Safety and Efficacy of Cryoablation for Metastatic Lung Tumors (ECLIPSE)
|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|
- Local tumor control as measured by imaging [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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)
- 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.
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||May 2017|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Freezing of the tumor(s)
All patients will receive cryoablation of up to 5 metastatic lung tumors bilaterally.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307501
|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|
|Institut Gustave Roussy|
|Villejuif, Cedex, France, 94805|
|Study Chair:||Hiran Fernando, MD||Boston Medical Center|