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Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery

Primary Purpose

Lung Cancer, Metastatic Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cryosurgery
positron emission tomography
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring lung metastases, recurrent non-small cell lung cancer, recurrent small cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, extensive stage small cell lung cancer, limited stage small cell lung cancer, pulmonary carcinoid tumor

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed malignant pulmonary neoplasm New lung lesion(s) with definitive clinical and imaging features of primary or metastatic disease allowed Imaging findings compatible with localized treatment failure after prior cryotherapy allowed Malignant pleural effusion allowed provided it is associated with a distinct measurable pulmonary mass amenable to cryotherapy Metastatic disease must meet all of the following criteria: Primary tumors have been resected or have been deemed controlled by other therapies No other widespread metastases evident (e.g., multiple hepatic or brain metastases) Each pulmonary mass must be amenable to CT-guided percutaneous cryotherapy approach No more than 5 targeted masses for study therapy Target mass defined as pulmonary, hilar, mediastinal, and/or chest wall mass > 1 cm, but < 10 cm in average diameter Unresectable disease by surgical consultation OR patient refused surgical options Nonenhanced and enhanced CT scan required within the past 6 weeks done at 4-5 mm increments with available soft tissue and mediastinal windows to assess size and extent of all thoracic tumors PET scan required within the past 6 months noting the correlation with the above CT locations, if not already obtained by a combined PET/CT scanner PATIENT CHARACTERISTICS: Karnofsky performance status (PS) > 60-100% OR WHO/ECOG/Zubrod PS 0-2 FEV_1 > 30% of predicted DLCO > 40% of predicted Platelet count ≥ 70,000/mm^3 INR < 1.5 No uncontrolled coagulopathy or bleeding diathesis Not pregnant or nursing Negative pregnancy test No 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 No medical contraindication or potential problem that would preclude study compliance PRIOR CONCURRENT THERAPY: At least 7 days since prior aspirin and aspirin-like medications At least 3 days since prior warfarin, clopidogrel bisulfate, or similar compounds No concurrent drugs causing bleeding tendencies (e.g., aspirin, warfarin, or clopidogrel bisulfate) No concurrent participation in other experimental studies

Sites / Locations

  • Barbara Ann Karmanos Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cryosurgery

Arm Description

cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.

Outcomes

Primary Outcome Measures

Local Failure Rates by CT Scan
Local Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
Distant Failure Rate
Distant Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence

Secondary Outcome Measures

Rate of Complications and Adverse Reactions by Occurrences of Toxicities
Rate of complications and adverse reactions by occurrences of toxicities as measured by the number of participants with a given category of toxicity.
Correlate Procedural Parameters and Follow-up Imaging Parameters
Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures

Full Information

First Posted
March 15, 2006
Last Updated
July 7, 2020
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00303901
Brief Title
Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery
Official Title
Percutaneous Thoracic Cryotherapy (PTC) for Inoperable Primary Lung Cancer and Metastatic Management
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Cryotherapy kills tumor cells by freezing them. This may be an effective treatment for primary lung cancer or lung metastases that cannot be removed by surgery. PURPOSE: This clinical trial is studying how well cryotherapy works in treating patients with primary lung cancer or lung metastases that cannot be removed by surgery.
Detailed Description
OBJECTIVES: Estimate the local and distant failure rates after percutaneous thoracic cryotherapy (PTC) in patients with unresectable primary lung cancer or lung metastases. Estimate rates of PTC complications and adverse reactions. Determine the correlations between procedural parameters and follow-up imaging parameters, with the latter being used as surrogates of local and/or distant treatment failure. OUTLINE: Patients undergo CT-guided percutaneous thoracic cryotherapy over 2 hours under local or general anesthesia. Grouped cryoprobes are inserted into the tumor, utilizing a freeze-thaw-freeze cycle, creating cytotoxic temperatures (less than -20°C to -40°C) that encompass the entire anticipated tumor volume. Patients undergo positron emission tomography at baseline and after cryotherapy to assess tumor standard uptake variable. After completion of study treatment, patients are followed at 1, 3, 6 and 12 months. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Metastatic Cancer
Keywords
lung metastases, recurrent non-small cell lung cancer, recurrent small cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, extensive stage small cell lung cancer, limited stage small cell lung cancer, pulmonary carcinoid tumor

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
cryosurgery
Arm Type
Experimental
Arm Description
cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.
Intervention Type
Procedure
Intervention Name(s)
cryosurgery
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography
Primary Outcome Measure Information:
Title
Local Failure Rates by CT Scan
Description
Local Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
Time Frame
at 3, 6, and 12 months
Title
Distant Failure Rate
Description
Distant Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
Time Frame
at 3, 6, and 12 months
Secondary Outcome Measure Information:
Title
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
Description
Rate of complications and adverse reactions by occurrences of toxicities as measured by the number of participants with a given category of toxicity.
Time Frame
at 3, 6, and 12 months
Title
Correlate Procedural Parameters and Follow-up Imaging Parameters
Time Frame
at 3, 6, and 12 months
Title
Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures
Time Frame
12 months after the last patient was enrolled

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed malignant pulmonary neoplasm New lung lesion(s) with definitive clinical and imaging features of primary or metastatic disease allowed Imaging findings compatible with localized treatment failure after prior cryotherapy allowed Malignant pleural effusion allowed provided it is associated with a distinct measurable pulmonary mass amenable to cryotherapy Metastatic disease must meet all of the following criteria: Primary tumors have been resected or have been deemed controlled by other therapies No other widespread metastases evident (e.g., multiple hepatic or brain metastases) Each pulmonary mass must be amenable to CT-guided percutaneous cryotherapy approach No more than 5 targeted masses for study therapy Target mass defined as pulmonary, hilar, mediastinal, and/or chest wall mass > 1 cm, but < 10 cm in average diameter Unresectable disease by surgical consultation OR patient refused surgical options Nonenhanced and enhanced CT scan required within the past 6 weeks done at 4-5 mm increments with available soft tissue and mediastinal windows to assess size and extent of all thoracic tumors PET scan required within the past 6 months noting the correlation with the above CT locations, if not already obtained by a combined PET/CT scanner PATIENT CHARACTERISTICS: Karnofsky performance status (PS) > 60-100% OR WHO/ECOG/Zubrod PS 0-2 FEV_1 > 30% of predicted DLCO > 40% of predicted Platelet count ≥ 70,000/mm^3 INR < 1.5 No uncontrolled coagulopathy or bleeding diathesis Not pregnant or nursing Negative pregnancy test No 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 No medical contraindication or potential problem that would preclude study compliance PRIOR CONCURRENT THERAPY: At least 7 days since prior aspirin and aspirin-like medications At least 3 days since prior warfarin, clopidogrel bisulfate, or similar compounds No concurrent drugs causing bleeding tendencies (e.g., aspirin, warfarin, or clopidogrel bisulfate) No concurrent participation in other experimental studies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J. Littrup, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States

12. IPD Sharing Statement

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Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery

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