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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
Sponsor:
Information provided by:
Angiodynamics, Inc.

Study Description
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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
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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

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Arms and Interventions
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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
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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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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


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
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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