Safety and Efficacy of Cryoablation for Metastatic Lung Tumors (ECLIPSE)
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.
|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|
|Estimated Primary Completion Date:||May 2013 (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).
|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|