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Study of Cryoablation for Metastatic Lung Tumors (SOLSTICE)

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ClinicalTrials.gov Identifier: NCT01957787
Recruitment Status : Active, not recruiting
First Posted : October 8, 2013
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Galil Medical

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of cryoablation therapy used to treat tumors in patients with pulmonary metastatic disease. This study is to enroll patients who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5cm. Patients 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 patients from these treatments such as multiple tumors, multiple previous surgeries, pulmonary dysfunction, or co-morbid medical conditions. For these patients, 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation
Actual Study Start Date : March 2014
Actual Primary Completion Date : August 7, 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Cryoablation
Freezing of the tumor(s)
Device: Cryoablation
All patients will receive cryoablation of up to 6 metastatic lung tumors.
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 [ Time Frame: 12 months post-cryoablation ]

    Measure definitions:

    • Local Tumor Control-defined as the absence of local failure.
    • Complete Response-tumor/ablation zone disappearance or greater than or equal to 75% decrease in the 1 month baseline sum of the three axes of measurements (longest diameter and the two perpendicular diameters).
    • Partial Response-defined as greater than or equal to 30% decrease in the 1 month baseline sum of the three axes of measurements (longest diameter and the two perpendicular diameters).
    • Stable Disease-defined as less than 30% decrease in the 1 month baseline sum of the three axes of measurements (longest diameter and the two perpendicular diameters), and less than 20% increase of the nadir of the 3 axes of measurements.
    • Local Failure-defined as greater than or equal to 20% increase in the sum of the three axes of measurements (longest diameter plus the two perpendicular diameters) when compared with the nadir of this 3 axes measurement.


Secondary Outcome Measures :
  1. Safety assessment [ Time Frame: 30 days post-cryoablation ]
    The safety data for this study will be assessed using the incidence and severity of intra-operative events, post-operative adverse events, serious adverse events and unanticipated adverse device effects related to the cryoablation procedure. No formal hypothesis test is being made on the safety endpoints.


Other Outcome Measures:
  1. Overall patient survival post cryoablation [ Time Frame: 24 months post-cryoablation ]
    Overall survival rate is defined as the time in days from the first cryoablation procedure to death. Patients who are alive will be censored at the date of the last visit. Overall survival rates will be summarized by using Kaplan-Meier methodology.

  2. Time to metastatic lung disease progression beyond the index tumor(s) [ Time Frame: 24 month post-cryoablation ]
    Time to metastatic lung disease progression beyond the index tumor is defined as the time in days from the first cryoablation procedure to metastatic disease beyond the index tumor site. Patients without metastatic lung disease progression will be censored at the date of their last visit or their date of death (due to any cause). Metastatic progression free survival rates will be summarized by using Kaplan-Meier methodology.

  3. Time to overall cancer progression [ Time Frame: 24 months post-cryoablation ]
    •Time to overall cancer progression is defined as the time in days from the first cryoablation procedure to cancer progression (i.e., any location of active cancer disease). Patients without cancer progression will be censored at the date of their last visit or their date of death (due to any cause). Overall cancer progression free survival rates will be summarized by using Kaplan-Meier methodology.

  4. Efficacy of cryoablation on local tumor control for each index tumor [ Time Frame: 18 months post-cryoablation ]
    See definition for the primary outcome.

  5. Efficacy of cryoablation on local tumor control for each index tumor [ Time Frame: 24 months post-cryoablation ]
    See definition for the primary outcome.

  6. Efficacy of cryoablation on local tumor control for each index tumor in patients undergoing additional cryoablation treatment(s) of a previously treated index tumor [ Time Frame: 24 months post-cryoablation ]
    See definition for the primary outcome.

  7. Time to untreatable metastatic lung disease control with cryoablation [ Time Frame: 24 months post-cryoablation ]
    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. Overall time to untreatable metastatic lung disease progression rates will be summarized by using Kaplan-Meier methodology.

  8. Time to untreatable metastatic lung disease control with focal therapy [ Time Frame: 24 months post-cryoablation ]
    Time to untreatable metastatic lung disease control with focal therapy is defined as the time in days from the first cryoablation procedure to the time when the metastatic lung disease cannot be treated by focal (e.g., ablation, surgery, SBRT) intervention for control of metastatic lung disease. Overall time to untreatable metastatic lung disease progression rates will be summarized by using Kaplan-Meier methodology.

  9. Cryoablation technical success [ Time Frame: 1 month post-cryoablation ]
    A technically successful treatment will be defined by the presence of an ablation zone, ground glass opacity, or frank consolidation encompassing the targeted index tumor(s) no later than the 1 month follow up visit after the cryoablation procedure. Technical success will be analyzed on a per tumor basis.

  10. Changes in physical function [ Time Frame: 24 Months ]

    Physical function assessments will be measured using Karnofsky Performance Scale (KPS). The Karnofsky Performance 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 patient is better able to carry out daily activities. KPS may be used to determine a patient's prognosis, to measure changes in a patient's ability to function. Assessments will be made by examining the change in the baseline scores to those reported post-operatively.

    KPS will be assessed at screening and months 1, 3, 6, 12, 18, and 24.


  11. Changes in quality of life over time [ Time Frame: 3 months ]

    This protocol will utilize the Short Form-12 (SF-12) generic measure. The SF-12 is a shortened version of the well-known SF-36. The SF-12 uses twelve items to assess 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, general health perception). The shorter instrument will provide a general measurement of quality of life. Assessments will be made by examining the change in the baseline scores to those reported post-operatively.

    SF-12 will be completed by the patient at screening, month 1 and month 3.




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:

  • Patient must be at least 18 years old.
  • Patient has signed a written informed consent.
  • Patient presents with Stage 4 pulmonary metastatic disease with metastatic disease previously confirmed by prior biopsy; or Patient presents with Stage 4 pulmonary metastatic disease previously confirmed on imaging (e.g. computerized tomography or CT) with histology proven primary cancer.
  • Patient 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/mm3 within 8 weeks prior to initial cryoablation procedure.
  • International Normalized Ratio (INR) less than 1.5 within 8 weeks prior to initial cryoablation procedure.
  • Patient has a life expectancy of greater than 3 months.

Exclusion Criteria:

  • Patient's index tumor(s) is primary lung cancer.
  • Patient has uncontrollable primary or metastatic disease outside of the lung.
  • Patient is unable to lie flat or has respiratory distress at rest.
  • Patient has a coagulopathy or bleeding disorder which is uncontrolled.
  • Absolute Neutrophil Count (ANC) <1000 within 8 weeks prior to initial cryoablation procedure.
  • Patient has evidence of active systemic, pulmonary, or pericardial infection.
  • Patient has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up.
  • Patient is currently participating in other experimental studies that could affect the primary endpoint (e.g. 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
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
Investigators
Study Chair: Thierry de Baere, MD Gustave Roussy, Cancer Campus, Grand Paris
Study Chair: Matthew Callstrom, MD Mayo Clinic

Publications:

Responsible Party: Galil Medical
ClinicalTrials.gov Identifier: NCT01957787     History of Changes
Other Study ID Numbers: CUC13-LNG079
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Galil Medical:
Metastatic lung tumors
Pulmonary metastatic disease

Additional relevant MeSH terms:
Neoplasm Metastasis
Lung Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases