Radiofrequency Ablation of Pulmonary Tumors Response Evaluation (RAPTURE)
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ClinicalTrials.gov Identifier: NCT00690703 |
Recruitment Status
:
Completed
First Posted
: June 5, 2008
Last Update Posted
: June 5, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Small Cell Lung Cancer Pulmonary Metastases | Device: RF ablation (Rita Medical Systems Model 1500x) | Phase 2 |
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 |

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:
|
- technical success [ Time Frame: immediate ]
- complications [ Time Frame: 30 days ]
- pulmonary function [ Time Frame: 2 years ]
- tumor response [ Time Frame: 1 years ]
- overall survival [ Time Frame: 2 years ]
- cancer-specific survival [ Time Frame: 2 years ]
- quality of life [ Time Frame: 2 years ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690703
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 |
Principal Investigator: | Riccardo Lencioni, MD | University of Pisa, Pisa, Italy |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
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 |