Radiofrequency Ablation of Pulmonary Tumors Response Evaluation

NCT00690703 | Completed Phase 2

• 1 other identifier: 102-00
• Study Type: interventional
• Target: 106
• Locations: 5 countries
• Sites: 7

Brief Summary

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

Conditions

Non Small Cell Lung Cancer; Pulmonary Metastases

Keywords

non small cell lung cancer; pulmonary metastases; radiofrequency ablation

Outcome Measures

Primary Outcomes (4)

• technical success

  immediate

• complications

  30 days

• pulmonary function

  2 years

• tumor response

  1 years

Secondary Outcomes (3)

• overall survival

  2 years

• cancer-specific survival

  2 years

• quality of life

  2 years

Study Arms (1)

1

EXPERIMENTAL

Treatment

Device: RF ablation (Rita Medical Systems Model 1500x)

Interventions

RF ablation (Rita Medical Systems Model 1500x) DEVICE

computed tomography-guided RF ablation with an expandable electrode needle

Also known as: Rita Medical Systems Model 1500x, Rita Medical Systems Starburst XL

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Angiodynamics, Inc.: lead

Study Sites (7)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

University of New South Wales

Sydney, NSW 2052, Australia

Location

University Hospital Essen

Essen, 45122, Germany

Location

Ludwig-Maximilians University

München, 82152, Germany

Location

Institute for Cancer Research and Treatment

Candiolo, 10060, Italy

Location

University of Pisa

Pisa, 56100, Italy

Location

University College Hospital

London, NW1 2BU, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 15665226 BACKGROUND

• 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.

  PMID: 15690326 BACKGROUND

• 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.

  PMID: 11469896 BACKGROUND

• 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.

  PMID: 17903496 BACKGROUND

• 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.

  PMID: 17392258 BACKGROUND

• 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.

  PMID: 18565793 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Riccardo Lencioni, MD

  University of Pisa, Pisa, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 5, 2008
• Study Start: July 1, 2001
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2007
• Last Updated: June 5, 2008

Record last verified: 2008-06

Locations

AU (1); IT (2); GB (1); DE (2); US (1)