Non Small Cell Lung Cancer, Pulmonary Metastases
Conditions
Keywords
non small cell lung cancer, pulmonary metastases, radiofrequency ablation
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.
Interventions
DEVICERF ablation (Rita Medical Systems Model 1500x)
computed tomography-guided RF ablation with an expandable electrode needle
Sponsors
Angiodynamics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. adult (\> 18 years) male or female patient 2. patient has biopsy-proven NSCLC or lung metastasis 3. patient has been rejected for surgery and has been considered unfit for radiation therapy or chemotherapy 4. patient has as many as 3 tumors per lung, each 3.5 cm or smaller in greatest diameter, by CT scan 5. tumors are located at least 1 cm from trachea; main bronchi; esophagus; aorta; aortic arch branches; pulmonary artery; and heart 6. tumors are accessible by percutaneous route 7. patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 8. patient has platelet count \> 100 x 109 /L and international normalized ratio ≤ 1.5 9. patient has signed written informed consent prior to any study specific procedures.
Exclusion criteria
1. patient has undergone previous pneumonectomy 2. patient is considered at high-risk for RF ablation due to major co-morbid medical conditions 3. patient has more than 3 tumors / lung 4. patient has at least one tumor \> 3.5 in greatest diameter 5. tumor is associated with atelectasis or obstructive pneumonitis 6. patient has renal failure requiring hemodialysis or peritoneal dialysis 7. patient has active clinically serious infection 8. patient has history of organ allograft 9. 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 10. patient is pregnant or breast-feeding 11. patient has ECOG performance status \> 2 12. patient has platelet count ≤ 100 x 109 /L or international normalized ratio \> 1.5.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| technical success | immediate |
| complications | 30 days |
| pulmonary function | 2 years |
| tumor response | 1 years |
Secondary
| Measure | Time frame |
|---|---|
| cancer-specific survival | 2 years |
| quality of life | 2 years |
| overall survival | 2 years |
Countries
Australia, Germany, Italy, United Kingdom, United States
Outcome results
None listed