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Feasibility of Video-Assisted Thoracoscopic Surgery for Clinical Stage IIIA Non-Small Cell Lung Cancer

Phase 2
18 Years
80 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

Feasibility of Video-Assisted Thoracoscopic Surgery for Clinical Stage IIIA Non-Small Cell Lung Cancer

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

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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).

Outcome Time Frame:

2 month

Safety Issue:


Principal Investigator

Jianxing He, MD, FACS

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College


China: Food and Drug Administration

Study ID:




Start Date:

December 2008

Completion Date:

December 2009

Related Keywords:

  • Non-Small Cell Lung Cancer
  • video-assisted thoracoscopic surgery (VATS)
  • systematic node dissection (SND)
  • stage IIIA non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms