Cryosurgery and Radiation Therapy in Treating Patients With Painful Bone Metastases

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

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

Study Overview

• Status: Terminated
• Conditions: Pain; Bone Metastases
• Intervention / Treatment: Procedure: quality-of-life assessment; Radiation: radiation therapy; Procedure: cryosurgery

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Radiation: radiation therapy; Undergo radiation therapy; Other Names: irradiation; radiotherapy; therapy, radiation; Procedure: cryosurgery; Undergo cryosurgery; Other Names: cryoablation; cryosurgical ablation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI); Endocare, Inc.
• Investigators: Principal Investigator: David Childs, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 11, 2013
• First Submitted That Met QC Criteria: January 11, 2013
• First Posted (Estimate): January 15, 2013

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: October 17, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: IRB00020528; P30CA012197 (U.S. NIH Grant/Contract); NCI-2012-02087 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CCCWFU 97212 (Other Identifier: Wake Forest University Health Sciences)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes