Status:
UNKNOWN
Video-assisted Thoracoscopic Surgery for Stage IIIA Non-Small Cell Lung Cancer
Lead Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to examine the feasibility of video-assisted thoracoscopic surgery (VATS) major pulmonary resection with systematic node dissection (SND) for clinical stage IIIA non-small...
Detailed Description
Video-assisted or minimally invasive surgery has become the standard approach for many abdominal surgical operations such as cholecystectomy and fundoplication. With respect to the thorax, video-assis...
Eligibility Criteria
Inclusion
- Histologically confirmed non-small cell lung cancer (Squamous, adenosquamous, large cell, or poorly differentiated)
- Stage IIIA (T1-3, N2, M0): N2 disease confirmed by any of the following: Mediastinoscopy; Bronchoscopy with fine-needle aspiration or esophagoscopy; or PET scan
- ECOG performance status 0-1
- Hematopoietic: WBC at least 4,000/mm\^3; Platelet count at least 100,000/mm\^3
- Hepatic: Bilirubin normal; AST/ALT no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 2.5 times ULN
- Renal: Creatinine clearance greater than 60 ml/min
- Cardiovascular: Cardiac function normal
Exclusion
- Severe complications or infections
- Pregnant or breast-feeding women
- Clinically significant heart disease
- Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus
- Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00862004
Start Date
December 1 2008
End Date
December 1 2009
Last Update
February 2 2010
Active Locations (1)
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1
Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China, 510120