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Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors (FACPT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT01105182
First received: April 12, 2010
Last updated: April 15, 2010
Last verified: December 2009

April 12, 2010
April 15, 2010
November 2009
December 2010   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01105182 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors
A Prospective Study of Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors

The purpose of this study is to assess short and long term outcomes after radiofrequency ablation (RFA) combined with chemotherapy for pulmonary malignancies in patients who are not candidates for surgical resection. This study will evaluate the efficacy of RFA combined with chemotherapy for the treatment of lung tumors by assessing its impact on local tumor control, progression free survival, overall survival, dyspnea score and quality of life (QOL).

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with pulmonary malignancies are not candidates for surgical resectionpatients.

  • NSCLC
  • Pulmonary Metastases
Procedure: Radiofrequency Ablation
Radiofrequency ablation is an inpatient procedure typically requiring one overnight stay in the hospital.
Other Name: WHK-3 RFA (Welfare Electronics Co., Beijing PR China)
Radiofrequency Ablation
Intervention: Procedure: Radiofrequency Ablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
48
June 2011
December 2010   (final data collection date for primary outcome measure)

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 therapy
  • 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 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.

Exclusion Criteria:

  • 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 > 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.
Both
18 Years to 80 Years
No
Contact: Weiqiang Yin, MD +86-20-833 37792 dryin2010@gmail.com
Contact: Daoyuan Wang, MD +86-20-833 37792 ghealth2008@gmail.com
China
 
NCT01105182
FAHG20100201
Yes
The First Affiliated Hospital of Guangzhou Medical College, Guangzhou Medical College
The First Affiliated Hospital of Guangzhou Medical University
Not Provided
Principal Investigator: Jianxing He, MD, FACS Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
The First Affiliated Hospital of Guangzhou Medical University
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP