Safety and Efficacy of Cryoablation for Metastatic Lung Tumors (ECLIPSE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Galil Medical
ClinicalTrials.gov Identifier:
NCT01307501
First received: March 1, 2011
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

ECLIPSE will evaluate the safety and efficacy of cryoablation therapy used to treat tumors less than or equal to 3.5 cm in patients with pulmonary metastatic disease.


Condition Intervention Phase
Metastatic Lung Cancer
Device: Cryoablation
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients - Safety and Efficacy

Resource links provided by NLM:


Further study details as provided by Galil Medical:

Primary Outcome Measures:
  • Local tumor control as measured by imaging [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Measure definitions:

    • Local Control (absence of local failure)
    • Complete Response(tumor disappearance (scar) or less than 25% of original size)
    • Partial Response (greater than 30% decrease in the sum of the largest diameter of all targeted tumors)
    • Stable Disease (less than 30% decrease in the sum of the largest diameter of all targeted tumors)
    • Local Failure (greater than 20% increase in the sum of the largest diameter of all targeted tumors)
    • Distant Failure (the appearance of distant cancer deposits consistent with metastatic spread of cancer outside the intended treatment area)


Secondary Outcome Measures:
  • Overall disease specific survival [ Time Frame: 60 months ] [ Designated as safety issue: No ]
    Survival of these patients will be measured by time in days from cryoablation procedure to death.

  • Time to disease recurrence or progression [ Time Frame: 60 months ] [ Designated as safety issue: No ]
    Disease recurrence or progression will be determined locally by evidence of an increase in tumor size and/or contrast enhancement.

  • Changes in physical function and quality of life over time [ Time Frame: 60 months ] [ Designated as safety issue: No ]
    Physical performance (Eastern Cooperative Oncology Group and Karnofsky Performance Scale) and quality of life (Short Form-12) assessments will be made by examining the change in the baseline scores to those reported postoperatively.

  • Cryoablation technical success [ Time Frame: 60 months ] [ Designated as safety issue: No ]

    A technically successful treatment will be defined by an ablation volume encompassing the tumor with at least a 5 mm margin.

    Technical success will be calculated on a per tumor level as well as a patient level. To be considered a technical success on a patient level all tumors treated during the baseline procedure must meet the technical success criteria.


  • Safety assessment [ Time Frame: 30 days post-cryoablation ] [ Designated as safety issue: Yes ]
    The safety endpoint for this study is to assess 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.


Enrollment: 40
Study Start Date: August 2011
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cryoablation
Freezing of the tumor(s)
Device: Cryoablation
All patients will receive cryoablation of up to 5 metastatic lung tumors bilaterally.
Other Names:
  • 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

Detailed Description:

ECLIPSE is a treatment, Phase 1 multicenter, prospective, single arm study with patients serving as their own control. This study is to enroll patients who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5 cm. Patients will be followed to 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must be at least 18 years old.
  • Patient presents with Stage 4 pulmonary metastatic disease with metastatic disease previously confirmed by prior biopsy or confirmed on imaging with known primary disease.
  • Patient 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 to be in a location where cryoablation is technically achievable.
  • Eastern Cooperative Oncology Group (ECOG) score of 0-2.
  • Karnofsky Performance Scale score ≥60.
  • Platelet count >50,000/mm3.
  • INR less than 1.5.

Exclusion Criteria:

  • Patient's primary cancer is lung cancer.
  • Patient 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.
  • Patient has evidence of active systemic, pulmonary, or pericardial infection.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307501

Locations
United States, California
Ronald Regan UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
France
Institut Gustave Roussy
Villejuif, Cedex, France, 94805
Sponsors and Collaborators
Galil Medical
Investigators
Study Chair: Hiran Fernando, MD Boston Medical Center
  More Information

Publications:
Responsible Party: Galil Medical
ClinicalTrials.gov Identifier: NCT01307501     History of Changes
Other Study ID Numbers: CUC10-LNG06
Study First Received: March 1, 2011
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Galil Medical:
Cryoablation
Cryotherapy
Cryosurgery
Metastatic
Lung
Pleura
Tumors

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014