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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00862004
• Other study ID #: FAHG20081202
• Status: Recruiting
• Phase: Phase 2
• First received: March 13, 2009
• Last updated: February 1, 2010
• Start date: December 2008
• Est. completion date: December 2009

Study information

• Verified date: March 2009
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Jianxing He, MD, FACS
• Phone: +86-20-83337792
• Email: drjianxing.he[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Procedure:
• VATS
video-assisted thoracoscopic surgery (VATS) major pulmonary resection with systematic node dissection (SND) for clinical stage IIIA non-small cell lung cancer

Locations

Country	Name	City	State
China	Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

He J, Yang Y, Chen M. [Lobectomy by video-assisted thoracoscopic surgery]. Zhonghua Wai Ke Za Zhi. 1996 Feb;34(2):76-8. Chinese. — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		2 month	No
Secondary	To evaluate the intraoperative(surgical duration, estimated blood loss) and postoperative variables(mortality, morbidity, chest tube drainage duration, wound pain, hospital stay)		6 months	No

External Links

•   VATS for Thoracic Disease