Radiofrequency Ablation of Pulmonary Tumors Response Evaluation

Overview

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

Full Title of Study: “Radiofrequency Ablation of Pulmonary Tumors Response Evaluation: a Prospective, Intention-to-Treat, Multicenter Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2006

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: 1
    • Treatment

Clinical Trial Outcome Measures

Primary Measures

  • technical success
    • Time Frame: immediate
  • complications
    • Time Frame: 30 days
  • pulmonary function
    • Time Frame: 2 years
  • tumor response
    • Time Frame: 1 years

Secondary Measures

  • overall survival
    • Time Frame: 2 years
  • cancer-specific survival
    • Time Frame: 2 years
  • quality of life
    • Time Frame: 2 years

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Angiodynamics, Inc.
  • Provider of Information About this Clinical Study
    • Riccardo Lencioni, University of Pisa, Pisa, Italy
  • Overall Official(s)
    • Riccardo Lencioni, MD, Principal Investigator, University of Pisa, Pisa, Italy

References

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.

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.

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.

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.

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