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Study of Cryoablation for Metastatic Lung Tumors (SOLSTICE)

Primary Purpose

Neoplasm Metastasis

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Cryoablation

About this trial

This is an interventional treatment trial for Neoplasm Metastasis focused on measuring Metastatic lung tumors, Pulmonary metastatic disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

UCLA Ronald Reagan Medical Center
Cancer Treatment Centers of America at Southeastern Regional Medical Center
Mayo Clinic Rochester
Memorial Sloan Kettering Cancer Center
New York Presbyterian Hospital - Cornell Medical Center
State University of New York at Stony Brook
Rhode Island Hospital
Inova Alexandria Hospital CVIR
Institut Bergonié
Institut Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cryoablation

Arm Description

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.

Outcomes

Primary Outcome Measures

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

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

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.

Full Information

NCT ID

NCT01957787

First Posted

October 4, 2013

Last Updated

July 15, 2021

Sponsor

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01957787

Brief Title

Study of Cryoablation for Metastatic Lung Tumors

Acronym

SOLSTICE

Official Title

Multicenter Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

April 10, 2014 (Actual)

Primary Completion Date

March 9, 2017 (Actual)

Study Completion Date

August 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston Scientific Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplasm Metastasis

Keywords

Metastatic lung tumors, Pulmonary metastatic disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

131 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cryoablation

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Cryoablation

Other Intervention Name(s)

Cryotherapy, Visual-ICE® Cryoablation System, PresIce® Cryoablation System, SeedNet® Cryoablation System, IceEDGE® 2.4 Cryoablation Needles, IceRod® PLUS Cryoablation Needles, IceSphere™ Cryoablation Needles

Intervention Description

Application of extremely cold temperatures to the identified tumor(s).

Primary Outcome Measure Information:

Title

Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 12

Description

Time Frame

Month 1 (Month 3 if Month 1 Data was missing) and Month 12

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline up to 30 days post-cryoablation

Other Pre-specified Outcome Measures:

Title

Local Tumor Control for Each Index Tumor at Month 18 and Month 24

Description

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.

Time Frame

Month 1 (Month 3 if Month 1 Data was missing), Month 18 and Month 24

Title

Overall Participant Survival Post-cryoablation

Description

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.

Time Frame

Up to Month 24

Title

Time to Metastatic Lung Disease Progression Beyond the Index Tumor(s)

Description

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).

Time Frame

Up to Month 24

Title

Time to Overall Cancer Progression

Description

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).

Time Frame

Up to Month 24

Title

Local Tumor Control With Additional Cryoablation Galil Medical Technology Treatment(s) of a Previously Treated Index Tumor

Description

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.

Time Frame

Up to Month 12

Title

Time to Untreatable Metastatic Lung Disease Control With Cryoablation (Free From Metastatic Lung Disease)

Description

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.

Time Frame

Month 12 (Days 181-365) and Month 24 (Days 495-730)

Title

Time to Untreatable Metastatic Lung Disease Control With Focal Therapy (Free From Metastatic Lung Disease)

Description

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.

Time Frame

Month 12 (Days 181-365) and Month 24 (Days 495-730)

Title

Cryoablation Technical Success at Month 1

Description

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.

Time Frame

Up to Month 1

Title

Change From Baseline in Physical Function as Assessed by the Karnofsky Performance Status (KPS) Scale at Months 1, 3, 6, 12, 18, and 24

Description

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.

Time Frame

Baseline, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24

Title

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

Description

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.

Time Frame

Baseline, Month 1 and Month 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thierry de Baere, MD

Organizational Affiliation

Gustave Roussy, Cancer Campus, Grand Paris

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Matthew Callstrom, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Study Chair

Facility Information:

Facility Name

UCLA Ronald Reagan Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Cancer Treatment Centers of America at Southeastern Regional Medical Center

City

Newnan

State/Province

Georgia

ZIP/Postal Code

30265

Country

United States

Facility Name

Mayo Clinic Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

New York Presbyterian Hospital - Cornell Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

State University of New York at Stony Brook

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794

Country

United States

Facility Name

Rhode Island Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

Inova Alexandria Hospital CVIR

City

Alexandria

State/Province

Virginia

ZIP/Postal Code

22304

Country

United States

Facility Name

Institut Bergonié

City

Bordeaux

State/Province

Aquitaine

ZIP/Postal Code

33070

Country

France

Facility Name

Institut Gustave Roussy

City

Villejuif

State/Province

Ile-de-France

ZIP/Postal Code

94805

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

18442957

Citation

Gillams A. Lung tumour ablation - where are we now? Cancer Imaging. 2008 Apr 22;8(1):116-7. doi: 10.1102/1470-7330.2008.0015.

Results Reference

background

PubMed Identifier

16714662

Citation

Ahmed A, Littrup P. Percutaneous cryotherapy of the thorax: safety considerations for complex cases. AJR Am J Roentgenol. 2006 Jun;186(6):1703-6. doi: 10.2214/AJR.04.1068. No abstract available.

Results Reference

background

PubMed Identifier

16678583

Citation

Kawamura M, Izumi Y, Tsukada N, Asakura K, Sugiura H, Yashiro H, Nakano K, Nakatsuka S, Kuribayashi S, Kobayashi K. Percutaneous cryoablation of small pulmonary malignant tumors under computed tomographic guidance with local anesthesia for nonsurgical candidates. J Thorac Cardiovasc Surg. 2006 May;131(5):1007-13. doi: 10.1016/j.jtcvs.2005.12.051.

Results Reference

background

PubMed Identifier

15947313

Citation

Asimakopoulos G, Beeson J, Evans J, Maiwand MO. Cryosurgery for malignant endobronchial tumors: analysis of outcome. Chest. 2005 Jun;127(6):2007-14. doi: 10.1378/chest.127.6.2007.

Results Reference

background

PubMed Identifier

15798173

Citation

Wang H, Littrup PJ, Duan Y, Zhang Y, Feng H, Nie Z. Thoracic masses treated with percutaneous cryotherapy: initial experience with more than 200 procedures. Radiology. 2005 Apr;235(1):289-98. doi: 10.1148/radiol.2351030747.

Results Reference

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PubMed Identifier

22265246

Citation

Inoue M, Nakatsuka S, Yashiro H, Ito N, Izumi Y, Yamauchi Y, Hashimoto K, Asakura K, Tsukada N, Kawamura M, Nomori H, Kuribayashi S. Percutaneous cryoablation of lung tumors: feasibility and safety. J Vasc Interv Radiol. 2012 Mar;23(3):295-302; quiz 305. doi: 10.1016/j.jvir.2011.11.019. Epub 2012 Jan 20.

Results Reference

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PubMed Identifier

22096520

Citation

Yamauchi Y, Izumi Y, Kawamura M, Nakatsuka S, Yashiro H, Tsukada N, Inoue M, Asakura K, Nomori H. Percutaneous cryoablation of pulmonary metastases from colorectal cancer. PLoS One. 2011;6(11):e27086. doi: 10.1371/journal.pone.0027086. Epub 2011 Nov 9.

Results Reference

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PubMed Identifier

23394762

Citation

Pusceddu C, Sotgia B, Fele RM, Melis L. CT-guided thin needles percutaneous cryoablation (PCA) in patients with primary and secondary lung tumors: a preliminary experience. Eur J Radiol. 2013 May;82(5):e246-53. doi: 10.1016/j.ejrad.2012.12.010. Epub 2013 Feb 8.

Results Reference

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Study of Cryoablation for Metastatic Lung Tumors

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