Clinical trial NCT01707888: VATS Major Lung Resection for Chinese Early-stage Non-small Cell Lung Cancer
Official title: VATS Major Lung Resection for Chinese Early-stage Non-small Cell Lung cancer-a Registry Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: clinical early stage(I/II) lung cancer

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.

Eligibility criteria: 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.

Primary outcomes:
measure: morbidity and mortility rate
timeFrame: 3 moths
Secondary outcomes:
measure: Disease-free survival
timeFrame: 3y
measure: Rate of loco-regional and systemic recurrence
timeFrame: 3y
measure: Pulmonary function
timeFrame: 6 months after surgery
measure: Postoperative hospital stay.
timeFrame: 3 months postoperatively
measure: Postoperative drainage duration
timeFrame: 3 months postoperatively
measure: overall survival
timeFrame: 3 months postoperatively
measure: converted rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Haidian Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital
city: Beijing
country: China
facility: Peking university people's hospital
Study officials:
affiliation: Peking University People's Hospital
name: Jun Wang, MD
role: STUDY_CHAIR
affiliation: Peking University People's Hospital
name: Fan Yang, MD
role: STUDY_DIRECTOR
affiliation: Peking University People's Hospital
name: Zhao Xi Sui, MD
role: STUDY_DIRECTOR
References: