Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients - Safety and Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 60
研究概览
简要总结
ECLIPSE will evaluate the safety and efficacy of cryoablation therapy used to treat tumors less than or equal to 3.5 centimeters (cm) in participants with pulmonary metastatic disease.
详细描述
ECLIPSE is a treatment, Phase 1 multicenter, prospective, single-arm study with participants serving as their own control. This study is to enroll participants who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5 cm. Participants will be followed for 5 years post their cryoablation procedure.
Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal), and urology (kidney).
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
- •Participant must be at least 18 years old.
- •Participant has signed a written informed consent.
- •Participant presents with Stage 4 pulmonary metastatic disease with metastatic disease previously confirmed by prior biopsy or confirmed on imaging with known primary disease.
- •Participant has up to 3 local metastases unilaterally targeted by cryoablation. Maximum of 5 total pulmonary tumors bilaterally.
- •Targeted tumor(s) defined as intra pulmonary or pleural with a maximum size of 3.5 cm.
- •The target tumor is determined (by CT/MRI) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs and structures.
- •Eastern Cooperative Oncology Group (ECOG) score of 0-
- •Karnofsky Performance Scale (KPS) score ≥
- •Platelet count >50,000/cubed millimeters (mm^3) within 60 days prior to study treatment.
- •International normalized ratio (INR) less than 1.5 within 60 days prior to study treatment.
- •Participant has a life expectancy of >3 months.
- •Participant is clinically suitable for cryoablation procedure.
排除标准
- •Participant's primary cancer is lung cancer.
- •Participant is unable to lie flat or has respiratory distress at rest.
- •Participant has uncontrolled coagulopathy or bleeding disorders.
- •Participant has had chemotherapy with neutropenia to levels as confirmed by absolute neutrophil count (ANC) of less than 1000 that produce increase risk for the cryoablation procedure.
- •Participant has a history of an allergic reaction to iodine injections or to shellfish.
- •Participant has evidence of active systemic, pulmonary, or pericardial infection.
- •Participant has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up.
- •Participant is currently participating in other experimental studies that could affect the primary endpoint.
结局指标
主要结局
Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 60
时间窗: Baseline and Month 60
Local tumor control was achieved if either the greatest trans-axial diameter of a treated tumor was ≤20% greater than at the pre-procedure assessment (per-tumor assessment) or if the sum of greatest trans-axial diameters of all treated tumors for a participant was ≤20% greater than the sum for the pre-procedure assessment of those tumors (per-participant assessment). Complete Response defined as tumor disappearance (scar) or \<25% of original size. If tumor/ablation zone had likely disappeared, the measurement was recorded as 0 mm; if tumor/ablation zone was present but too small to measure, the measurement was recorded as 5 mm. Partial Response defined as greater than 30% decrease in sum of the largest diameter of all targeted tumors. Stable Disease defined as less than 30% decrease in sum of the largest diameter of all targeted tumors. Local Failure defined as greater than 20% increase in the sum of the largest diameter of all targeted tumors. Worst response per participant was used.
次要结局
- Overall Disease-Specific Participant Survival Post-Cryoablation(Up to Month 60)
- Time in Days to Disease Recurrence or Progression Following Study Cryoablation(Baseline (0 days), Week 1 (7 days), and Months 3 (90 days), 6 (180 days), 12 (365 days), 24 (730 days), 36 (1095 days), 48 (1460 days), and 60 (1825 days))
- Change From Baseline in Physical Function as Assessed by the KPS Scale at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60(Baseline, Week 1 and Months 3, 6, 12, 24, 36, 48, and 60)
- Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48(Baseline and Months 3, 6, 12, 24, 36, and 48)
- Cryoablation Technical Success of the Study Cryoablation Procedure(Up to 60 months)
- Change From Baseline in ECOG Performance Status at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60(Baseline, Week 1 and Months 3, 6, 12, 24, 36, 48, and 60)
- Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60(Baseline, Months 1, 3, 6, 12, 24, 36, 48, and 60)
- Number of Participants With an Intra- or Post-operative Adverse Event (AE), a Serious AE, or an Unanticipated Adverse Device Effect (UADE)(Baseline up to 30 days post-cryoablation)
- Metastatic Disease Spread as Measured by Imaging(Months 3, 6, 12, 24, 36, 48, and 60)