Safety and Efficacy of Cryoablation for Metastatic Lung Tumors

NCT01307501 | Completed Results DMC FDA Device

• 1 other identifier: CUC10-LNG06
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 4

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.

Conditions

Metastatic Lung Cancer

Keywords

Cryoablation; Cryotherapy; Cryosurgery; Metastatic; Lung; Pleura; Tumors

Outcome Measures

Primary Outcomes (1)

• Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 60

  Local tumor control was achieved if either the greatest trans-axial diameter of a treated tumor was ≤20% greater than at the pre-procedure assessment (per-tumor assessment) or if the sum of greatest trans-axial diameters of all treated tumors for a participant was ≤20% greater than the sum for the pre-procedure assessment of those tumors (per-participant assessment). Complete Response defined as tumor disappearance (scar) or \<25% of original size. If tumor/ablation zone had likely disappeared, the measurement was recorded as 0 mm; if tumor/ablation zone was present but too small to measure, the measurement was recorded as 5 mm. Partial Response defined as greater than 30% decrease in sum of the largest diameter of all targeted tumors. Stable Disease defined as less than 30% decrease in sum of the largest diameter of all targeted tumors. Local Failure defined as greater than 20% increase in the sum of the largest diameter of all targeted tumors. Worst response per participant was used.

  Baseline and Month 60

Secondary Outcomes (9)

• Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48

  Baseline and Months 3, 6, 12, 24, 36, and 48

• Overall Disease-Specific Participant Survival Post-Cryoablation

  Up to Month 60

• Time in Days to Disease Recurrence or Progression Following Study Cryoablation

  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)

• Change From Baseline in ECOG Performance Status at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60

  Baseline, Week 1 and Months 3, 6, 12, 24, 36, 48, and 60

• 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

  Baseline, Week 1 and Months 3, 6, 12, 24, 36, 48, and 60

Study Arms (1)

Cryoablation

OTHER

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. No more than 3 tumors in 1 lung can be treated in a single session, and no more than 5 total lung tumors (across both lungs) can be treated during the study.

Device: Cryoablation

Interventions

Cryoablation DEVICE

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

Also known as: Visual-ICE® Cryoablation System, PresIce® Cryoablation System, SeedNet® Cryoablation System, IceRod® Cryoablation Needles, IceRod® PLUS Cryoablation Needles, IceSphere™ Cryoablation Needles, IceSeed™ Cryoablation Needles, IceEDGE™ 2.4 Cryoablation Needles

Cryoablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (4)

Ronald Regan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Institut Gustave Roussy

Villejuif, Cedex, 94805, France

Location

Related Publications (7)

• 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.

  PMID: 18442957 BACKGROUND

• 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.

  PMID: 16714662 BACKGROUND

• 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.

  PMID: 15947313 BACKGROUND

• 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.

  PMID: 16678583 BACKGROUND

• 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.

  PMID: 15798173 BACKGROUND

• 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.

  PMID: 16809741 BACKGROUND

• 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.

  PMID: 8628042 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm Metastasis; Neoplasms

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Sr. Clinical Trial Specialist
• Organization: Galil Medical, a wholly owned indirect subsidiary of Boston Scientific

GalilClinical@bsci.com

651-287-5000

Study Officials

• Hiran Fernando, MD

  Boston Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants received the same treatment.

Study Record Dates

• First Submitted: March 1, 2011
• First Posted: March 3, 2011
• Study Start: January 4, 2012
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: July 19, 2021
• Results First Posted: October 1, 2019

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); FR (1)