Safety and Efficacy of Cryoablation for Metastatic Lung Tumors (ECLIPSE)
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|ClinicalTrials.gov Identifier: NCT01307501|
Recruitment Status : Completed
First Posted : March 3, 2011
Results First Posted : October 1, 2019
Last Update Posted : July 19, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Metastatic Lung Cancer||Device: Cryoablation||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants received the same treatment.|
|Masking:||None (Open Label)|
|Official Title:||Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients - Safety and Efficacy|
|Actual Study Start Date :||January 4, 2012|
|Actual Primary Completion Date :||August 30, 2018|
|Actual Study Completion Date :||August 30, 2018|
Participants will undergo a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure will be identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and will be at the discretion of the Investigators. No more than 3 tumors in 1 lung can be treated in a single session, and no more than 5 total lung tumors (across both lungs) can be treated during the study.
Application of extremely cold temperatures to the identified tumor(s).
- Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 60 [ Time Frame: 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.
- Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48 [ Time Frame: Baseline and Months 3, 6, 12, 24, 36, and 48 ]Local tumor control was achieved if 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 the 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.
- Overall Disease-Specific Participant Survival Post-Cryoablation [ Time Frame: Up to Month 60 ]Disease-specific survival was analyzed as time in days from study cryoablation to participant death due to lung cancer. All deaths with documented lung disease progression were categorized as disease-specific deaths for this analysis. Participants who were alive were censored at the date of their last visit. Participants who died from causes other than lung cancer and did not have documented disease progression were censored at the time of death.
- Time in Days to Disease Recurrence or Progression Following Study Cryoablation [ Time Frame: 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) ]Disease recurrence or progression will be determined locally by evidence of an increase in tumor size and/or contrast enhancement that met the definition of local tumor failure. Local tumor failure defined as a >20% increase from baseline in the sum of the largest diameter of all targeted tumors. Participants without disease recurrence or progression were censored at the date of their last visit or their date of death due to any cause. The percentage of participants with disease recurrence or progression after the study cryoablation procedure at the specified number of days is presented.
- Change From Baseline in ECOG Performance Status at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60 [ Time Frame: Baseline, Week 1 and Months 3, 6, 12, 24, 36, 48, and 60 ]ECOG Performance Status defined as a set of criteria with corresponding scores used by the Investigator to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. ECOG Performance Status Scoring: 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (for example, light house work, office work); 2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead.
- 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 [ Time Frame: Baseline, Week 1 and Months 3, 6, 12, 24, 36, 48, and 60 ]The KPS Scale is a standard way of measuring the ability of cancer patients to perform ordinary tasks. The scores range from 0 to 100. A higher score means the participant is better able to carry out daily activities. KPS may be used to determine a participant's prognosis, to measure changes in a participant's ability to function.
- 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 [ Time Frame: Baseline, Months 1, 3, 6, 12, 24, 36, 48, and 60 ]The SF-12 is a shortened version of the well-known SF-36. The SF-12 assesses eight domains (physical functioning, role limitations due to physical health problems, bodily pain, social functioning, general mental health, role limitations due to emotional problems, vitality and general health perception). Assessments were made by examining the change in the baseline scores to those reported post-operatively. The scores range from 0 to 100. A higher value indicates a better quality of life of the participant.
- Cryoablation Technical Success of the Study Cryoablation Procedure [ Time Frame: Up to 60 months ]A technically successful treatment was defined by an ablation volume encompassing the tumor with at least a 5 mm margin. Technical success was calculated on a per tumor level as well as a participant level. To be considered a technical success on a participant level, all tumors treated during the baseline procedure were required to meet the technical success criteria (that is, an ablation volume encompassing the tumor with at least a 5 mm margin).
- Number of Participants With an Intra- or Post-operative Adverse Event (AE), a Serious AE, or an Unanticipated Adverse Device Effect (UADE) [ Time Frame: Baseline up to 30 days post-cryoablation ]An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study. Serious AEs include death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent the previously listed serious outcomes. UADE was any serious adverse effect, any life-threatening problem or death caused by or associated with a device, if it was not previously identified in nature, severity, or degree of incidence in the application; or any other unanticipated serious problem associated with a device. The AEs that are presented were considered related to the cryoablation procedure. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
- Metastatic Disease Spread as Measured by Imaging [ Time Frame: Months 3, 6, 12, 24, 36, 48, and 60 ]Evidence of additional metastatic disease post cryoablation procedure as measured by imaging is presented.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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 0-2.
- Karnofsky Performance Scale (KPS) score ≥60.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307501
|United States, California|
|Ronald Regan UCLA Medical Center|
|Los Angeles, California, United States, 90095|
|United States, Michigan|
|Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, Minnesota|
|Mayo Clinic Rochester|
|Rochester, Minnesota, United States, 55905|
|Institut Gustave Roussy|
|Villejuif, Cedex, France, 94805|
|Study Chair:||Hiran Fernando, MD||Boston Medical Center|
Documents provided by Boston Scientific Corporation:
|Responsible Party:||Boston Scientific Corporation|
|Other Study ID Numbers:||
|First Posted:||March 3, 2011 Key Record Dates|
|Results First Posted:||October 1, 2019|
|Last Update Posted:||July 19, 2021|
|Last Verified:||July 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|