Radiofrequency Ablation of Pulmonary Tumors Response Evaluation (RAPTURE)

This study has been completed.
Sponsor:
Information provided by:
Angiodynamics, Inc.
ClinicalTrials.gov Identifier:
NCT00690703
First received: June 3, 2008
Last updated: June 4, 2008
Last verified: June 2008
  Purpose

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


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation of Pulmonary Tumors Response Evaluation: a Prospective, Intention-to-Treat, Multicenter Clinical Trial

Resource links provided by NLM:


Further study details as provided by Angiodynamics, Inc.:

Primary Outcome Measures:
  • technical success [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • pulmonary function [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • tumor response [ Time Frame: 1 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • cancer-specific survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: July 2001
Study Completion Date: December 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:
Additional 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
Study First Received: June 3, 2008
Last Updated: June 4, 2008
Health Authority: Italy: Ethics Committee
Australia: Human Research Ethics Committee
Germany: Ethics Commission
United Kingdom: Research Ethics Committee
United States: Institutional Review Board

Keywords provided by Angiodynamics, Inc.:
non small cell lung cancer
pulmonary metastases
radiofrequency ablation

Additional relevant MeSH terms:
Neoplasm Metastasis
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014