Video-assisted Thoracoscopic Surgery for Stage IIIA Non-Small Cell Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
VATS
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring video-assisted thoracoscopic surgery (VATS), systematic node dissection (SND), stage IIIA non-small cell lung cancer
Eligibility Criteria
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
Sites / Locations
- Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical CollegeRecruiting
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
To evaluate the intraoperative(surgical duration, estimated blood loss) and postoperative variables(mortality, morbidity, chest tube drainage duration, wound pain, hospital stay)
Full Information
NCT ID
NCT00862004
First Posted
March 13, 2009
Last Updated
February 1, 2010
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT00862004
Brief Title
Video-assisted Thoracoscopic Surgery for Stage IIIA Non-Small Cell Lung Cancer
Official Title
Feasibility of Video-Assisted Thoracoscopic Surgery for Clinical Stage IIIA Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2008 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
The First Affiliated Hospital of Guangzhou Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
video-assisted thoracoscopic surgery (VATS), systematic node dissection (SND), stage IIIA non-small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
VATS
Intervention Description
video-assisted thoracoscopic surgery (VATS) major pulmonary resection with systematic node dissection (SND) for clinical stage IIIA non-small cell lung cancer
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianxing He, MD, FACS
Phone
+86-20-83337792
Email
drjianxing.he@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianxing He, MD, FACS
Organizational Affiliation
Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daoyuan Wang, MD
Phone
+86-20-83337792
Email
wangdy@vip.163.com
First Name & Middle Initial & Last Name & Degree
Wenlong Shao, MD
Phone
+86-20-83337792
Email
myfriends2003@126.com
First Name & Middle Initial & Last Name & Degree
Jianxing He, MD, FACS
12. IPD Sharing Statement
Citations:
PubMed Identifier
18342533
Citation
Watanabe A, Mishina T, Ohori S, Koyanagi T, Nakashima S, Mawatari T, Kurimoto Y, Higami T. Is video-assisted thoracoscopic surgery a feasible approach for clinical N0 and postoperatively pathological N2 non-small cell lung cancer? Eur J Cardiothorac Surg. 2008 May;33(5):812-8. doi: 10.1016/j.ejcts.2008.01.064. Epub 2008 Mar 14.
Results Reference
result
PubMed Identifier
9388326
Citation
He J, Yang Y, Chen M. [Lobectomy by video-assisted thoracoscopic surgery]. Zhonghua Wai Ke Za Zhi. 1996 Feb;34(2):76-8. Chinese.
Results Reference
result
PubMed Identifier
18282386
Citation
Shao WL, Liu LX, He JX, Yang YY, Chen HZ, Wu ZF, Wei B, Yin WQ, Yang DK. [Bronchial sleeve resection and reconstruction of pulmonary artery by video-assisted thoracic small incision surgery for central lung cancer: a report of 139 cases]. Zhonghua Wai Ke Za Zhi. 2007 Nov 15;45(22):1530-2. Chinese.
Results Reference
result
Learn more about this trial
Video-assisted Thoracoscopic Surgery for Stage IIIA Non-Small Cell Lung Cancer
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