Cryosurgery and Radiation Therapy in Treating Patients With Painful Bone Metastases

Study Overview
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Brief Summary
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This pilot clinical trial studies cryosurgery and radiation therapy in treating patients with painful bone metastases. Cryosurgery kills tumor cells by freezing them. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Giving cryosurgery together with radiation therapy may kill more tumor cells

Detailed Description
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PRIMARY OBJECTIVES: I. To assess the potential for efficacy and safety of combining percutaneous computed tomography (CT)-guided cryoablation and radiotherapy for the palliation of osseous metastases. OUTLINE: Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 24 hours and weeks 1-2, 4, 12, 18, and 24.

Official Title
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A Pilot Study of The Tandem Treatment of Painful Osseous Metastases With Cryoablation Followed by Radiation Therapy

Conditions
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Bone Metastases, Pain

Intervention / Treatment
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* Procedure: cryosurgery
* Radiation: radiation therapy
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically (histologically or cytologically) confirmed metastatic disease with a new tumor involving or abutting bone that has the clinical and imaging features of metastatic disease If the nature of the metastatic disease has been previously documented, index tumor to be treated does not require further documentation (i.e., biopsy) Current analgesic therapies have failed (worst pain of 4 or above as measured by Brief Pain Inventory [BPI], despite analgesic therapy) OR the subject is experiencing intolerable side effects that preclude analgesic use (resulting in pain of 4 or above, as measured by BPI) Pain must be from one or two painful metastatic sites in the bone (additional less painful metastatic sites may be present) Pain from the reported one or two metastatic sites must correlate with an identifiable tumor on CT, magnetic resonance imaging (MRI), or ultrasound (US) imaging Metastatic tumors must be amenable to cryoablation with CT or MRI If the index tumor is in the spine, there must be an intact cortex between the mass and the spinal canal and exiting nerve roots Patients must have stable use of hormonal therapy for two weeks prior to study registration and two weeks prior to cryoablation procedure) Stable use of pain medications (no changes within two weeks of cryoablation procedure) Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Life expectancy >= 2 months Platelets > 50,000/mm^3 International normalized ratio (INR) >= 1.5 Patients may not have any debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up Patients who are taking antiplatelet or anticoagulation medication (e.g., aspirin, ibuprofen, low molecular weight heparin [LMWH] preparations) must be able to discontinue such treatment prior to the cryoablation procedure for an appropriate amount of time; at least 5 days should be allowed after discontinuation of aspirin, Coumadin, clopidogrel, and dipyridamole; at least 12 hours should be allowed after discontinuation of LMWH preparations Patients must be clinically suitable for cryoablation therapy Patients must be clinically suitable for radiation therapy Patients must be able to understand and willing to sign a written informed consent document Exclusion Criteria: Patients with a diagnosis of leukemia, lymphoma, or myeloma Patients with a tumor involving a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone Patients who have undergone prior ablation treatment or radiation therapy of the index tumor Patients who have received chemotherapy within 14 days prior to and 14 days after cryoablation procedure Index tumor(s) causing clinical or radiographic evidence of spinal cord or cauda equine compression/effacement Anticipated treatment of the index tumor that would require iceball formation within 1.0 cm of the spinal cord, brain, other critical nerve structure, large abdominal vessel such as the aorta or inferior vena cava (IVC), bowel, or bladder Any prior surgery at the proposed treatment site OR any prior surgery involving the cryoablation-treated tumor Index tumor involves the skull (treatment of other painful tumors in subjects with skull tumors is not excluded) Patients with uncontrolled coagulopathy or bleeding disorders Patients who are pregnant, nursing, or who wish to become pregnant during the study Patients with active, uncontrolled infection Patients with serious medical illnesses, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within six months prior to study entry Patients who are concurrently participating in any other experimental studies that could affect the primary endpoint of this study

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (cryosurgery and radiation therapy)<br>Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. | Procedure: cryosurgery<br>* Undergo cryosurgery<br>* Other names: cryosurgical ablation;Radiation: radiation therapy<br>* Undergo radiation therapy<br>* Other names: therapy, radiation;Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Level at 24 Hours Before Cryosurgery, as Measured by the BPI | Numerical scores (0-10) from the BPI will be used to measure pain levels. Higher scores denotes worse outcome. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Medication Level, Assessed by Changes in Narcotic Medication Usage | Pain medication assessments will be used to quantify any change in narcotic medication usage using the 24-hour morphine equivalent dose. | Baseline to 24 weeks | 
| Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |  | Up to 24 weeks | 
| Pain After Cryosurgery, as Measured by the BPI | Questions #4 (least pain), #5 (average pain), and #6 (right now) from the BPI (reported on 0-10 scale) will be used as the secondary outcome measures. Higher scores denotes worse outcome | Up to 24 weeks | 
| Number of Participants Who Survived | Count of participants that survived. | Up to 24 weeks post-cryosurgery |