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Withdrawn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
About this trial
This is an interventional treatment trial for Advanced Malignant Mesothelioma
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
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
NCT ID
NCT01325753
First Posted
March 28, 2011
Last Updated
July 2, 2018
Sponsor
Wake Forest University Health Sciences
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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