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Cryosurgery and Radiation Therapy in Treating Patients With Painful Bone Metastases

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ClinicalTrials.gov Identifier: NCT01767935
Recruitment Status : Terminated (Slow Accruals)
First Posted : January 15, 2013
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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

Condition or disease Intervention/treatment
Bone Metastases Pain Procedure: cryosurgery Radiation: radiation therapy Procedure: quality-of-life assessment

Detailed Description:


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.


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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of The Tandem Treatment of Painful Osseous Metastases With Cryoablation Followed by Radiation Therapy
Study Start Date : July 2014
Primary Completion Date : December 2014
Study Completion Date : December 2014
Arms and Interventions

Arm Intervention/treatment
Experimental: Treatment (cryosurgery and radiation therapy)
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
Undergo cryosurgery
Other Names:
  • cryoablation
  • cryosurgical ablation
Radiation: radiation therapy
Undergo radiation therapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Outcome Measures

Primary Outcome Measures :
  1. Changes in Pain Level, as Measured by the BPI [ Time Frame: Baseline to 24 weeks ]
    Numerical scores (0-10) from the BPI will be used to measure any change in pain levels. Paired t-tests will be used to assess changes.

Secondary Outcome Measures :
  1. Pain Medication Level, Assessed by Changes in Narcotic Medication Usage [ Time Frame: Baseline to 24 weeks ]
    Pain medication assessments will be used to quantify any change in narcotic medication usage using the 24-hour morphine equivalent dose. Paired t-tests and repeated measures analysis adjusting for ECOG status will be used.

  2. Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 [ Time Frame: Up to 24 weeks ]
  3. Pain Reduction After Cryosurgery, as Measured by the BPI [ Time Frame: Up to 2 weeks post-cryosurgery ]
    Paired t-tests and repeated measures analysis adjusting for ECOG status will be used.

  4. Survival [ Time Frame: Up to 24 weeks post-cryosurgery ]
    Kaplan-Meier curves will be generated.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767935

United States, North Carolina
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Endocare, Inc.
Principal Investigator: David Childs Wake Forest University Health Sciences
More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01767935     History of Changes
Other Study ID Numbers: CCCWFU 97212
NCI-2012-02087 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: January 15, 2013    Key Record Dates
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases