Trial Outcomes & Findings for Study of Cryoablation for Metastatic Lung Tumors (NCT NCT01957787)
NCT ID: NCT01957787
Last Updated: 2021-07-19
Results Overview
Local tumor control defined as the absence of local treatment failure 12 months following study cryoablation based on site-reported data. Local control was achieved if the 3-axis measurement (that is, the greatest trans-axial diameter plus the 2 perpendicular diameters) of a tumor at Month 12 was less than 20% larger than the 3-axis measurement of the tumor at Month 1 following study cryoablation. A separate evaluation of local tumor control at Month 12 following cryoablation was completed per index tumor. Month 1 data served as the baseline for this analysis; if Month 1 data was missing, Month 3 data were used. Tumors with a local failure at the prior study visit and those with repeat cryoablation procedures prior to Month 12 were counted as failures. Imaging for assessment of tumor measurements was performed using CT or 18 F-fluorodeoxyglucose positron emission tomography-CT with or without contrast.
COMPLETED
NA
131 participants
Month 1 (Month 3 if Month 1 Data was missing) and Month 12
2021-07-19
Participant Flow
Unit of analysis: Number of Index Tumors
Participant milestones
| Measure |
Cryoablation
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. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window.
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|---|---|
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Overall Study
STARTED
|
131 226
|
|
Overall Study
Intent-to-Treat (ITT) Population
|
130 226
|
|
Overall Study
Modified ITT (mITT) Population
|
128 224
|
|
Overall Study
COMPLETED
|
95 170
|
|
Overall Study
NOT COMPLETED
|
36 56
|
Reasons for withdrawal
| Measure |
Cryoablation
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. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window.
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|---|---|
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Overall Study
Death
|
18
|
|
Overall Study
Lost to Follow-up
|
3
|
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Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Entered Hospice or Similar Program
|
2
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|
Overall Study
Index Tumor(s) Resected
|
2
|
|
Overall Study
Index Tumor was Primary Lung Cancer
|
2
|
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Overall Study
Local therapy, not cryoablation
|
6
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Baseline Characteristics
Study of Cryoablation for Metastatic Lung Tumors
Baseline characteristics by cohort
| Measure |
Cryoablation
n=128 Participants
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. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window.
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|---|---|
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Age, Continuous
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63.4 years
STANDARD_DEVIATION 11.9 • n=5 Participants
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|
Sex: Female, Male
Female
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60 Participants
n=5 Participants
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Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
59 Participants
n=5 Participants
|
|
Number of Index Tumors Per Participant
1 Tumor
|
79 Participants
n=5 Participants
|
|
Number of Index Tumors Per Participant
2 Tumors
|
23 Participants
n=5 Participants
|
|
Number of Index Tumors Per Participant
3 Tumors
|
15 Participants
n=5 Participants
|
|
Number of Index Tumors Per Participant
4 Tumors
|
5 Participants
n=5 Participants
|
|
Number of Index Tumors Per Participant
5 Tumors
|
2 Participants
n=5 Participants
|
|
Number of Index Tumors Per Participant
6 Tumors
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4 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Month 1 (Month 3 if Month 1 Data was missing) and Month 12Population: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population). Multiple imputation methods for missing data were applied.
Local tumor control defined as the absence of local treatment failure 12 months following study cryoablation based on site-reported data. Local control was achieved if the 3-axis measurement (that is, the greatest trans-axial diameter plus the 2 perpendicular diameters) of a tumor at Month 12 was less than 20% larger than the 3-axis measurement of the tumor at Month 1 following study cryoablation. A separate evaluation of local tumor control at Month 12 following cryoablation was completed per index tumor. Month 1 data served as the baseline for this analysis; if Month 1 data was missing, Month 3 data were used. Tumors with a local failure at the prior study visit and those with repeat cryoablation procedures prior to Month 12 were counted as failures. Imaging for assessment of tumor measurements was performed using CT or 18 F-fluorodeoxyglucose positron emission tomography-CT with or without contrast.
Outcome measures
| Measure |
Cryoablation
n=224 Number of Tumors
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. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window.
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|---|---|
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 12
|
84.6 percentage of tumors
Interval 78.6 to 89.2
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SECONDARY outcome
Timeframe: Baseline up to 30 days post-cryoablationPopulation: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
The number of participants with the following categories of adverse events is presented: an intra-operative, a post-operative, a serious adverse event, or an unanticipated adverse device effect. The adverse events that are presented are related to the cryoablation procedure. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Cryoablation
n=130 Participants
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. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window.
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|---|---|
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Number of Participants With an Intra- or Post-operative Adverse Event, a Serious Adverse Event, or an Unanticipated Adverse Device Effect
Intra-operative nonserious adverse event
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39 Participants
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Number of Participants With an Intra- or Post-operative Adverse Event, a Serious Adverse Event, or an Unanticipated Adverse Device Effect
Post-operative nonserious adverse event
|
18 Participants
|
|
Number of Participants With an Intra- or Post-operative Adverse Event, a Serious Adverse Event, or an Unanticipated Adverse Device Effect
Serious adverse events
|
15 Participants
|
|
Number of Participants With an Intra- or Post-operative Adverse Event, a Serious Adverse Event, or an Unanticipated Adverse Device Effect
Intra-operative serious adverse event
|
4 Participants
|
|
Number of Participants With an Intra- or Post-operative Adverse Event, a Serious Adverse Event, or an Unanticipated Adverse Device Effect
Post-operative serious adverse event
|
4 Participants
|
|
Number of Participants With an Intra- or Post-operative Adverse Event, a Serious Adverse Event, or an Unanticipated Adverse Device Effect
Unanticipated adverse device effect
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 1 (Month 3 if Month 1 Data was missing), Month 18 and Month 24Population: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population). Multiple imputation methods for missing data were applied.
Local tumor control defined as the absence of local treatment failure 18 and 24 months following study cryoablation based on site-reported data. Local control was achieved if the 3-axis measurement (that is, the greatest trans-axial diameter plus the 2 perpendicular diameters) of a tumor at Month 12 was less than 20% larger than the 3-axis measurement of the tumor at Month 1 following study cryoablation. A separate evaluation of local tumor control at Month 12 following cryoablation was completed per index tumor. Month 1 data served as the baseline for this analysis; if Month 1 data was missing, Month 3 data were used. Tumors with a local failure at the prior study visit and those with repeat cryoablation procedures prior to Month 12 were counted as failures. Imaging for assessment of tumor measurements was performed using CT or 18 F-fluorodeoxyglucose positron emission tomography-CT with or without contrast.
Outcome measures
| Measure |
Cryoablation
n=224 Number of Tumors
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. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window.
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|---|---|
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Local Tumor Control for Each Index Tumor at Month 18 and Month 24
Month 18
|
82.3 percentage of tumors
Interval 75.9 to 87.4
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Local Tumor Control for Each Index Tumor at Month 18 and Month 24
Month 24
|
75.1 percentage of tumors
Interval 66.3 to 82.2
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OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Month 24Population: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population).
Overall survival rate was defined as the time in days from the first cryoablation procedure to death. Participants who were alive were censored at the date of the last visit.
Outcome measures
| Measure |
Cryoablation
n=128 Participants
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. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window.
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|---|---|
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Overall Participant Survival Post-cryoablation
0-7 Days
|
100 percentage of participants
|
|
Overall Participant Survival Post-cryoablation
8-30 Days
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100 percentage of participants
|
|
Overall Participant Survival Post-cryoablation
31-90 Days
|
100 percentage of participants
|
|
Overall Participant Survival Post-cryoablation
91-180 Days
|
100 percentage of participants
|
|
Overall Participant Survival Post-cryoablation
181-365 Days
|
97.6 percentage of participants
|
|
Overall Participant Survival Post-cryoablation
366-730 Days
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86.6 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Month 24Population: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population).
Time to metastatic lung disease progression beyond the index tumor was defined as the time in days from the first cryoablation procedure to metastatic disease beyond the index tumor site. Participants without metastatic lung disease progression were censored at the date of their last visit or their date of death (due to any cause).
Outcome measures
| Measure |
Cryoablation
n=128 Participants
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. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window.
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|---|---|
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Time to Metastatic Lung Disease Progression Beyond the Index Tumor(s)
|
515 days
Interval 351.0 to 733.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Month 24Population: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population).
Time to overall cancer progression was defined as the time in days from the first cryoablation procedure to cancer progression (that is, any location of active cancer disease). Participants without cancer progression were censored at the date of their last visit or their date of death (due to any cause).
Outcome measures
| Measure |
Cryoablation
n=128 Participants
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. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window.
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|---|---|
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Time to Overall Cancer Progression
|
173 days
Interval 103.0 to 279.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Month 12Population: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population) and underwent an additional Cryoablation Galil Medical Technology Treatment.
Local tumor control, defined as absence of local treatment failure 12 months following study cryoablation based on site-reported data, was achieved if 3-axis measurement (that is, greatest trans-axial diameter plus 2 perpendicular diameters) of a tumor at Month 12 was \<20% larger than 3-axis measurement of the tumor at Month 1 following study cryoablation. Separate evaluation of local tumor control at Month 12 following cryoablation was completed per index tumor. Follow-up visits were re-started after additional treatment, per study protocol and continued through the Month 24 visit after the last study cryoablation. Month 1 data served as baseline for analysis; if Month 1 data was missing, Month 3 data were used. Tumors with a local failure at prior study visit and with repeat cryoablation procedures prior to Month 12 were counted as failures. Tumor measurement imaging performed using CT or 18 F-fluorodeoxyglucose positron emission tomography-CT with or without contrast.
Outcome measures
| Measure |
Cryoablation
n=16 Number of Tumors
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. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window.
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|---|---|
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Local Tumor Control With Additional Cryoablation Galil Medical Technology Treatment(s) of a Previously Treated Index Tumor
|
100 percentage of tumors
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OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12 (Days 181-365) and Month 24 (Days 495-730)Population: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population) with available data at the respective time point.
Time to untreatable metastatic lung disease control with cryoablation is defined as the time in days from the first cryoablation procedure to the time when the metastatic lung disease cannot be treated with cryoablation. The percentage of participants free from metastatic disease that is untreatable with cryoablation at the intervals of time of Days 181 to 365 and Days 495 to 730 is presented.
Outcome measures
| Measure |
Cryoablation
n=128 Participants
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. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window.
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|---|---|
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Time to Untreatable Metastatic Lung Disease Control With Cryoablation (Free From Metastatic Lung Disease)
Month 12 (Days 181-365)
|
83.3 percentage of participants
|
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Time to Untreatable Metastatic Lung Disease Control With Cryoablation (Free From Metastatic Lung Disease)
Month 24 (Days 495-730)
|
72.2 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12 (Days 181-365) and Month 24 (Days 495-730)Population: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population) with available data at the respective time point.
Time to untreatable metastatic lung disease control with focal therapy defined as the time in days from the first cryoablation procedure to the time when the metastatic lung disease cannot be treated by focal (for example, ablation, surgery, SBRT) intervention for control of metastatic lung disease. The percentage of participants free from metastatic disease that is untreatable with focal therapy at the intervals of time of Days 181 to 365 and Days 495 to 730 is presented.
Outcome measures
| Measure |
Cryoablation
n=128 Participants
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. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window.
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|---|---|
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Time to Untreatable Metastatic Lung Disease Control With Focal Therapy (Free From Metastatic Lung Disease)
Month 12 (Days 181-365)
|
81.7 percentage of participants
|
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Time to Untreatable Metastatic Lung Disease Control With Focal Therapy (Free From Metastatic Lung Disease)
Month 24 (Days 495-730)
|
72.4 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Month 1Population: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population).
A technically successful treatment was defined by the presence of an ablation zone, ground glass opacity, or frank consolidation encompassing the targeted index tumor(s) at no later than the 1 month follow up visit after the cryoablation procedure. Technical success rates and 95% confidence intervals (CIs) were calculated using random effects logistic regression on a tumor level.
Outcome measures
| Measure |
Cryoablation
n=224 Number of Tumors
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. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window.
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|---|---|
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Cryoablation Technical Success at Month 1
|
97.2 percentage of tumors
Interval 93.3 to 98.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24Population: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population) and evaluable KPS scores.
The KPS scale is a standard way of measuring the ability of cancer participants to perform ordinary tasks. KPS may be used to determine a participant's prognosis and to measure changes in a participant's ability to function. Assessments were made by examining the change in the baseline scores to those reported post-operatively. KPS scores range from 0 to 100. A higher score means the participant is better able to carry out daily activities.
Outcome measures
| Measure |
Cryoablation
n=128 Participants
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. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window.
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|---|---|
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Change From Baseline in Physical Function as Assessed by the Karnofsky Performance Status (KPS) Scale at Months 1, 3, 6, 12, 18, and 24
Month 1
|
-1.14 units on a scale
Standard Deviation 6.80
|
|
Change From Baseline in Physical Function as Assessed by the Karnofsky Performance Status (KPS) Scale at Months 1, 3, 6, 12, 18, and 24
Month 3
|
-1.34 units on a scale
Standard Deviation 8.12
|
|
Change From Baseline in Physical Function as Assessed by the Karnofsky Performance Status (KPS) Scale at Months 1, 3, 6, 12, 18, and 24
Month 6
|
-1.08 units on a scale
Standard Deviation 8.35
|
|
Change From Baseline in Physical Function as Assessed by the Karnofsky Performance Status (KPS) Scale at Months 1, 3, 6, 12, 18, and 24
Month 12
|
-1.86 units on a scale
Standard Deviation 8.64
|
|
Change From Baseline in Physical Function as Assessed by the Karnofsky Performance Status (KPS) Scale at Months 1, 3, 6, 12, 18, and 24
Month 18
|
-3.82 units on a scale
Standard Deviation 12.29
|
|
Change From Baseline in Physical Function as Assessed by the Karnofsky Performance Status (KPS) Scale at Months 1, 3, 6, 12, 18, and 24
Month 24
|
-5.00 units on a scale
Standard Deviation 16.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Month 1 and Month 3Population: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population) and evaluable SF-12 scores.
The SF-12 is a shortened version of the well-known SF-36. The SF-12 assesses 8 domains (physical functioning, role limitations due to physical health problems, bodily pain, social functioning, general mental health, role limitations due to emotional problems, vitality, general health perception). The shorter instrument provides a general measurement of quality of life. 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.
Outcome measures
| Measure |
Cryoablation
n=128 Participants
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. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window.
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|---|---|
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Change From Baseline in Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure at Month 1 and Month 3
Physical Functioning, Month 1
|
-3.9 units on a scale
Standard Deviation 28.5
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure at Month 1 and Month 3
Physical Functioning, Month 3
|
-3.2 units on a scale
Standard Deviation 28.7
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure at Month 1 and Month 3
Role Physical, Month 1
|
1.6 units on a scale
Standard Deviation 34.3
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure at Month 1 and Month 3
Role Physical, Month 3
|
3.9 units on a scale
Standard Deviation 35.9
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure at Month 1 and Month 3
Bodily Pain, Month 1
|
-1.6 units on a scale
Standard Deviation 26.6
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure at Month 1 and Month 3
Bodily Pain, Month 3
|
-2.4 units on a scale
Standard Deviation 26.4
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure at Month 1 and Month 3
Social Functioning, Month 1
|
3.3 units on a scale
Standard Deviation 23.7
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure at Month 1 and Month 3
Social Functioning, Month 3
|
0.9 units on a scale
Standard Deviation 29.1
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure at Month 1 and Month 3
Mental Health, Month 1
|
2.9 units on a scale
Standard Deviation 20.1
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure at Month 1 and Month 3
Mental Health, Month 3
|
3.0 units on a scale
Standard Deviation 23.1
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure at Month 1 and Month 3
Role Emotional, Month 1
|
-2.0 units on a scale
Standard Deviation 25.8
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure at Month 1 and Month 3
Role Emotional, Month 3
|
2.6 units on a scale
Standard Deviation 24.8
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure at Month 1 and Month 3
Vitality, Month 1
|
-2.7 units on a scale
Standard Deviation 29.4
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure at Month 1 and Month 3
Vitality, Month 3
|
-1.3 units on a scale
Standard Deviation 29.7
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure at Month 1 and Month 3
General Health Perception, Month 1
|
-2.3 units on a scale
Standard Deviation 25.1
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure at Month 1 and Month 3
General Health Perception, Month 3
|
-2.2 units on a scale
Standard Deviation 23.7
|
Adverse Events
Cryoablation
Serious adverse events
| Measure |
Cryoablation
n=130 participants at risk
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. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window.
|
|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
General disorders
Gait imbalance
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Infections and infestations
Abdominal infection
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Nervous system disorders
Headache
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
2.3%
3/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural hemorrhage
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.9%
9/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Vascular disorders
Gaseous embolism
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
Other adverse events
| Measure |
Cryoablation
n=130 participants at risk
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. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window.
|
|---|---|
|
Cardiac disorders
Sinus tachycardia
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Gastrointestinal disorders
Abdominal distention
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Gastrointestinal disorders
Diarrhea
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Gastrointestinal disorders
Nausea
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Gastrointestinal disorders
Vomiting
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
General disorders
Bilateral leg edema
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
General disorders
Chest pain
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
General disorders
Fatigue
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
General disorders
Non-cardiac chest pain
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
General disorders
Pain at needle site
|
9.2%
12/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Immune system disorders
Allergic reaction
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Infections and infestations
Device related infection
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Infections and infestations
Hepatic infection
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Infections and infestations
MRSA infected decubitus ulcer
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Infections and infestations
Upper respiratory infection
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Injury, poisoning and procedural complications
Burn
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Metabolism and nutrition disorders
Steroid induced hyperglycemia
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
2/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Nervous system disorders
Paresthesia
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Nervous system disorders
Radiculitis
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Renal and urinary disorders
Urinary retention
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
11.5%
15/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
3/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragm paralysis
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.3%
3/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Left-sided pleuritic pain
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
2/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
30.0%
39/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
1.5%
2/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.5%
2/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Skin and subcutaneous tissue disorders
Rash on face and abdomen
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Vascular disorders
Hematoma
|
0.77%
1/130 • Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
Additional Information
Sr. Clinical Trial Specialist
Galil Medical, a wholly owned indirect subsidiary of Boston Scientific
Results disclosure agreements
- Principal investigator is a sponsor employee Galil Medical can require Investigator to postpone publications/presentations for up to 12 months so data from all sites can be published. Galil Medical will limit review of Investigator's draft to confirm Confidential Information is not being disclosed. If Galil Medical notes publishing Study results may affect obtaining a patent, Investigator may not publish for up to 60 days until patent application is filed. Investigator will acknowledge Galil Medical in any publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER