Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients - Safety and Efficacy
18 Years
N/A
Both
Metastatic Lung Cancer
Trial Information
Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients - Safety and Efficacy
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).
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Local tumor control as measured by imaging
Outcome Description:
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)
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Hiran Fernando, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Boston Medical Center
Authority:
United States: Institutional Review Board
Study ID:
CUC10-LNG06
NCT ID:
NCT01307501
Start Date:
August 2011
Completion Date:
May 2017
Related Keywords:
- Metastatic Lung Cancer
- Cryoablation
- Cryotherapy
- Cryosurgery
- Metastatic
- Lung
- Pleura
- Tumors
- Lung Neoplasms
Name | Location |
|---|---|
| Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Mayo Clinic Rochester | Rochester, Minnesota 55905 |
| Ronald Regan UCLA Medical Center | Los Angeles, California 90095 |
