NCT01325753撤回不适用
A Pilot Study of Cryoablation for Patients With Oligometastatic Cancer Involving the Lung
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Safety of interventional cryoablation to the lung
研究概览
简要总结
This pilot clinical trial studies the side effects of cryotherapy (cryoablation [CA]) in treating patients with lung cancer. Cryotherapy kills cancer cells by freezing them.
详细描述
PRIMARY OBJECTIVES:
I. Assess the initial safety of the CA for lung tumors less than or equal to 3.5 cm in size including acute toxicity (30 days).
SECONDARY OBJECTIVES:
I. Estimate local control.
II. To assess physical function for this cohort of patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with American Joint Committee on Cancer (AJCC) seventh edition metastatic carcinoma or sarcoma involving the lungs or pleura.
- •Pathologic diagnosis of stage 4 cancer prior to enrollment by biopsy or on imaging with known (biopsied) primary disease
- •The target lesion is determined (by CT or magnetic resonance imaging [MRI] images) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs and structures
- •Maximum number of lesions per patient will be 5 total (a maximum of 3 on either the right or left side and 2 lesions on the respective contralateral side)
- •Of these, any lesion not treated with cryoablation will be planned to be treated with radiotherapy or radiofrequency ablation, such that all known active pulmonary disease is planned to be treated with a definitive local therapy
- •If treatment of both lungs is to occur by cryoablation, these treatments must be separated by at least one week
- •The lesion(s) treated with cryoablation may be intrapulmonary or pleural and must be =< 3.5 cm in greatest dimension
- •All patients are required to have been evaluated either in consultation with a radiation oncologist or at least in a multi-disciplinary tumor conference to ensure that all local therapy options are appropriately considered for each patient
- •Performance Status 0-2 (Eastern Cooperative Oncology Group [ECOG]); Karnofsky Performance Scale >= 60
- •Life expectancy > 3 months
- •Clinically suitable for cryoablation procedure as determined by the treating physician
- •Platelet count > 50,000/mm^3 within 60 days prior to study registration
- •International normalized ratio (INR) < 1.5 within 60 days prior to study registration
- •Absolute neutrophil count (ANC) < 1000 within 21 days prior to study registration
- •A signed study specific consent form is required
排除标准
- •Primary lung cancer
- •Unable to lie flat or has respiratory distress at rest
- •Uncontrolled coagulopathy or bleeding disorders
- •Evidence of active systemic, pulmonary, or pericardial infection
- •Pregnant, nursing or wishes to become pregnant during the study
- •Debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up
- •Currently participating in other experimental studies that could affect the primary endpoint
研究组 & 干预措施
Treatment (cryoablation)
Experimental
Patients undergo CT-guided CA.
干预措施: cryotherapy (Procedure)
Treatment (cryoablation)
Experimental
Patients undergo CT-guided CA.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Safety of interventional cryoablation to the lung
时间窗: 6 months
Unexpected toxiticities or Grade 4 or 5 toxicities will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).
次要结局
- Local control measured by imaging(At 1 year)
- Changes in Physical function and quality of life(approximately 60 months)
- Changes in pulmonary function(At 3 months)
- Obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial(approximately 60 months)
研究者
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