Safety and Efficacy of Cryoablation for Metastatic Lung Tumors (ECLIPSE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01307501|
Recruitment Status : Active, not recruiting
First Posted : March 3, 2011
Last Update Posted : August 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Lung Cancer||Device: Cryoablation||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants received the same treatment.|
|Masking:||None (Open Label)|
|Official Title:||Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients - Safety and Efficacy|
|Actual Study Start Date :||August 2011|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
Freezing of the tumor(s)
All patients will receive cryoablation of up to 5 metastatic lung tumors bilaterally.
- Local tumor control as measured by imaging [ Time Frame: 60 months ]
Measure definitions (all measured by number of tumors):
- 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)
- Metastatic disease spread as measured by imaging [ Time Frame: 60 months ]
Measure definition (measured by number of patients):
-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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|