Radiofrequency Ablation of Pulmonary Tumors Response Evaluation (RAPTURE)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Non Small Cell Lung Cancer; Pulmonary Metastases	Device: RF ablation (Rita Medical Systems Model 1500x)	Phase 2

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.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	106 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Radiofrequency Ablation of Pulmonary Tumors Response Evaluation: a Prospective, Intention-to-Treat, Multicenter Clinical Trial
Study Start Date :	July 2001
Actual Primary Completion Date :	December 2006
Actual Study Completion Date :	December 2007

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; Treatment	Device: RF ablation (Rita Medical Systems Model 1500x); computed tomography-guided RF ablation with an expandable electrode needle; Other Names: Rita Medical Systems Model 1500x; Rita Medical Systems Starburst XL

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. technical success [ Time Frame: immediate ]
2. complications [ Time Frame: 30 days ]
3. pulmonary function [ Time Frame: 2 years ]
4. tumor response [ Time Frame: 1 years ]

Secondary Outcome Measures :

1. overall survival [ Time Frame: 2 years ]
2. cancer-specific survival [ Time Frame: 2 years ]
3. quality of life [ Time Frame: 2 years ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
Australia
University of New South Wales
Sydney, Australia, NSW 2052
Germany
University Hospital Essen
Essen, Germany, 45122
Ludwig-Maximilians University
Muenchen, Germany, 82152
Italy
Institute for Cancer Research and Treatment
Candiolo, Italy, 10060
University of Pisa
Pisa, Italy, 56100
United Kingdom
University College Hospital
London, United Kingdom, NW1 2BU

Sponsors and Collaborators

Angiodynamics, Inc.

Investigators

Principal Investigator:	Riccardo Lencioni, MD	University of Pisa, Pisa, Italy

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Lencioni R, Cioni D, Crocetti L, Franchini C, Pina CD, Lera J, Bartolozzi C. Early-stage hepatocellular carcinoma in patients with cirrhosis: long-term results of percutaneous image-guided radiofrequency ablation. Radiology. 2005 Mar;234(3):961-7. Epub 2005 Jan 21.

Tateishi R, Shiina S, Teratani T, Obi S, Sato S, Koike Y, Fujishima T, Yoshida H, Kawabe T, Omata M. Percutaneous radiofrequency ablation for hepatocellular carcinoma. An analysis of 1000 cases. Cancer. 2005 Mar 15;103(6):1201-9.

Miao Y, Ni Y, Bosmans H, Yu J, Vaninbroukx J, Dymarkowski S, Zhang H, Marchal G. Radiofrequency ablation for eradication of pulmonary tumor in rabbits. J Surg Res. 2001 Aug;99(2):265-71.

Pennathur A, Luketich JD, Abbas G, Chen M, Fernando HC, Gooding WE, Schuchert MJ, Gilbert S, Christie NA, Landreneau RJ. Radiofrequency ablation for the treatment of stage I non-small cell lung cancer in high-risk patients. J Thorac Cardiovasc Surg. 2007 Oct;134(4):857-64. Epub 2007 Aug 29.

Simon CJ, Dupuy DE, DiPetrillo TA, Safran HP, Grieco CA, Ng T, Mayo-Smith WW. Pulmonary radiofrequency ablation: long-term safety and efficacy in 153 patients. Radiology. 2007 Apr;243(1):268-75.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lencioni R, Crocetti L, Cioni R, Suh R, Glenn D, Regge D, Helmberger T, Gillams AR, Frilling A, Ambrogi M, Bartolozzi C, Mussi A. Response to radiofrequency ablation of pulmonary tumours: a prospective, intention-to-treat, multicentre clinical trial (the RAPTURE study). Lancet Oncol. 2008 Jul;9(7):621-8. doi: 10.1016/S1470-2045(08)70155-4. Epub 2008 Jun 17.

Responsible Party:	Riccardo Lencioni, University of Pisa, Pisa, Italy
ClinicalTrials.gov Identifier:	NCT00690703 History of Changes
Other Study ID Numbers:	102-00
First Posted:	June 5, 2008
Last Update Posted:	June 5, 2008
Last Verified:	June 2008

Keywords provided by Angiodynamics, Inc.:

non small cell lung cancer; pulmonary metastases; radiofrequency ablation

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms	Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes