Cryosurgery and Radiation Therapy in Treating Patients With Painful Bone Metastases
Primary Purpose
Bone Metastases, Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cryosurgery
radiation therapy
quality-of-life assessment
Sponsored by
About this trial
This is an interventional treatment trial for Bone Metastases
Eligibility 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
Sites / Locations
- Comprehensive Cancer Center of Wake Forest University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (cryosurgery and radiation therapy)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
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
Number of Participants Who Survived
Count of participants that survived.
Full Information
NCT ID
NCT01767935
First Posted
January 11, 2013
Last Updated
October 17, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI), Endocare, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01767935
Brief Title
Cryosurgery and Radiation Therapy in Treating Patients With Painful Bone Metastases
Official Title
A Pilot Study of The Tandem Treatment of Painful Osseous Metastases With Cryoablation Followed by Radiation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow Accruals
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI), Endocare, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Metastases, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (cryosurgery and radiation therapy)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
cryosurgery
Other Intervention Name(s)
cryoablation, cryosurgical ablation
Intervention Description
Undergo cryosurgery
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Other Intervention Name(s)
irradiation, radiotherapy, therapy, radiation
Intervention Description
Undergo radiation therapy
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Pain Level at 24 Hours Before Cryosurgery, as Measured by the BPI
Description
Numerical scores (0-10) from the BPI will be used to measure pain levels. Higher scores denotes worse outcome.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain Medication Level, Assessed by Changes in Narcotic Medication Usage
Description
Pain medication assessments will be used to quantify any change in narcotic medication usage using the 24-hour morphine equivalent dose.
Time Frame
Baseline to 24 weeks
Title
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
Title
Pain After Cryosurgery, as Measured by the BPI
Description
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
Time Frame
Up to 24 weeks
Title
Number of Participants Who Survived
Description
Count of participants that survived.
Time Frame
Up to 24 weeks post-cryosurgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Childs
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comprehensive Cancer Center of Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cryosurgery and Radiation Therapy in Treating Patients With Painful Bone Metastases
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