Radiofrequency Ablation of Pulmonary Tumors Response Evaluation (RAPTURE)

Radiofrequency Ablation of Pulmonary Tumors Response Evaluation: a Prospective, Intention-to-Treat, Multicenter Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Metastases; Non Small Cell Lung Cancer
• Intervention / Treatment: Device: RF ablation (Rita Medical Systems Model 1500x)

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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
complications	30 days
technical success	immediate
pulmonary function	2 years
tumor response	1 years

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	2 years
quality of life	2 years
cancer-specific survival	2 years

Collaborators and Investigators

• Sponsor: Angiodynamics, Inc.
• Investigators: Principal Investigator: Riccardo Lencioni, MD, University of Pisa, Pisa, Italy

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2001
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: June 3, 2008
• First Submitted That Met QC Criteria: June 4, 2008
• First Posted (Estimate): June 5, 2008

Study Record Updates

• Last Update Posted (Estimate): June 5, 2008
• Last Update Submitted That Met QC Criteria: June 4, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: radiofrequency ablation; non small cell lung cancer; pulmonary metastases
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplastic Processes; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis
• Other Study ID Numbers: 102-00