Radiofrequency Ablation of Pulmonary Tumors Response Evaluation

Non Small Cell Lung Cancer Clinical Trial

— RAPTURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690703
• Other study ID #: 102-00
• Status: Completed
• Phase: Phase 2
• First received: June 3, 2008
• Last updated: June 4, 2008
• Start date: July 2001
• Est. completion date: December 2007

Study information

• Verified date: June 2008
• Source: Angiodynamics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeAustralia: Human Research Ethics CommitteeGermany: Ethics CommissionUnited Kingdom: Research Ethics CommitteeUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer
• Pulmonary Metastases

Intervention

Device:
• RF ablation (Rita Medical Systems Model 1500x)
computed tomography-guided RF ablation with an expandable electrode needle

Locations

Country	Name	City	State
Australia	University of New South Wales	Sydney
Germany	University Hospital Essen	Essen
Germany	Ludwig-Maximilians University	Muenchen
Italy	Institute for Cancer Research and Treatment	Candiolo
Italy	University of Pisa	Pisa
United Kingdom	University College Hospital	London
United States	UCLA Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Angiodynamics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Germany,  Italy,  United Kingdom, 

References & Publications (5)

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. Epub 2005 Jan 21. — View Citation

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. — View Citation

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. Epub 2007 Aug 29. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	technical success		immediate	No
Primary	complications		30 days	Yes
Primary	pulmonary function		2 years	Yes
Primary	tumor response		1 years	No
Secondary	overall survival		2 years	No
Secondary	cancer-specific survival		2 years	No
Secondary	quality of life		2 years	No