain in these patients. Determine the effect of this regimen on mood in these patients. Determine the effects of narcotic usage in patients treated with this regimen. Determine the relationship between laboratory and imaging features of this treatment and the effects of the treatment in these patients. OUTLINE: This is a multicenter study. Patients undergo percutaneous CT-guided radiofrequency ablation directly to the metastatic lesion over approximately 12 minutes. Pain and mood are assessed at baseline, daily for 14 days after treatment, and at 1 and 3 months after treatment. Patients are followed at 1 week and then at 1 and 3 months. PROJECTED ACCRUAL: Approximately 75 patients will be accrued for this study within 12.5 months.

Official Title
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A Phase I/II Study of Percutaneous Radiofrequency Ablation of Bone Metastases Using CT Guidance

Conditions
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Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific

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


Participation Criteria
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Eligibility Criteria
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4.1 Inclusion Criteria 4.1.1 Histologically or cytologically documented malignant disease with a bone lesion that has the clinical and/imaging features of metastatic disease. 4.1.2 Persistent intractable pain that results in a return visit to the oncologist. The measurable pain must be above a pain scale of five (scale of 0-10). (Pain during the last week described as the worst by the patient on a scale of 0 (no pain) to 10 (pain as bad as patient can imagine)). 4.1.3 The patient's pain must be from a solitary site of metastatic disease in the bone. Each site must be amenable to RFA utilizing a percutaneous CT-guided approach. (RF electrode can be safely placed under CT guidance without harm to normal structures.) 4.1.4 The maximum size of the bone metastasis (study site) must be no greater than 8 cm. 4.1.5 Radiofrequency treatment can be performed within 5 days of baseline evaluations. 4.1.6 All patients must understand and sign a study-specific informed consent. 4.2 Exclusion Criteria 4.2.1 Tumor mass in contact with hollow viscera. 4.2.2 Uncontrolled coagulopathy or bleeding diathesis that cannot be corrected with FFP and platelets prior to procedure. (Platelets must be ≥ 70,000/ul.) 4.2.3 Aspirin and nonsteroidal anti-inflammatory medications, antiplatelet medications, or warfarin must be discontinued prior to the procedure for a time period that is appropriate given the drug half life and the drugs known antiplatelet activity (e.g. aspirin for 7 days and ibuprofen 24 hours). Low molecular weight heparin preparations must be discontinued 24 hours prior to procedure. 4.2.4 Tumor involves a weight-bearing long-bone of the lower extremity. 4.2.5 Site of tumor surgically stabilized with metallic hardware. 4.2.6 Previous (within 30 days immediately prior to RFA or post RFA) or scheduled concurrent systemic treatment of metastases with external beam radiation or radioisotopes. (Chemotherapy will not be allowed within 14 days prior to and within 14 days post RFA procedure). 4.2.7 Patients with primary musculoskeletal malignancies, lymphoma and leukemia will not be RFA treatment candidates. 4.2.8 Spinal metastases that do not have an intact cortex between the mass and the spinal canal and exiting nerve roots. 4.2.8 Patients with a pacemaker.

Ages Eligible for Study
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Minimum Age: 21 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: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The outcomes of the study will be adverse event analysis and pain relief.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RFA as pain therapy<br>Changes in the severity of pain as measured using using the Memorial Pain Assessment Cards (MPAC) before and after RadioFrequency Ablation (RFA) will be statistically analyzed | Procedure: pain therapy<br> <br> Procedure: radiofrequency ablation<br> <br> * Other names: RFA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Estimate the adverse event rate due to RFA within 1 month follow-up period. | 1 month post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | pain intensity as measured by VASPI Scale | 1 month post-procedure | 
| Pain intensity | pain intensity as measured by VASPI Scale | 3 months post-procedure | 
| Pain reduction | pain reduction as measured by VASPR Scale | 1 month post-procedure | 
| Pain reduction | pain reduction as measured by VASPR Scale | 3 month post-procedure | 
| Mood | Mood as measured byt the VASMOOD scale | 1 month post-procedure | 
| Mood | Mood as measured by the VASMOOD scale | 3 month post-procedure | 
| Pain Severity | Pain severity as measured by the Tursky scale | 1 month post-procedure | 
| Pain Severity | Pain severity as measured by the Tursky scale | 3 month post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone metastases, pain, unspecified adult solid tumor, protocol specific