Radiofrequency Ablation of Pulmonary Tumors Response Evaluation

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00690703
• Date of registration: 03/06/2008
• Primary sponsor: Angiodynamics, Inc.
• Public title: Radiofrequency Ablation of Pulmonary Tumors Response Evaluation RAPTURE
• Scientific title: Radiofrequency Ablation of Pulmonary Tumors Response Evaluation: a Prospective, Intention-to-Treat, Multicenter Clinical Trial
• Date of first enrolment: July 2001
• Target sample size: 106
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00690703
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Australia, Germany, Italy, United Kingdom, United States

Contacts

• Name: Riccardo Lencioni, MD
• Affiliation: University of Pisa, Pisa, Italy

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Non Small Cell Lung Cancer

Pulmonary Metastases

Intervention(s)

Device: RF ablation (Rita Medical Systems Model 1500x)

Primary Outcome(s)

complications [Time Frame: 30 days]

pulmonary function [Time Frame: 2 years]

technical success [Time Frame: immediate]

tumor response [Time Frame: 1 years]

Secondary Outcome(s)

cancer-specific survival [Time Frame: 2 years]

overall survival [Time Frame: 2 years]

quality of life [Time Frame: 2 years]

Secondary ID(s)

102-00

Source(s) of Monetary Support

Please refer to primary and secondary sponsors