Radiofrequency Ablation of Pulmonary Tumors Response Evaluation

Study Overview
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Brief Summary
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The study hypothesis is that the radiofrequency (RF) ablation is a safe and effective treatment for malignant lung tumors.

Detailed Description
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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.

Official Title
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Radiofrequency Ablation of Pulmonary Tumors Response Evaluation: a Prospective, Intention-to-Treat, Multicenter Clinical Trial

Conditions
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Non Small Cell Lung Cancer, Pulmonary Metastases

Intervention / Treatment
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* Device: RF ablation (Rita Medical Systems Model 1500x)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Treatment | Device: RF ablation (Rita Medical Systems Model 1500x)<br>* computed tomography-guided RF ablation with an expandable electrode needle<br>* Other names: Rita Medical Systems Starburst XL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| technical success |  | immediate | 
| complications |  | 30 days | 
| pulmonary function |  | 2 years | 
| tumor response |  | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 2 years | 
| cancer-specific survival |  | 2 years | 
| quality of life |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non small cell lung cancer, pulmonary metastases, radiofrequency ablation