Clinical Trial: Safety and Efficacy of Cryoablation for Metastatic Lung Tumors

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients - Safety and Efficacy

Brief Summary: 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.

Detailed Summary:

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).


Sponsor: Galil Medical

Current Primary Outcome: Local tumor control as measured by imaging [ Time Frame: 12 months ]

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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall disease specific survival [ Time Frame: 60 months ]
    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 ]
    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 ]
    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 ]

    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 ]
    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.


Original Secondary Outcome: Same as current

Information By: Galil Medical

Dates:
Date Received: March 1, 2011
Date Started: August 2011
Date Completion: June 2019
Last Updated: May 8, 2017
Last Verified: May 2017