Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery
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.
Procedure: positron emission tomography
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Percutaneous Thoracic Cryotherapy (PTC) for Inoperable Primary Lung Cancer and Metastatic Management|
- Local and distant failure rates by CT scan [ Time Frame: at 3, 6, and 12 months ] [ Designated as safety issue: No ]
- Rate of complications and adverse reactions by occurrences of toxicities [ Time Frame: at 3, 6, and 12 months ] [ Designated as safety issue: Yes ]
- Correlate procedural parameters and follow-up imaging parameters [ Time Frame: at 3, 6, and 12 months ] [ Designated as safety issue: No ]
- Point and exact confidence interval estimates of patients who undergo multiple cryotherapy procedures [ Time Frame: 12 months after the last patient was enrolled ] [ Designated as safety issue: No ]
|Study Start Date:||November 2005|
|Estimated Study Completion Date:||November 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
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.
|Procedure: cryosurgery Procedure: positron emission tomography|
- 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.
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Study Chair:||Peter J. Littrup, MD||Barbara Ann Karmanos Cancer Institute|