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A Prospective Study of Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors

18 Years
80 Years
Open (Enrolling)
NSCLC, Pulmonary Metastases

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Trial Information

A Prospective Study of Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors

Percutaneous image-guided RFA is a minimally invasive technique used to treat solid tumours.
Because of its ability to produce large volumes of coagulation necrosis in a controlled
fashion, this technique has gained acceptance as a viable therapeutic option for
unresectable liver malignancies. Recently, RFA has been proposed as a viable option for the
treatment of pulmonary malignancies. Experimental studies in animal tumor models have
confirmed the effectiveness of RFA in the destruction of experimentally-induced pulmonary
malignancies. Pilot clinical investigations have suggested that the treatment can achieve
high proportions of tumor response. We designed a prospective clinical trial aimed at
assessing feasibility, safety and effectiveness of RFA combined with chemotherapy in the
treatment of lung malignancies.

Inclusion Criteria:

- 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

- each 6 cm or smaller in greatest diameter of tumor, 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

- 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.

Exclusion Criteria:

- patient is considered at high-risk for RF ablation due to major co-morbid medical

- patient has more than 3 tumors / lung

- patient has at least one tumor > 6 cm 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.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Progression-free survival

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Jianxing He, MD, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College


China: Food and Drug Administration

Study ID:




Start Date:

November 2009

Completion Date:

June 2011

Related Keywords:

  • Pulmonary Metastases
  • Radiofrequency Ablation
  • Neoplasm Metastasis
  • Lung Neoplasms