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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Withdrawn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
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 25, 2011
    Last Updated
    July 15, 2021
    Sponsor
    Boston Scientific Corporation
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    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

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    McQuay HJ, Collins SL, Carroll D, Moore RA. Radiotherapy for the palliation of painful bone metastases. Cochrane Database Syst Rev. 2000;(2):CD001793. doi: 10.1002/14651858.CD001793.
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    Chow E, Harris K, Fan G, Tsao M, Sze WM. Palliative radiotherapy trials for bone metastases: a systematic review. J Clin Oncol. 2007 Apr 10;25(11):1423-36. doi: 10.1200/JCO.2006.09.5281.
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    PubMed Identifier
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    Callstrom MR, Atwell TD, Charboneau JW, Farrell MA, Goetz MP, Rubin J, Sloan JA, Novotny PJ, Welch TJ, Maus TP, Wong GY, Brown KJ. Painful metastases involving bone: percutaneous image-guided cryoablation--prospective trial interim analysis. Radiology. 2006 Nov;241(2):572-80. doi: 10.1148/radiol.2412051247.
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    Coleman RE. Management of bone metastases. Oncologist. 2000;5(6):463-70. doi: 10.1634/theoncologist.5-6-463.
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    Safety and Efficacy of Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone Metastases

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