Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Pleural Neoplasms

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

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).

Cryoablation

Hiran Fernando, MD

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.

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).

All participants received the same treatment.

Safety and Efficacy of Cryoablation for Metastatic Lung Tumors

Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients - Safety and Efficacy

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 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.

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.

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.

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.

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.

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.

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).

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.

Evidence of additional metastatic disease post cryoablation procedure as measured by imaging is presented.

Boston Scientific Corporation

Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).

Participants underwent 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 were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

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.

Eastern Cooperative Oncology Group (ECOG) Performance Status

Physical Function as Assessed by the Karnofsky Performance Status (KPS) Scale

Physical Functioning

Role Physical

Bodily Pain

Social Functioning

Mental Health

Role Emotional

Vitality

General Health Perception

Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure

Sr. Clinical Trial Specialist

Local Control, Month 60

Complete Response, Month 60

Partial Response, Month 60

Stable Disease, Month 60

Local Failure, Month 60

Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.

Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 60

Local Control, Month 3

Local Control, Month 6

Local Control, Month 12

Local Control, Month 24

Local Control, Month 48

Local Control, Month 36

Complete Response, Month 3

Complete Response, Month 6

Complete Response, Month 12

Complete Response, Month 24

Complete Response, Month 36

Complete Response, Month 48

Partial Response, Month 3

Partial Response, Month 6

Partial Response, Month 12

Partial Response, Month 24

Partial Response, Month 36

Partial Response, Month 48

Stable Disease, Month 3

Stable Disease, Month 6

Stable Disease, Month 12

Stable Disease, Month 24

Stable Disease, Month 36

Stable Disease, Month 48

Local Failure, Month 3

Local Failure, Month 6

Local Failure, Month 12

Local Failure, Month 24

Local Failure, Month 36

Local Failure, Month 48

Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48

Week 1

Month 1

Month 3

Month 6

Month 12

Month 24

Month 36

Month 48

Month 60

Overall Disease-Specific Participant Survival Post-Cryoablation

Baseline

Week 1 (7 days)

Month 1 (30 days)

Month 3 (90 days)

Month 6 (180 days)

Month 12 (365 days)

Month 24 (730 days)

Month 36 (1095 days)

Month 48 (1460 days)

Month 60 (1825 days)

Time in Days to Disease Recurrence or Progression Following Study Cryoablation

Change at Week 1

Change at Month 1

Change at Month 3

Change at Month 6

Change at Month 12

Change at Month 24

Change at Month 36

Change at Month 48

Change at Month 60

Change From Baseline in ECOG Performance Status at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60

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

Physical Functioning, Change at Month 1

Physical Functioning, Change at Month 3

Physical Functioning, Change at Month 6

Physical Functioning, Change at Month 12

Physical Functioning, Change at Month 24

Physical Functioning, Change at Month 36

Physical Functioning, Change at Month 48

Physical Functioning, Change at Month 60

Role Physical, Change at Month 1

Role Physical, Change at Month 3

Role Physical, Change at Month 6

Role Physical, Change at Month 12

Role Physical, Change at Month 24

Role Physical, Change at Month 36

Role Physical, Change at Month 48

Role Physical, Change at Month 60

Bodily Pain, Change at Month 1

Bodily Pain, Change at Month 3

Bodily Pain, Change at Month 6

Bodily Pain, Change at Month 12

Bodily Pain, Change at Month 24

Bodily Pain, Change at Month 36

Bodily Pain, Change at Month 48

Bodily Pain, Change at Month 60

Social Functioning, Change at Month 1

Social Functioning, Change at Month 3

Social Functioning, Change at Month 6

Social Functioning, Change at Month 12

Social Functioning, Change at Month 24

Social Functioning, Change at Month 36

Social Functioning, Change at Month 48

Social Functioning, Change at Month 60

Mental Health, Change at Month 1

Mental Health, Change at Month 3

Mental Health, Change at Month 6

Mental Health, Change at Month 12

Mental Health, Change at Month 24

Mental Health, Change at Month 36

Mental Health, Change at Month 48

Mental Health, Change at Month 60

Role Emotional, Change at Month 1

Role Emotional, Change at Month 3

Role Emotional, Change at Month 6

Role Emotional, Change at Month 12

Role Emotional, Change at Month 24

Role Emotional, Change at Month 36

Role Emotional, Change at Month 48

Role Emotional, Change at Month 60

Vitality, Change at Month 1

Vitality, Change at Month 3

Vitality, Change at Month 6

Vitality, Change at Month 12

Vitality, Change at Month 24

Vitality, Change at Month 36

Vitality, Change at Month 48

Vitality, Change at Month 60

General Health Perception, Change at Month 1

General Health Perception, Change at Month 3

General Health Perception, Change at Month 6

General Health Perception, Change at Month 12

General Health Perception, Change at Month 24

General Health Perception, Change at Month 36

General Health Perception, Change at Month 48

General Health Perception, Change at Month 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

Cryoablation Technical Success of the Study Cryoablation Procedure

Intra-operative nonserious AE (NSAE)

Post-operative NSAE, prior to discharge

Post-operative NSAE within 30 days of procedure

Serious AE

UADE

Number of Participants With an Intra- or Post-operative Adverse Event (AE), a Serious AE, or an Unanticipated Adverse Device Effect (UADE)

Metastatic Disease Spread as Measured by Imaging

Overall Study

Spots Global Cancer Trial Database for Safety and Efficacy of Cryoablation for Metastatic Lung Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial