Cryosurgery and Radiation Therapy in Treating Patients With Painful Bone Metastases

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Collaborators:
Endocare, Inc.
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01767935
First received: January 11, 2013
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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 Intervention
Bone Metastases
Pain
Procedure: cryosurgery
Radiation: radiation therapy
Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of The Tandem Treatment of Painful Osseous Metastases With Cryoablation Followed by Radiation Therapy

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Changes in pain level, as measured by the BPI [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
    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:
  • Pain medication level, assessed by changes in narcotic medication usage [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
  • Pain reduction after cryosurgery, as measured by the BPI [ Time Frame: Up to 2 weeks post-cryosurgery ] [ Designated as safety issue: No ]
    Paired t-tests and repeated measures analysis adjusting for ECOG status will be used.

  • Survival [ Time Frame: Up to 24 weeks post-cryosurgery ] [ Designated as safety issue: No ]
    Kaplan-Meier curves will be generated.


Estimated Enrollment: 15
Study Start Date: July 2014
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767935

Locations
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: David Childs    336-716-2471    dchilds@wakehealth.edu   
Principal Investigator: David Childs         
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Endocare, Inc.
Investigators
Principal Investigator: David Childs Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01767935     History of Changes
Other Study ID Numbers: CCCWFU 97212, NCI-2012-02087, P30CA012197
Study First Received: January 11, 2013
Last Updated: July 18, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 21, 2014