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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01325753
Recruitment Status : Withdrawn
First Posted : March 30, 2011
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE March 28, 2011
First Posted Date  ICMJE March 30, 2011
Last Update Posted Date July 3, 2018
Study Start Date  ICMJE March 2011
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2011)
Safety of interventional cryoablation to the lung [ Time Frame: 6 months ]
Unexpected toxiticities or Grade 4 or 5 toxicities will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2012)
  • Local control measured by imaging [ Time Frame: At 1 year ]
    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 [ Time Frame: approximately 60 months ]
    Measured by ECOG and KPS performance status, the Short Form - 12v2 questionnarie and shory physical performance battery
  • Changes in pulmonary function [ Time Frame: At 3 months ]
    Measure by pulmonary function test
  • Obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial [ Time Frame: approximately 60 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2011)
  • Local control measured by imaging [ Time Frame: At 1 year ]
    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)
  • Physical function and quality of life [ Time Frame: At baseline and 1, 3, 6, 12, 24, 36, 48, and 60 months ]
    Measured by ECOG and KPS performance status, the Short Form - 12v2 questionnarie and shory physical performance battery
  • Changes in pulmonary function [ Time Frame: At 3 months ]
    Measure by pulmonary function test
  • Obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial [ Time Frame: At 1 week and 1, 3, 6, 12, 24, 36, 48, and 60 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body
Official Title  ICMJE A Pilot Study of Cryoablation for Patients With Oligometastatic Cancer Involving the Lung
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Procedure: cryotherapy
    Undergo CT-guided CA
  • Procedure: quality-of-life assessment
    Ancillary studies
    Other Name: quality of life assessment
Study Arms  ICMJE Experimental: Treatment (cryoablation)
Patients undergo CT-guided CA.
Interventions:
  • Procedure: cryotherapy
  • Procedure: quality-of-life assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 16, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2011)
16
Estimated Study Completion Date  ICMJE March 2017
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01325753
Other Study ID Numbers  ICMJE IRB00015085
NCI-2011-00319 ( Registry Identifier: CTRP )
CCCWFU 62210 ( Other Identifier: Wake Forest University Health Sciences )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Urbanic Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP