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

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ClinicalTrials.gov Identifier: NCT01325753
Recruitment Status : Withdrawn
First Posted : March 30, 2011
Last Update Posted : July 3, 2018
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
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 Procedure: cryotherapy Procedure: quality-of-life assessment Not Applicable

Detailed Description:


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).


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.


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Cryoablation for Patients With Oligometastatic Cancer Involving the Lung
Study Start Date : March 2011
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2017

Arm Intervention/treatment
Experimental: Treatment (cryoablation)
Patients undergo CT-guided CA.
Procedure: cryotherapy
Undergo CT-guided CA

Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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)

  2. 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

  3. Changes in pulmonary function [ Time Frame: At 3 months ]
    Measure by pulmonary function test

  4. Obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial [ Time Frame: approximately 60 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325753

Sponsors and Collaborators
Wake Forest University Health Sciences
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Principal Investigator: James Urbanic Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01325753    
Other Study ID Numbers: IRB00015085
NCI-2011-00319 ( Registry Identifier: CTRP )
CCCWFU 62210 ( Other Identifier: Wake Forest University Health Sciences )
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Mesothelioma, Malignant
Disease Attributes
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Pleural Neoplasms