Percutaneous Thoracic Cryotherapy (PTC) for Inoperable Primary Lung Cancer and Metastatic Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Local Failure Rates by CT Scan
研究概览
简要总结
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.
详细描述
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.
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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed malignant pulmonary neoplasm
- •New lung lesion(s) with definitive clinical and imaging features of primary or metastatic disease allowed
- •Imaging findings compatible with localized treatment failure after prior cryotherapy allowed
- •Malignant pleural effusion allowed provided it is associated with a distinct measurable pulmonary mass amenable to cryotherapy
- •Metastatic disease must meet all of the following criteria:
- •Primary tumors have been resected or have been deemed controlled by other therapies
- •No other widespread metastases evident (e.g., multiple hepatic or brain metastases)
- •Each pulmonary mass must be amenable to CT-guided percutaneous cryotherapy approach
- •No more than 5 targeted masses for study therapy
- •Target mass defined as pulmonary, hilar, mediastinal, and/or chest wall mass > 1 cm, but < 10 cm in average diameter
- •Unresectable disease by surgical consultation OR patient refused surgical options
- •Nonenhanced and enhanced CT scan required within the past 6 weeks done at 4-5 mm increments with available soft tissue and mediastinal windows to assess size and extent of all thoracic tumors
- •PET scan required within the past 6 months noting the correlation with the above CT locations, if not already obtained by a combined PET/CT scanner
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status (PS) > 60-100% OR WHO/ECOG/Zubrod PS 0-2
- •FEV_1 > 30% of predicted
- •DLCO > 40% of predicted
- •Platelet count ≥ 70,000/mm^3
- •INR < 1.5
- •No uncontrolled coagulopathy or bleeding diathesis
- •Not pregnant or nursing
- •Negative pregnancy test
- •No serious medical illness, including any of the following:
- •Uncontrolled congestive heart failure
- •Uncontrolled angina
- •Myocardial infarction
- •Cerebrovascular event within 6 months prior to study entry
- •No medical contraindication or potential problem that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •At least 7 days since prior aspirin and aspirin-like medications
- •At least 3 days since prior warfarin, clopidogrel bisulfate, or similar compounds
- •No concurrent drugs causing bleeding tendencies (e.g., aspirin, warfarin, or clopidogrel bisulfate)
- •No concurrent participation in other experimental studies
排除标准
- 未提供
研究组 & 干预措施
cryosurgery
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.
干预措施: cryosurgery (Procedure)
cryosurgery
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.
干预措施: positron emission tomography (Procedure)
结局指标
主要结局
Local Failure Rates by CT Scan
时间窗: at 3, 6, and 12 months
Local Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
Distant Failure Rate
时间窗: at 3, 6, and 12 months
Distant Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
次要结局
- 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)
研究者
Peter John Littrup
Principal Investigator
Barbara Ann Karmanos Cancer Institute