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

18 Years
Not Enrolling
Bone Metastases, Pain

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Trial Information

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


I. To assess the potential for efficacy and safety of combining percutaneous computed
tomography (CT)-guided cryoablation and radiotherapy for the palliation of osseous


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.

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)

- 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

- 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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Changes in pain level, as measured by the BPI

Outcome Description:

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.

Outcome Time Frame:

Baseline to 24 weeks

Safety Issue:


Principal Investigator

David Childs

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Institutional Review Board

Study ID:

CCCWFU 97212



Start Date:

December 2012

Completion Date:

Related Keywords:

  • Bone Metastases
  • Pain
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Bone Neoplasms
  • Bone Marrow Diseases



Comprehensive Cancer Center of Wake Forest UniversityWinston-Salem, North Carolina  27157-1082