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Video-assisted Thoracoscopic Surgery for Stage IIIA Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00862004
Recruitment Status : Unknown
Verified March 2009 by The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was:  Recruiting
First Posted : March 16, 2009
Last Update Posted : February 2, 2010
Sponsor:
Information provided by:
The First Affiliated Hospital of Guangzhou Medical University

Tracking Information
First Submitted Date  ICMJE March 13, 2009
First Posted Date  ICMJE March 16, 2009
Last Update Posted Date February 2, 2010
Study Start Date  ICMJE December 2008
Estimated Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2009)
If success rate over 90%, VATS major pulmonary resection with SND is considered as feasible procedures for clinical stage IIIA non-small cell lung cancer (Success is defined as VATS major pulmonary resection with SND without conversion). [ Time Frame: 2 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2009)
To evaluate the intraoperative(surgical duration, estimated blood loss) and postoperative variables(mortality, morbidity, chest tube drainage duration, wound pain, hospital stay) [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Video-assisted Thoracoscopic Surgery for Stage IIIA Non-Small Cell Lung Cancer
Official Title  ICMJE Feasibility of Video-Assisted Thoracoscopic Surgery for Clinical Stage IIIA Non-Small Cell Lung Cancer
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 cell lung cancer. Success is defined as VATS major pulmonary resection with SND without conversion. If success rate over 90%, VATS major pulmonary resection with SND is considered as feasible procedures for clinical stage IIIA non-small cell lung cancer.
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-assisted thoracoscopic surgery (VATS) is the accepted technique for biopsy of the lung and pleura and surgical treatment of pneumothorax. A VATS lobectomy with systematic node dissection (SND) for non-small cell lung cancer (NSCLC) has been gradually introduced by many thoracic surgeons since it was first performed in 1995 by McKenna and associates. They reported that the survival rate for stage I lung cancer is similar between lobectomies done by VATS and by thoracotomy. Although minimally invasive surgery certainly sounds good, it is problematic if it decreases patient's safety or the oncological treatment's effect. Hence, the feasibility and safety of SND by VATS remain controversial. In many institutions, the indication for VATS major pulmonary resection is limited to clinical stage I or II. For the application of the procedure to clinical stage IIIA, it remains controversial. Recently, Watanabe et al. did a retrospective study aimed at determining the outcome of patients with cN0-pN2 NSCLC who underwent VATS major pulmonary resection with SND versus the outcome after major pulmonary resection with SND by open thoracotomy. It demonstrated that VATS major pulmonary resection with SND was a feasible approach to management of cN0-pN2 NSCLC without loss of curability. It was unnecessary to convert the VATS approach to thoracotomy in order to do SND even if pN2 disease is revealed during VATS major pulmonary resection. The purpose of this study is to know whether VATS major pulmonary resection with SND for clinical stage IIIA non-small cell lung cancer is possible.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE Procedure: VATS
video-assisted thoracoscopic surgery (VATS) major pulmonary resection with systematic node dissection (SND) for clinical stage IIIA non-small cell lung cancer
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 13, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2009
Estimated Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00862004
Other Study ID Numbers  ICMJE FAHG20081202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guangzhou Medical College, the First Affiliated Hospital of Guangzhou Medical College
Study Sponsor  ICMJE The First Affiliated Hospital of Guangzhou Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jianxing He, MD, FACS Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
PRS Account The First Affiliated Hospital of Guangzhou Medical University
Verification Date March 2009

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