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Trial Title:
Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors
NCT ID:
NCT01105182
Condition:
NSCLC
Pulmonary Metastases
Conditions: Official terms:
Neoplasm Metastasis
Conditions: Keywords:
Radiofrequency Ablation
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Radiofrequency Ablation
Description:
Radiofrequency ablation is an inpatient procedure typically requiring one overnight stay
in the hospital.
Arm group label:
Radiofrequency Ablation
Other name:
WHK-3 RFA (Welfare Electronics Co., Beijing PR China)
Summary:
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).
Detailed description:
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.
Criteria for eligibility:
Study pop:
Patients with pulmonary malignancies are not candidates for surgical resectionpatients.
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianxing He, MD, FACS
Phone:
+86-20-83337792
Email:
drjianxing.he@gmail.com
Contact backup:
Last name:
Xin Xu, MD
Phone:
+86-20-83337792
Email:
yichunrenjia@126.com
Investigator:
Last name:
Jianxing He, MD, FACS
Email:
Principal Investigator
Start date:
November 2009
Completion date:
June 2011
Lead sponsor:
Agency:
The First Affiliated Hospital of Guangzhou Medical University
Agency class:
Other
Source:
The First Affiliated Hospital of Guangzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01105182
