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Radiofrequency Ablation of Pulmonary Tumors Response Evaluation

NCT ID: NCT00690703

Last Updated: 2008-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2007-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Non Small Cell Lung Cancer Pulmonary Metastases

Keywords

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non small cell lung cancer pulmonary metastases radiofrequency ablation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Treatment

Group Type EXPERIMENTAL

RF ablation (Rita Medical Systems Model 1500x)

Intervention Type DEVICE

computed tomography-guided RF ablation with an expandable electrode needle

Interventions

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RF ablation (Rita Medical Systems Model 1500x)

computed tomography-guided RF ablation with an expandable electrode needle

Intervention Type DEVICE

Other Intervention Names

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Rita Medical Systems Model 1500x Rita Medical Systems Starburst XL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Angiodynamics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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University of Pisa, Pisa, Italy

Principal Investigators

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Riccardo Lencioni, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pisa, Pisa, Italy

Locations

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UCLA Medical Center

Los Angeles, California, United States

Site Status

University of New South Wales

Sydney, , Australia

Site Status

University Hospital Essen

Essen, , Germany

Site Status

Ludwig-Maximilians University

München, , Germany

Site Status

Institute for Cancer Research and Treatment

Candiolo, , Italy

Site Status

University of Pisa

Pisa, , Italy

Site Status

University College Hospital

London, , United Kingdom

Site Status

Countries

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United States Australia Germany Italy United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 15665226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15690326 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11469896 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17903496 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17392258 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18565793 (View on PubMed)

Other Identifiers

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102-00

Identifier Type: -

Identifier Source: org_study_id