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Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body

Primary Purpose

Advanced Malignant Mesothelioma, Extensive Stage Small Cell Lung Cancer, Lung Metastases

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cryotherapy
quality-of-life assessment
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Malignant Mesothelioma

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with American Joint Committee on Cancer (AJCC) seventh edition metastatic carcinoma or sarcoma involving the lungs or pleura.
  • Pathologic diagnosis of stage 4 cancer prior to enrollment by biopsy or on imaging with known (biopsied) primary disease
  • The target lesion is determined (by CT or magnetic resonance imaging [MRI] images) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs and structures
  • Maximum number of lesions per patient will be 5 total (a maximum of 3 on either the right or left side and 2 lesions on the respective contralateral side)
  • Of these, any lesion not treated with cryoablation will be planned to be treated with radiotherapy or radiofrequency ablation, such that all known active pulmonary disease is planned to be treated with a definitive local therapy
  • If treatment of both lungs is to occur by cryoablation, these treatments must be separated by at least one week
  • The lesion(s) treated with cryoablation may be intrapulmonary or pleural and must be =< 3.5 cm in greatest dimension
  • All patients are required to have been evaluated either in consultation with a radiation oncologist or at least in a multi-disciplinary tumor conference to ensure that all local therapy options are appropriately considered for each patient
  • Performance Status 0-2 (Eastern Cooperative Oncology Group [ECOG]); Karnofsky Performance Scale >= 60
  • Life expectancy > 3 months
  • Clinically suitable for cryoablation procedure as determined by the treating physician
  • Platelet count > 50,000/mm^3 within 60 days prior to study registration
  • International normalized ratio (INR) < 1.5 within 60 days prior to study registration
  • Absolute neutrophil count (ANC) < 1000 within 21 days prior to study registration
  • A signed study specific consent form is required

Exclusion Criteria:

  • Primary lung cancer
  • Unable to lie flat or has respiratory distress at rest
  • Uncontrolled coagulopathy or bleeding disorders
  • Evidence of active systemic, pulmonary, or pericardial infection
  • Pregnant, nursing or wishes to become pregnant during the study
  • Debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up
  • Currently participating in other experimental studies that could affect the primary endpoint

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment (cryoablation)

    Arm Description

    Patients undergo CT-guided CA.

    Outcomes

    Primary Outcome Measures

    Safety of interventional cryoablation to the lung
    Unexpected toxiticities or Grade 4 or 5 toxicities will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).

    Secondary Outcome Measures

    Local control measured by imaging
    Measure definitions: Complete Response(tumor disappearance or less than 25% of original size) Partial Response (greater than 30% decrease in the sum of the largest diameter of all targeted tumors) stable Disease (less than 30% decrease in the sum of the largest diameter of all targeted tumors) Local Failure (greater than 20% increase in the sum of the largest diameter of all targeted tumors) Distant Failure (the appearance of distant cancer deposits consistent with metastatic spread of cancer outside the intended treatment area)
    Changes in Physical function and quality of life
    Measured by ECOG and KPS performance status, the Short Form - 12v2 questionnarie and shory physical performance battery
    Changes in pulmonary function
    Measure by pulmonary function test
    Obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial

    Full Information

    First Posted
    March 28, 2011
    Last Updated
    July 2, 2018
    Sponsor
    Wake Forest University Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01325753
    Brief Title
    Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body
    Official Title
    A Pilot Study of Cryoablation for Patients With Oligometastatic Cancer Involving the Lung
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    March 2013 (Anticipated)
    Study Completion Date
    March 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wake Forest University Health Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This pilot clinical trial studies the side effects of cryotherapy (cryoablation [CA]) in treating patients with lung cancer. Cryotherapy kills cancer cells by freezing them.
    Detailed Description
    PRIMARY OBJECTIVES: I. Assess the initial safety of the CA for lung tumors less than or equal to 3.5 cm in size including acute toxicity (30 days). SECONDARY OBJECTIVES: I. Estimate local control. II. To assess physical function for this cohort of patients. III. To evaluate the impact of treatment on generic and disease-specific quality of life. IV. To obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial. V. Evaluate changes in pulmonary function at 3 months. OUTLINE: Patients undergo computed tomography (CT)-guided CA After completion of study treatment, patients are followed up at 1 week and 1, 3, 6, 12, 24, 36, 48, and 60 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced Malignant Mesothelioma, Extensive Stage Small Cell Lung Cancer, Lung Metastases, Recurrent Malignant Mesothelioma, Recurrent Non-small Cell Lung Cancer, Recurrent Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment (cryoablation)
    Arm Type
    Experimental
    Arm Description
    Patients undergo CT-guided CA.
    Intervention Type
    Procedure
    Intervention Name(s)
    cryotherapy
    Intervention Description
    Undergo CT-guided CA
    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
    Safety of interventional cryoablation to the lung
    Description
    Unexpected toxiticities or Grade 4 or 5 toxicities will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Local control measured by imaging
    Description
    Measure definitions: Complete Response(tumor disappearance or less than 25% of original size) Partial Response (greater than 30% decrease in the sum of the largest diameter of all targeted tumors) stable Disease (less than 30% decrease in the sum of the largest diameter of all targeted tumors) Local Failure (greater than 20% increase in the sum of the largest diameter of all targeted tumors) Distant Failure (the appearance of distant cancer deposits consistent with metastatic spread of cancer outside the intended treatment area)
    Time Frame
    At 1 year
    Title
    Changes in Physical function and quality of life
    Description
    Measured by ECOG and KPS performance status, the Short Form - 12v2 questionnarie and shory physical performance battery
    Time Frame
    approximately 60 months
    Title
    Changes in pulmonary function
    Description
    Measure by pulmonary function test
    Time Frame
    At 3 months
    Title
    Obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial
    Time Frame
    approximately 60 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with American Joint Committee on Cancer (AJCC) seventh edition metastatic carcinoma or sarcoma involving the lungs or pleura. Pathologic diagnosis of stage 4 cancer prior to enrollment by biopsy or on imaging with known (biopsied) primary disease The target lesion is determined (by CT or magnetic resonance imaging [MRI] images) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs and structures Maximum number of lesions per patient will be 5 total (a maximum of 3 on either the right or left side and 2 lesions on the respective contralateral side) Of these, any lesion not treated with cryoablation will be planned to be treated with radiotherapy or radiofrequency ablation, such that all known active pulmonary disease is planned to be treated with a definitive local therapy If treatment of both lungs is to occur by cryoablation, these treatments must be separated by at least one week The lesion(s) treated with cryoablation may be intrapulmonary or pleural and must be =< 3.5 cm in greatest dimension All patients are required to have been evaluated either in consultation with a radiation oncologist or at least in a multi-disciplinary tumor conference to ensure that all local therapy options are appropriately considered for each patient Performance Status 0-2 (Eastern Cooperative Oncology Group [ECOG]); Karnofsky Performance Scale >= 60 Life expectancy > 3 months Clinically suitable for cryoablation procedure as determined by the treating physician Platelet count > 50,000/mm^3 within 60 days prior to study registration International normalized ratio (INR) < 1.5 within 60 days prior to study registration Absolute neutrophil count (ANC) < 1000 within 21 days prior to study registration A signed study specific consent form is required Exclusion Criteria: Primary lung cancer Unable to lie flat or has respiratory distress at rest Uncontrolled coagulopathy or bleeding disorders Evidence of active systemic, pulmonary, or pericardial infection Pregnant, nursing or wishes to become pregnant during the study Debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up Currently participating in other experimental studies that could affect the primary endpoint
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    James Urbanic
    Organizational Affiliation
    Wake Forest University Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body

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