Radiofrequency Ablation of Pulmonary Tumors Response Evaluation

Phase 2

Completed

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 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.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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.

Arm && Interventions

Group	Intervention	Description
1	RF ablation (Rita Medical Systems Model 1500x)	Treatment

Primary Outcome Measures

Secondary Outcome Measures

Locations (7): UCLA Medical Center
🇺🇸
Los Angeles, California, United States
University of New South Wales
🇦🇺
Sydney, Australia
University Hospital Essen
🇩🇪
Essen, Germany
University of Pisa
🇮🇹
Pisa, Italy
University College Hospital
🇬🇧
London, United Kingdom
Institute for Cancer Research and Treatment
🇮🇹
Candiolo, Italy
Ludwig-Maximilians University
🇩🇪
Muenchen, Germany

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