Radiofrequency Ablation of Pulmonary Tumors Response Evaluation

Completed · Phase 2

Conditions studied: Non Small Cell Lung Cancer, Pulmonary Metastases

In brief

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

Key facts

Study ID

NCT00690703

Run by

Angiodynamics, Inc.

People needed

106

Starts

2001-07-01

Expected to finish

2007-12-01

Last updated by the study team

2008-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Institute for Cancer Research and Treatment — Candiolo, Italy
• University of Pisa — Pisa, Italy
• University College Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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