Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors (FACPT)
Recruitment status was Recruiting
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).
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Prospective Study of Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors|
- Progression-free survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||June 2011|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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)
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.
|Contact: Weiqiang Yin, MD||+86-20-833 email@example.com|
|Contact: Daoyuan Wang, MD||+86-20-833 firstname.lastname@example.org|
|Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College||Recruiting|
|Guangzhou, Guangdong, China, 510120|
|Contact: Jianxing He, MD, FACS +86-20-83337792 email@example.com|
|Contact: Xin Xu, MD +86-20-83337792 firstname.lastname@example.org|
|Principal Investigator: Jianxing He, MD, FACS|
|Principal Investigator:||Jianxing He, MD, FACS||Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College|