Radiofrequency Ablation of Pulmonary Tumors Response Evaluation (RAPTURE)
Primary Purpose
Non Small Cell Lung Cancer, Pulmonary Metastases
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RF ablation (Rita Medical Systems Model 1500x)
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring non small cell lung cancer, pulmonary metastases, radiofrequency ablation
Eligibility Criteria
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 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.
Exclusion Criteria:
- 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.
Sites / Locations
- UCLA Medical Center
- University of New South Wales
- University Hospital Essen
- Ludwig-Maximilians University
- Institute for Cancer Research and Treatment
- University of Pisa
- University College Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Treatment
Outcomes
Primary Outcome Measures
technical success
complications
pulmonary function
tumor response
Secondary Outcome Measures
overall survival
cancer-specific survival
quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00690703
Brief Title
Radiofrequency Ablation of Pulmonary Tumors Response Evaluation
Acronym
RAPTURE
Official Title
Radiofrequency Ablation of Pulmonary Tumors Response Evaluation: a Prospective, Intention-to-Treat, Multicenter Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Angiodynamics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Pulmonary Metastases
Keywords
non small cell lung cancer, pulmonary metastases, radiofrequency ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Treatment
Intervention Type
Device
Intervention Name(s)
RF ablation (Rita Medical Systems Model 1500x)
Other Intervention Name(s)
Rita Medical Systems Model 1500x, Rita Medical Systems Starburst XL
Intervention Description
computed tomography-guided RF ablation with an expandable electrode needle
Primary Outcome Measure Information:
Title
technical success
Time Frame
immediate
Title
complications
Time Frame
30 days
Title
pulmonary function
Time Frame
2 years
Title
tumor response
Time Frame
1 years
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
2 years
Title
cancer-specific survival
Time Frame
2 years
Title
quality of life
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riccardo Lencioni, MD
Organizational Affiliation
University of Pisa, Pisa, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of New South Wales
City
Sydney
ZIP/Postal Code
NSW 2052
Country
Australia
Facility Name
University Hospital Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Ludwig-Maximilians University
City
Muenchen
ZIP/Postal Code
82152
Country
Germany
Facility Name
Institute for Cancer Research and Treatment
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Facility Name
University of Pisa
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
University College Hospital
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
15665226
Citation
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. doi: 10.1148/radiol.2343040350. Epub 2005 Jan 21.
Results Reference
background
PubMed Identifier
15690326
Citation
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. doi: 10.1002/cncr.20892.
Results Reference
background
PubMed Identifier
11469896
Citation
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. doi: 10.1006/jsre.2001.6208.
Results Reference
background
PubMed Identifier
17903496
Citation
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. doi: 10.1016/j.jtcvs.2007.04.060. Epub 2007 Aug 29.
Results Reference
background
PubMed Identifier
17392258
Citation
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. doi: 10.1148/radiol.2431060088.
Results Reference
background
PubMed Identifier
18565793
Citation
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.
Results Reference
derived
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