A Pilot Study of Percutaneous Cryotherapy as Treatment for Stage I Lung Cancer or Solitary Metastatic Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- The Number of Patients With a Response (Complete Response and Partial Response)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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
干预措施: Cryotherapy (PTC) (Procedure)
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
干预措施: Prednisone (Drug)
结局指标
主要结局
The Number of Patients With a Response (Complete Response and Partial Response)
时间窗: 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).
次要结局
- The Number of Patients With a Pathologic Response(6 months post-Percutaneous Cryotherapy (PTC))
研究者
Frank Baciewicz Jr.
Principal Investigator
Barbara Ann Karmanos Cancer Institute