Clinical trial NCT01957787: Study of Cryoablation for Metastatic Lung Tumors
Official title: Multicenter Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasm Metastasis
Keywords: Metastatic lung tumors
Pulmonary metastatic disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 12
timeFrame: Month 1 (Month 3 if Month 1 Data was missing) and Month 12
Secondary outcomes:
measure: Number of Participants With an Intra- or Post-operative Adverse Event, a Serious Adverse Event, or an Unanticipated Adverse Device Effect
timeFrame: Baseline up to 30 days post-cryoablation
Other outcomes:
measure: Local Tumor Control for Each Index Tumor at Month 18 and Month 24
timeFrame: Month 1 (Month 3 if Month 1 Data was missing), Month 18 and Month 24
measure: Overall Participant Survival Post-cryoablation
timeFrame: Up to Month 24
measure: Time to Metastatic Lung Disease Progression Beyond the Index Tumor(s)
timeFrame: Up to Month 24
measure: Time to Overall Cancer Progression
timeFrame: Up to Month 24
measure: Local Tumor Control With Additional Cryoablation Galil Medical Technology Treatment(s) of a Previously Treated Index Tumor
timeFrame: Up to Month 12
measure: Time to Untreatable Metastatic Lung Disease Control With Cryoablation (Free From Metastatic Lung Disease)
timeFrame: Month 12 (Days 181-365) and Month 24 (Days 495-730)
measure: Time to Untreatable Metastatic Lung Disease Control With Focal Therapy (Free From Metastatic Lung Disease)
timeFrame: Month 12 (Days 181-365) and Month 24 (Days 495-730)
measure: Cryoablation Technical Success at Month 1
timeFrame: Up to Month 1
measure: Change From Baseline in Physical Function as Assessed by the Karnofsky Performance Status (KPS) Scale at Months 1, 3, 6, 12, 18, and 24
timeFrame: Baseline, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24
measure: 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
timeFrame: Baseline, Month 1 and Month 3
Locations:
city: Los Angeles
country: United States
facility: UCLA Ronald Reagan Medical Center
state: California
city: Newnan
country: United States
facility: Cancer Treatment Centers of America at Southeastern Regional Medical Center
state: Georgia
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Cornell Medical Center
state: New York
city: Stony Brook
country: United States
facility: State University of New York at Stony Brook
state: New York
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Alexandria
country: United States
facility: Inova Alexandria Hospital CVIR
state: Virginia
city: Bordeaux
country: France
facility: Institut Bergonié
state: Aquitaine
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Ile-de-France
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Thierry de Baere, MD
role: STUDY_CHAIR
affiliation: Mayo Clinic
name: Matthew Callstrom, MD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.
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.