A Pilot Study of Percutaneous Cryotherapy as Treatment for Stage I Lung Cancer or Solitary Metastatic Lung Cancer
Overview
- Phase
- Phase 1
- Intervention
- Cryotherapy (PTC)
- Conditions
- Lung Cancer
- Sponsor
- Barbara Ann Karmanos Cancer Institute
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- The Number of Patients With a Response (Complete Response and Partial Response)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Frank Baciewicz Jr.
Principal Investigator
Barbara Ann Karmanos Cancer Institute
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Prednisone & Cryotherapy
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
Intervention: Cryotherapy (PTC)
Prednisone & Cryotherapy
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
Intervention: Prednisone
Outcomes
Primary Outcomes
The Number of Patients With a Response (Complete Response and Partial Response)
Time Frame: 3 weeks post-Percutaneous Cryotherapy (PTC)
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).
Secondary Outcomes
- The Number of Patients With a Pathologic Response(6 months post-Percutaneous Cryotherapy (PTC))