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

Non-small Cell Lung Cancer Clinical Trial

Official title:

VATS Major Lung Resection for Chinese Early-stage Non-small Cell Lung cancer-a Registry Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01707888
• Other study ID #: PEKUPH1201
• Status: Recruiting
• Phase: Phase 3
• First received: October 13, 2012
• Last updated: January 24, 2015
• Start date: September 2014
• Est. completion date: June 2017

Study information

• Verified date: January 2015
• Source: Peking University People's Hospital
• Contact: Jun Wang, MD
• Phone: 88324078
• Email: Jwangmd[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Thoracoscopy/VATS
Patients undergo major lung resection by thoracoscopic surgery or video assisted thoracoscopic surgery.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing
China	Beijing Cancer Hospital	Beijing	Beijing
China	Beijing Chao-Yang Hospital	Beijing	Beijing
China	Beijing Friendship Hospital	Beijing
China	Beijing Haidian Hospital	Beijing	Beijing
China	Peking university people's hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morbidity and mortility rate	perioperative complications and death rates of the group	3 moths	Yes
Secondary	Disease-free survival	To evaluate Disease Free Survival (DFS) of the group.	3y	No
Secondary	Rate of loco-regional and systemic recurrence	To evaluate the rate of loco-regional and systemic recurrence of the group.	3y	No
Secondary	Pulmonary function	to evaluate the pulmonary function as measured by expiratory flow rate of the group 6 months postoperatively.	6 months after surgery	No
Secondary	Postoperative hospital stay.	to evaluate the postoperative hospital stay of the group.	3 months postoperatively	Yes
Secondary	Postoperative drainage duration	to evaluate the postoperative drainage duration of the group.	3 months postoperatively	Yes
Secondary	overall survival	to evaluate the overall survival rate of the group.	3 months postoperatively	No
Secondary	converted rate	the rate of converted thoracotomy	3 months	No