The study hypothesis is that the radiofrequency (RF) ablation is a safe and effective treatment for malignant lung tumors.
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 precluded (1, 2). Recently, RF ablation has been proposed as a viable option for the treatment of pulmonary malignancies. Experimental studies in animal tumor models have confirmed the effectiveness of RF ablation in the destruction of experimentally-induced pulmonary malignancies (3). Pilot clinical investigations have suggested that the treatment can achieve high proportions of tumor response (4, 5). We designed a prospective, intention-to-treat, multicenter clinical trial aimed at assessing feasibility, safety and effectiveness of RF ablation in the treatment of lung malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
106
computed tomography-guided RF ablation with an expandable electrode needle
UCLA Medical Center
Los Angeles, California, United States
University of New South Wales
Sydney, Australia
University Hospital Essen
Essen, Germany
Ludwig-Maximilians University
München, Germany
technical success
Time frame: immediate
complications
Time frame: 30 days
pulmonary function
Time frame: 2 years
tumor response
Time frame: 1 years
overall survival
Time frame: 2 years
cancer-specific survival
Time frame: 2 years
quality of life
Time frame: 2 years
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Institute for Cancer Research and Treatment
Candiolo, Italy
University of Pisa
Pisa, Italy
University College Hospital
London, United Kingdom