RATIONALE: Cryotherapy kills tumor cells by freezing them. Giving cryotherapy before surgery may kill more tumor cells. PURPOSE: This phase I trial is studying how well cryotherapy works in treating patients with primary stage I non-small cell lung cancer or lung metastasis.
OBJECTIVES: Primary * Evaluate the histologic result of treating patients with primary stage I non-small cell lung cancer or lung metastasis after neoadjuvant percutaneous cryotherapy (PTC). Secondary * Provide a qualitative assessment of the histology from the ablation and tumor margins, comparing histologic observations with imaging-enhancement patterns by CT or PET scan before and after PTC. OUTLINE: Patients undergo CT-guided percutaneous cryotherapy (PTC) over 2 hours. Approximately 3 weeks after completion of PTC, patients undergo thoracotomy consisting of lobectomy of the primary lung cancer or wedge resection with adequate margin for the metastatic lesion, and mediastinal lymph node dissection. Tissue samples from ablation and tumor margins are collected during thoracotomy and compared with imaging-enhanced patterns of CT or PET scans taken at baseline and after PTC. After completion of study therapy, patients are followed periodically for 6 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
CT-guided PTC with the intent to eradicate the entire tumor(s).
Prednisone taken: 20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
The Number of Patients With a Response (Complete Response and Partial Response)
Treatment success was defined as \> 75% of the resected ablated tissue showing no cancer on detailed histologic analysis. The primary statistical objective was to estimate the PCA success rate (p).
Time frame: 3 weeks post-Percutaneous Cryotherapy (PTC)
The Number of Patients With a Pathologic Response
Histology samples from anterior, posterior, superior, inferior, medial and lateral areas of the resected tumor will be compared to enhancement zones of the ablation margin for any residual cancer.
Time frame: 6 months post-Percutaneous Cryotherapy (PTC)
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