Safety and Efficacy of Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone Metastases
Primary Purpose
Pain, Neoplasm Metastasis
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Cryoablation
Radiation
Sponsored by
About this trial
This is an interventional supportive care trial for Pain focused on measuring Painful bone metastases, Bone metastases, Metastatic bone tumors, Metastatic bone pain, Cryoablation, Cryotherapy, Cryosurgery, Radiation therapy, Radiotherapy
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- Metastatic bone disease with metastatic disease previously confirmed by prior biopsy; or Metastatic bone disease previously confirmed on imaging [e.g. computed tomography (CT) or magnetic resonance imaging (MRI)] with known (biopsied) primary disease (primary bone cancer is excluded)
- Current analgesic therapies have failed OR the subject is experiencing intolerable side effects
- Unremitting pain that resulted in a return visit to the oncologist. The 'worst pain' in the last 24 hours must be reported to be 4 or above on a scale of 0 (no pain) to 10 (pain as bad as subject can imagine) despite pharmaceutical pain management
Pain must be from one or two painful metastatic sites in the bone that is amenable to cryoablation with CT or MRI (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, MRI, or ultrasound (US) imaging
- Tumors must be suitable for cryoablation
- If the primary tumor is in the spine, there must be an intact cortex between the mass and the spinal canal and exiting nerve roots
- Cryoablation should be performed within 14 days of baseline evaluations
- Stable use of hormonal therapy (no changes within 4 weeks prior to the cryoablation procedure)
- Stable use of pain medications (no changes within 2 weeks prior to the cryoablation procedure)
- ECOG (Eastern Cooperative Oncology Group) scale performance status 0-3
- Life expectancy ≥ 2 months
- Platelet count >50,000/mm³ within 6 weeks of screening
- INR (International Normalized Ratio) <1.5 within 6 weeks of screening
- No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
- If taking antiplatelet or anticoagulation medication, it must be able to be discontinued prior to the procedure for an appropriate amount of time (e.g., aspirin, ibuprofen, low molecular weight heparin preparations)
- Clinically suitable for cryoablation therapy
- Clinically suitable for radiation therapy
Exclusion Criteria:
- Leukemia, lymphoma, and myeloma
- Tumor involves a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone
- Has undergone prior ablation treatment of the index tumor
- Has undergone prior radiation therapy of the index tumor < 3 weeks prior to screening
- Index tumor causing clinical or radiographic evidence of spinal cord or cauda equina 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, bowel, or bladder
- Surgery at the tumor site or surgery involving the cryoablation-treated tumor
- Index tumor involves the skull (treatment of other painful tumors in subjects with skull tumors is not excluded)
- ANC (absolute neutrophil count) <1000 mm3 within 6 weeks of screening
- Uncontrolled coagulopathy or bleeding disorders
- Currently pregnant, nursing, or wishing to become pregnant during the study
- Active, uncontrolled infection
- Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to study entry
- Concurrent participation in other experimental studies that could affect the primary endpoint
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cryoablation combined with radiation
Arm Description
All subjects will have cryoablation combined with radiation on one or two painful metastatic bone tumors.
Outcomes
Primary Outcome Measures
Difference in worst pain scores
The endpoint for this study will be measured as follows: assessment of the effectiveness of cryoablation combined with radiation associated with palliation of pain in subjects with metastatic bone cancer by measuring the average difference of pre- and posttreatment worst pain in 24 hours from baseline to 24 hour, 1, 4, 12, and 24 week follow-up intervals as measured on the numeric 0 to 10 Brief Pain Inventory (BPI) scale.
Secondary Outcome Measures
Cryoablation retreatments
If the first cryoablation procedure effectively relieves pain but the relief wears off over time and the pain becomes unbearable, a second procedure may be performed. The number of repeat cryoablation treatments will be recorded.
Additional surgical treatments other than cryoablation
If pain is not effectively relieved by the cryoablation, other surgical treatments may be performed. The number of these treatments will be recorded.
Reduced analgesic usage
The number of subjects (percentage) who are able to reduce analgesic medications from baseline to 24 hours, 1, 4, 12, and 24 weeks after cryoablation will be recorded.
Time to maximal palliation of pain after cryoablation
The difference in pain scores will be assessed from baseline to follow-up intervals after cryoablation will be analyzed. The interval indicating the most relief from pain will be compared across subjects.
Number of adverse events
The safety endpoint for this study is to assess the incidence and severity of intra-operative events, post operative adverse events, serious adverse events and unanticipated adverse device effects related to the cryoablation procedure.
Difference in average pain scores
Difference in average pain scores from baseline to 24 hours, 1, 4, 12, and 24 weeks after cryoablation as measured on the numeric 0 to 10 BPI scale
Time to recurrence of worst pain
Time to recurrence of worst pain at or above baseline; worst pain score in the 24 week follow-up period as measured on the numeric 0 to 10 BPI scale
Subject satisfaction with the amount of palliation of pain obtained from cryoablation combined with radiation
Subject satisfaction will be compared at baseline to follow-up intervals.
Full Information
NCT ID
NCT01461252
First Posted
October 25, 2011
Last Updated
July 15, 2021
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01461252
Brief Title
Safety and Efficacy of Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone Metastases
Official Title
Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Why Stopped
No patients were treated due to enrollment challenges.
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the safety and efficacy of cryoablation therapy combined with radiation therapy for the relief of pain associated with metastatic bone tumors.
Detailed Description
Patients with painful bone metastases who meet the eligibility criteria and who have been determined to be an appropriate candidate for cryoablation therapy and radiation therapy will be offered enrollment into the study. Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal) and urology (kidney). Radiation therapy, also called radiotherapy, uses carefully targeted doses of high-energy radiation to kill cancer cells. Radiation is used to treat many kinds of cancer.
Patients agreeing to participate will read and sign an informed consent form and thus become subjects in the study. Treatment will be performed using a Galil Medical cryoablation system and Galil Medical cryoablation needles. Subjects will be followed for up to 24 weeks (6 months) for palliation of pain, quality of life and analgesic usage. Baseline and follow-up data will be collected for each subject via a web-based electronic data collection tool.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Neoplasm Metastasis
Keywords
Painful bone metastases, Bone metastases, Metastatic bone tumors, Metastatic bone pain, Cryoablation, Cryotherapy, Cryosurgery, Radiation therapy, Radiotherapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cryoablation combined with radiation
Arm Type
Other
Arm Description
All subjects will have cryoablation combined with radiation on one or two painful metastatic bone tumors.
Intervention Type
Procedure
Intervention Name(s)
Cryoablation
Other Intervention Name(s)
Cryotherapy, Cryosurgery, Visual-ICE Cryoabltaion System, SeedNet Cryoablation System, PresIce Cryoablation System, IceRod Cryoablation Needle, IceRod PLUS Cryoablation Needle, IceEDGE 2.4 Cryoablation Needle, IceSeed Cryoablation Needle, IceSphere Cryoablation Needle
Intervention Description
For cryoablation in the palliation of painful bone metastases, subject preparation, anesthesia, intra-operative monitoring, and postoperative management are identical to those of standard cryoablation routinely performed at all clinical centers participating in this study and are at the discretion of the investigator.
Intervention Type
Procedure
Intervention Name(s)
Radiation
Other Intervention Name(s)
Radiotherapy
Intervention Description
Radiation therapy is usually performed with 6-18 Megavolt photons from a linear accelerator. The proposed dose and frequency of radiation for this protocol are: 8 Gray in 1 fraction, 30 Gray in 10 fractions, or 37.5 Gray in 15 fractions. These proposed doses or other doses will be prescribed at the discretion of the investigator. It is anticipated that subjects will begin the radiation therapy approximately within one to three weeks after the cryoablation procedure. The doses and frequency of the radiation treatment will be collected as well as toxicities.
Primary Outcome Measure Information:
Title
Difference in worst pain scores
Description
The endpoint for this study will be measured as follows: assessment of the effectiveness of cryoablation combined with radiation associated with palliation of pain in subjects with metastatic bone cancer by measuring the average difference of pre- and posttreatment worst pain in 24 hours from baseline to 24 hour, 1, 4, 12, and 24 week follow-up intervals as measured on the numeric 0 to 10 Brief Pain Inventory (BPI) scale.
Time Frame
24 weeks post cryoablation
Secondary Outcome Measure Information:
Title
Cryoablation retreatments
Description
If the first cryoablation procedure effectively relieves pain but the relief wears off over time and the pain becomes unbearable, a second procedure may be performed. The number of repeat cryoablation treatments will be recorded.
Time Frame
24 weeks post-cryoablation
Title
Additional surgical treatments other than cryoablation
Description
If pain is not effectively relieved by the cryoablation, other surgical treatments may be performed. The number of these treatments will be recorded.
Time Frame
24 weeks post-cryoablation
Title
Reduced analgesic usage
Description
The number of subjects (percentage) who are able to reduce analgesic medications from baseline to 24 hours, 1, 4, 12, and 24 weeks after cryoablation will be recorded.
Time Frame
24 weeks post-cryoablation
Title
Time to maximal palliation of pain after cryoablation
Description
The difference in pain scores will be assessed from baseline to follow-up intervals after cryoablation will be analyzed. The interval indicating the most relief from pain will be compared across subjects.
Time Frame
24 weeks post-cryoablation
Title
Number of adverse events
Description
The safety endpoint for this study is to assess the incidence and severity of intra-operative events, post operative adverse events, serious adverse events and unanticipated adverse device effects related to the cryoablation procedure.
Time Frame
30 days post-cryoablation
Title
Difference in average pain scores
Description
Difference in average pain scores from baseline to 24 hours, 1, 4, 12, and 24 weeks after cryoablation as measured on the numeric 0 to 10 BPI scale
Time Frame
24 weeks post-cryoablation
Title
Time to recurrence of worst pain
Description
Time to recurrence of worst pain at or above baseline; worst pain score in the 24 week follow-up period as measured on the numeric 0 to 10 BPI scale
Time Frame
24 weeks post-cryoablation
Title
Subject satisfaction with the amount of palliation of pain obtained from cryoablation combined with radiation
Description
Subject satisfaction will be compared at baseline to follow-up intervals.
Time Frame
24 weeks post-cryoablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
Metastatic bone disease with metastatic disease previously confirmed by prior biopsy; or Metastatic bone disease previously confirmed on imaging [e.g. computed tomography (CT) or magnetic resonance imaging (MRI)] with known (biopsied) primary disease (primary bone cancer is excluded)
Current analgesic therapies have failed OR the subject is experiencing intolerable side effects
Unremitting pain that resulted in a return visit to the oncologist. The 'worst pain' in the last 24 hours must be reported to be 4 or above on a scale of 0 (no pain) to 10 (pain as bad as subject can imagine) despite pharmaceutical pain management
Pain must be from one or two painful metastatic sites in the bone that is amenable to cryoablation with CT or MRI (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, MRI, or ultrasound (US) imaging
Tumors must be suitable for cryoablation
If the primary tumor is in the spine, there must be an intact cortex between the mass and the spinal canal and exiting nerve roots
Cryoablation should be performed within 14 days of baseline evaluations
Stable use of hormonal therapy (no changes within 4 weeks prior to the cryoablation procedure)
Stable use of pain medications (no changes within 2 weeks prior to the cryoablation procedure)
ECOG (Eastern Cooperative Oncology Group) scale performance status 0-3
Life expectancy ≥ 2 months
Platelet count >50,000/mm³ within 6 weeks of screening
INR (International Normalized Ratio) <1.5 within 6 weeks of screening
No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
If taking antiplatelet or anticoagulation medication, it must be able to be discontinued prior to the procedure for an appropriate amount of time (e.g., aspirin, ibuprofen, low molecular weight heparin preparations)
Clinically suitable for cryoablation therapy
Clinically suitable for radiation therapy
Exclusion Criteria:
Leukemia, lymphoma, and myeloma
Tumor involves a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone
Has undergone prior ablation treatment of the index tumor
Has undergone prior radiation therapy of the index tumor < 3 weeks prior to screening
Index tumor causing clinical or radiographic evidence of spinal cord or cauda equina 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, bowel, or bladder
Surgery at the tumor site or surgery involving the cryoablation-treated tumor
Index tumor involves the skull (treatment of other painful tumors in subjects with skull tumors is not excluded)
ANC (absolute neutrophil count) <1000 mm3 within 6 weeks of screening
Uncontrolled coagulopathy or bleeding disorders
Currently pregnant, nursing, or wishing to become pregnant during the study
Active, uncontrolled infection
Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to study entry
Concurrent participation in other experimental studies that could affect the primary endpoint
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry Matteo, MD
Organizational Affiliation
Shands Medical Center, Jacksonville, FL
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
18070690
Citation
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Safety and Efficacy of Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone Metastases
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