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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Metastatic Lung Cancer

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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 InstituteDetroit, Michigan  48201
Mayo Clinic RochesterRochester, Minnesota  55905
Ronald Regan UCLA Medical CenterLos Angeles, California  90095