VATS Major Lung Resection for Chinese Early-stage Non-small Cell Lung Cancer

• Conditions: Non-small Cell Lung Cancer
• Interventions: Procedure: Thoracoscopy/VATS

• Registration Number: NCT01707888
• Lead Sponsor: Peking University People's Hospital

Brief Summary

Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS major lung resection have been preferred as a standard radical procedure for early stage non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major lung resection for lung cancer as a real-world study in china.

Detailed Description

Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS major lung resection have been preferred as a standard radical procedure for early stage non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major lung resection for lung cancer as a real-world study in china.This is a multicenter, prospective study, aimed To evaluate the short-term and long- term outcome of VATS major lung resection for early stage lung cancer. Patients will be followed up every 3 months for 3 years.

Study Timeline

• Study First Submitted: 2012-10-13
• Study First Submitted QC: 2012-10-15
• Study First Posted: 2012-10-16
• Study Start: 2014-09
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-24
• Last Update Posted: 2015-01-27
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Preoperative criteria:

i) non-small cell lung cancer is suspected, ii) clinical stage I/II (3) Intraoperative criteria: i) Histologically confirmed NSCLC, ii) resected by VATS or converted open lobectomy,sleeve lobectomy or pneumonectomy and nodal dissection/sampling.

(4) No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).

(5) No prior chemotherapy or radiation therapy for any malignant diseases. (6) Expected postoperative FEV1.0>=800 mL and PaO2>=65 torr. (7) Performance status of 0 or 1. (8) Sufficient organ functions. (9) Written informed consent.

Exclusion Criteria

1. Active bacterial or fungous infection.
2. Simultaneous or metachronous (within the past 5 years) double cancers.
3. Women during pregnancy or breast-feeding.
4. Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
5. Psychosis.
6. Systemic steroids medication.
7. Uncontrollable diabetes mellitus.
8. Uncontrollable hypertension.
9. History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
major lung resection	Thoracoscopy/VATS	Patients undergo major lung resection by thoracoscopy/VATS.

Primary Outcome Measures

Name	Time	Method
morbidity and mortility rate	3 moths	perioperative complications and death rates of the group

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	3y	To evaluate Disease Free Survival (DFS) of the group.
Rate of loco-regional and systemic recurrence	3y	To evaluate the rate of loco-regional and systemic recurrence of the group.
Pulmonary function	6 months after surgery	to evaluate the pulmonary function as measured by expiratory flow rate of the group 6 months postoperatively.
Postoperative hospital stay.	3 months postoperatively	to evaluate the postoperative hospital stay of the group.
Postoperative drainage duration	3 months postoperatively	to evaluate the postoperative drainage duration of the group.
overall survival	3 months postoperatively	to evaluate the overall survival rate of the group.
converted rate	3 months	the rate of converted thoracotomy

Trial Locations

Locations (6)

Beijing Friendship Hospital; 🇨🇳 Beijing, China

Beijing Haidian Hospital; 🇨🇳 Beijing, Beijing, China

Peking university people's hospital; 🇨🇳 Beijing, China

Beijing Chao-Yang Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China