Status:
COMPLETED
Radiofrequency Ablation of Pulmonary Tumors Response Evaluation
Lead Sponsor:
Angiodynamics, Inc.
Conditions:
Non Small Cell Lung Cancer
Pulmonary Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The study hypothesis is that the radiofrequency (RF) ablation is a safe and effective treatment for malignant lung tumors.
Detailed Description
Image-guided RF ablation is accepted as a viable therapeutic choice for patients with early-stage hepatocellular carcinoma or limited hepatic metastatic disease from colorectal cancer, when surgery is...
Eligibility Criteria
Inclusion
- adult (\> 18 years) male or female patient
- patient has biopsy-proven NSCLC or lung metastasis
- patient has been rejected for surgery and has been considered unfit for radiation therapy or chemotherapy
- patient has as many as 3 tumors per lung, each 3.5 cm or smaller in greatest diameter, by CT scan
- tumors are located at least 1 cm from trachea; main bronchi; esophagus; aorta; aortic arch branches; pulmonary artery; and heart
- tumors are accessible by percutaneous route
- patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- patient has platelet count \> 100 x 109 /L and international normalized ratio ≤ 1.5
- patient has signed written informed consent prior to any study specific procedures.
Exclusion
- patient has undergone previous pneumonectomy
- patient is considered at high-risk for RF ablation due to major co-morbid medical conditions
- patient has more than 3 tumors / lung
- patient has at least one tumor \> 3.5 in greatest diameter
- tumor is associated with atelectasis or obstructive pneumonitis
- patient has renal failure requiring hemodialysis or peritoneal dialysis
- patient has active clinically serious infection
- patient has history of organ allograft
- patient has history of substance abuse or any medical, psychological or social conditions that may interfere with his / her participation in the study or evaluation of the study results
- patient is pregnant or breast-feeding
- patient has ECOG performance status \> 2
- patient has platelet count ≤ 100 x 109 /L or international normalized ratio \> 1.5.
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00690703
Start Date
July 1 2001
End Date
December 1 2007
Last Update
June 5 2008
Active Locations (7)
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1
UCLA Medical Center
Los Angeles, California, United States, 90095
2
University of New South Wales
Sydney, Australia, NSW 2052
3
University Hospital Essen
Essen, Germany, 45122
4
Ludwig-Maximilians University
München, Germany, 82152