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

Phase 2
18 Years
Not Enrolling
Non Small Cell Lung Cancer, Pulmonary Metastases

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Trial Information

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

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.

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

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

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.

Type of Study:


Study Design:

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

Outcome Measure:

technical success

Outcome Time Frame:


Safety Issue:


Principal Investigator

Riccardo Lencioni, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pisa, Pisa, Italy


Italy: Ethics Committee

Study ID:




Start Date:

July 2001

Completion Date:

December 2007

Related Keywords:

  • Non Small Cell Lung Cancer
  • Pulmonary Metastases
  • non small cell lung cancer
  • pulmonary metastases
  • radiofrequency ablation
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis



UCLA Medical CenterLos Angeles, California  90095-7059