Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors (FACPT)

Patients with pulmonary malignancies are not candidates for surgical resectionpatients.

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
• each 6 cm or smaller in greatest diameter of tumor, 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 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 > 6 cm 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.