Clinical trial NCT01307501: Safety and Efficacy of Cryoablation for Metastatic Lung Tumors
Official title: Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients - Safety and Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Lung Cancer
Keywords: Cryoablation
Cryotherapy
Cryosurgery
Metastatic
Lung
Pleura
Tumors
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2011-03-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants received the same treatment.
Primary purpose: TREATMENT

Brief summary: ECLIPSE will evaluate the safety and efficacy of cryoablation therapy used to treat tumors less than or equal to 3.5 centimeters (cm) in participants with pulmonary metastatic disease.

Detailed description: ECLIPSE is a treatment, Phase 1 multicenter, prospective, single-arm study with participants serving as their own control. 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 cm. Participants will be followed for 5 years post their cryoablation procedure.

Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal), and urology (kidney).

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 confirmed on imaging with known primary disease.
* Participant has up to 3 local metastases unilaterally targeted by cryoablation. Maximum of 5 total pulmonary tumors bilaterally.
* Targeted tumor(s) defined as intra pulmonary or pleural with a maximum size of 3.5 cm.
* The target tumor is determined (by CT/MRI) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs and structures.
* Eastern Cooperative Oncology Group (ECOG) score of 0-2.
* Karnofsky Performance Scale (KPS) score ≥60.
* Platelet count \>50,000/cubed millimeters (mm\^3) within 60 days prior to study treatment.
* International normalized ratio (INR) less than 1.5 within 60 days prior to study treatment.
* Participant has a life expectancy of \>3 months.
* Participant is clinically suitable for cryoablation procedure.

Exclusion Criteria:

* Participant's primary cancer is lung cancer.
* Participant is unable to lie flat or has respiratory distress at rest.
* Participant has uncontrolled coagulopathy or bleeding disorders.
* Participant has had chemotherapy with neutropenia to levels as confirmed by absolute neutrophil count (ANC) of less than 1000 that produce increase risk for the cryoablation procedure.
* Participant has a history of an allergic reaction to iodine injections or to shellfish.
* 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.

Primary outcomes:
measure: Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 60
timeFrame: Baseline and Month 60
Secondary outcomes:
measure: Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
timeFrame: Baseline and Months 3, 6, 12, 24, 36, and 48
measure: Overall Disease-Specific Participant Survival Post-Cryoablation
timeFrame: Up to Month 60
measure: Time in Days to Disease Recurrence or Progression Following Study Cryoablation
timeFrame: Baseline (0 days), Week 1 (7 days), and Months 3 (90 days), 6 (180 days), 12 (365 days), 24 (730 days), 36 (1095 days), 48 (1460 days), and 60 (1825 days)
measure: Change From Baseline in ECOG Performance Status at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
timeFrame: Baseline, Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
measure: Change From Baseline in Physical Function as Assessed by the KPS Scale at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
timeFrame: Baseline, Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
measure: Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
timeFrame: Baseline, Months 1, 3, 6, 12, 24, 36, 48, and 60
measure: Cryoablation Technical Success of the Study Cryoablation Procedure
timeFrame: Up to 60 months
measure: Number of Participants With an Intra- or Post-operative Adverse Event (AE), a Serious AE, or an Unanticipated Adverse Device Effect (UADE)
timeFrame: Baseline up to 30 days post-cryoablation
measure: Metastatic Disease Spread as Measured by Imaging
timeFrame: Months 3, 6, 12, 24, 36, 48, and 60
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Regan UCLA Medical Center
state: California
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Cedex
Study officials:
affiliation: Boston Medical Center
name: Hiran Fernando, 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: 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: 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: 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: Blazeby JM, Avery K, Sprangers M, Pikhart H, Fayers P, Donovan J. Health-related quality of life measurement in randomized clinical trials in surgical oncology. J Clin Oncol. 2006 Jul 1;24(19):3178-86. doi: 10.1200/JCO.2005.05.2951.
citation: Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.