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Study of Cryoablation for Metastatic Lung Tumors (SOLSTICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01957787
Recruitment Status : Completed
First Posted : October 8, 2013
Results First Posted : August 28, 2019
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Galil Medical, a wholly owned indirect subsidiary of Boston Scientific

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of cryoablation therapy used to treat tumors in participants with pulmonary metastatic disease. 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 centimeter (cm). Participants will be followed 24 months post their cryoablation procedure.

Condition or disease Intervention/treatment Phase
Neoplasm Metastasis Device: Cryoablation Not Applicable

Detailed Description:

Treatment for pulmonary metastatic disease may include surgery, chemotherapy, radiation therapy, or a combination of treatments. However, several variables may exclude participants from these treatments such as multiple tumors, multiple previous surgeries, pulmonary dysfunction, or co-morbid medical conditions. For these participants, percutaneous cryoablation may be a suitable option.

Ablation of metastatic lung tumors is a rapidly expanding area within interventional oncology. Cryotherapy, radiofrequency, laser, and microwave have all been shown to be effective. Cryotherapy offers a wide range of anatomic and tumor treatment options because of the ability to visualize the ice under imaging guidance and the preservation of collagenous tissue structure. Cryoablation has been extensively performed in the prostate and kidney with favorable outcomes reported in the literature. More recently, cryoablation has been shown to be safe in the treatment of lung tumors with CT guidance.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation
Actual Study Start Date : April 10, 2014
Actual Primary Completion Date : March 9, 2017
Actual Study Completion Date : August 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cryoablation
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. Tumors in both lungs are to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session will not be performed. All participants will receive cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors are to be completed within an 8-week window.
Device: Cryoablation
Application of extremely cold temperatures to the identified tumor(s).
Other Names:
  • Cryotherapy
  • Visual-ICE® Cryoablation System
  • PresIce® Cryoablation System
  • SeedNet® Cryoablation System
  • IceEDGE® 2.4 Cryoablation Needles
  • IceRod® PLUS Cryoablation Needles
  • IceSphere™ Cryoablation Needles




Primary Outcome Measures :
  1. Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 12 [ Time Frame: Month 1 (Month 3 if Month 1 Data was missing) and Month 12 ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With an Intra- or Post-operative Adverse Event, a Serious Adverse Event, or an Unanticipated Adverse Device Effect [ Time Frame: Baseline up to 30 days post-cryoablation ]
    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.


Other Outcome Measures:
  1. Local Tumor Control for Each Index Tumor at Month 18 and Month 24 [ Time Frame: Month 1 (Month 3 if Month 1 Data was missing), Month 18 and Month 24 ]
    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.

  2. Overall Participant Survival Post-cryoablation [ Time Frame: Up to Month 24 ]
    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.

  3. Time to Metastatic Lung Disease Progression Beyond the Index Tumor(s) [ Time Frame: Up to Month 24 ]
    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).

  4. Time to Overall Cancer Progression [ Time Frame: Up to Month 24 ]
    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).

  5. Local Tumor Control With Additional Cryoablation Galil Medical Technology Treatment(s) of a Previously Treated Index Tumor [ Time Frame: Up to Month 12 ]
    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.

  6. Time to Untreatable Metastatic Lung Disease Control With Cryoablation (Free From Metastatic Lung Disease) [ Time Frame: Month 12 (Days 181-365) and Month 24 (Days 495-730) ]
    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.

  7. Time to Untreatable Metastatic Lung Disease Control With Focal Therapy (Free From Metastatic Lung Disease) [ Time Frame: Month 12 (Days 181-365) and Month 24 (Days 495-730) ]
    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.

  8. Cryoablation Technical Success at Month 1 [ Time Frame: Up to Month 1 ]
    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.

  9. Change From Baseline in Physical Function as Assessed by the Karnofsky Performance Status (KPS) Scale at Months 1, 3, 6, 12, 18, and 24 [ Time Frame: Baseline, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24 ]
    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.

  10. 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 [ Time Frame: Baseline, Month 1 and Month 3 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Participant presents with Stage 4 pulmonary metastatic disease previously confirmed on imaging (for example, computerized tomography or CT) with histology proven primary cancer.
  • Participant has up to 6 local pulmonary metastases targetable by cryoablation.
  • Targeted index tumor(s) defined as intra pulmonary or pleural with a maximum size of 3.5 cm, measured in the longest cross-sectional dimension.
  • The target index tumor(s) is determined (by CT images) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs/ structures and is greater than 0.5 cm from any critical organ/structure (possibly achieved with additional maneuvers such as iatrogenic pneumothorax or hydrodissection).
  • Karnofsky Performance Scale (KPS) score greater than or equal to 60.
  • Platelet count greater than 50,000/millimeters (mm)^3 within 8 weeks prior to initial cryoablation procedure.
  • International Normalized Ratio (INR) less than 1.5 within 8 weeks prior to initial cryoablation procedure.
  • Participant has a life expectancy of greater than 3 months.

Exclusion Criteria:

  • Participant's index tumor(s) is primary lung cancer.
  • Participant has uncontrollable primary or metastatic disease outside of the lung.
  • Participant is unable to lie flat or has respiratory distress at rest.
  • Participant has a coagulopathy or bleeding disorder which is uncontrolled.
  • Absolute Neutrophil Count (ANC) <1000 within 8 weeks prior to initial cryoablation procedure.
  • 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 (for example, experimental chemotherapy regimen).

Information from the National Library of Medicine

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): NCT01957787


Locations
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United States, California
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States, 90095
United States, Georgia
Cancer Treatment Centers of America at Southeastern Regional Medical Center
Newnan, Georgia, United States, 30265
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
New York Presbyterian Hospital - Cornell Medical Center
New York, New York, United States, 10065
State University of New York at Stony Brook
Stony Brook, New York, United States, 11794
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Virginia
Inova Alexandria Hospital CVIR
Alexandria, Virginia, United States, 22304
France
Institut Bergonié
Bordeaux, Aquitaine, France, 33070
Institut Gustave Roussy
Villejuif, Ile-de-France, France, 94805
Sponsors and Collaborators
Galil Medical, a wholly owned indirect subsidiary of Boston Scientific
Investigators
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Study Chair: Thierry de Baere, MD Gustave Roussy, Cancer Campus, Grand Paris
Study Chair: Matthew Callstrom, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Galil Medical, a wholly owned indirect subsidiary of Boston Scientific:
Study Protocol  [PDF] February 3, 2014
Statistical Analysis Plan  [PDF] January 4, 2017

Publications:

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Responsible Party: Galil Medical, a wholly owned indirect subsidiary of Boston Scientific
ClinicalTrials.gov Identifier: NCT01957787    
Other Study ID Numbers: CUC13-LNG079
First Posted: October 8, 2013    Key Record Dates
Results First Posted: August 28, 2019
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Galil Medical, a wholly owned indirect subsidiary of Boston Scientific:
Metastatic lung tumors
Pulmonary metastatic disease
Additional relevant MeSH terms:
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Neoplasm Metastasis
Lung Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases