Safety and Efficacy of Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone Metastases

This study has been withdrawn prior to enrollment.
(No patients were treated due to enrollment challenges.)
Sponsor:
Information provided by (Responsible Party):
Galil Medical
ClinicalTrials.gov Identifier:
NCT01461252
First received: October 25, 2011
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Pain
Neoplasm Metastasis
Procedure: Cryoablation
Procedure: Radiation
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone Metastases

Resource links provided by NLM:


Further study details as provided by Galil Medical:

Primary Outcome Measures:
  • Difference in worst pain scores [ Time Frame: 24 weeks post cryoablation ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks post-cryoablation ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks post-cryoablation ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks post-cryoablation ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks post-cryoablation ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 days post-cryoablation ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 24 weeks post-cryoablation ] [ Designated as safety issue: No ]
    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 Frame: 24 weeks post-cryoablation ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks post-cryoablation ] [ Designated as safety issue: No ]
    Subject satisfaction will be compared at baseline to follow-up intervals.


Enrollment: 0
Study Start Date: April 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cryoablation combined with radiation
All subjects will have cryoablation combined with radiation on one or two painful metastatic bone tumors.
Procedure: Cryoablation
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.
Other Names:
  • 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
Procedure: Radiation
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.
Other Name: Radiotherapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01461252

Sponsors and Collaborators
Galil Medical
Investigators
Study Chair: Jerry Matteo, MD Shands Medical Center, Jacksonville, FL
  More Information

Publications:

Responsible Party: Galil Medical
ClinicalTrials.gov Identifier: NCT01461252     History of Changes
Other Study ID Numbers: CUC10-BNE01
Study First Received: October 25, 2011
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Galil Medical:
Painful bone metastases
Bone metastases
Metastatic bone tumors
Metastatic bone pain
Cryoablation
Cryotherapy
Cryosurgery
Radiation therapy
Radiotherapy

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014