Percutaneous Thoracic Cryotherapy (PTC) for Inoperable Primary Lung Cancer and Metastatic Management
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Barbara Ann Karmanos Cancer Institute
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Local Failure Rates by CT Scan
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Peter John Littrup
Principal Investigator
Barbara Ann Karmanos Cancer Institute
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Local Failure Rates by CT Scan
Time Frame: at 3, 6, and 12 months
Local Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
Distant Failure Rate
Time Frame: at 3, 6, and 12 months
Distant Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
Secondary Outcomes
- Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures(12 months after the last patient was enrolled)
- Correlate Procedural Parameters and Follow-up Imaging Parameters(at 3, 6, and 12 months)
- Rate of Complications and Adverse Reactions by Occurrences of Toxicities(at 3, 6, and 12 months)