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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Jun Wang, Peking University People's Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01707888
First Posted: October 16, 2012
Last Update Posted: January 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jun Wang, Peking University People's Hospital
October 13, 2012
October 16, 2012
January 27, 2015
September 2014
June 2017   (Final data collection date for primary outcome measure)
morbidity and mortility rate [ Time Frame: 3 moths ]
perioperative complications and death rates of the group
overall survival [ Time Frame: 5y ]
To evaluate the 5 year overall survival (OS) rate of two groups.
Complete list of historical versions of study NCT01707888 on ClinicalTrials.gov Archive Site
  • Disease-free survival [ Time Frame: 3y ]
    To evaluate Disease Free Survival (DFS) of the group.
  • Rate of loco-regional and systemic recurrence [ Time Frame: 3y ]
    To evaluate the rate of loco-regional and systemic recurrence of the group.
  • Pulmonary function [ Time Frame: 6 months after surgery ]
    to evaluate the pulmonary function as measured by expiratory flow rate of the group 6 months postoperatively.
  • Postoperative hospital stay. [ Time Frame: 3 months postoperatively ]
    to evaluate the postoperative hospital stay of the group.
  • Postoperative drainage duration [ Time Frame: 3 months postoperatively ]
    to evaluate the postoperative drainage duration of the group.
  • overall survival [ Time Frame: 3 months postoperatively ]
    to evaluate the overall survival rate of the group.
  • converted rate [ Time Frame: 3 months ]
    the rate of converted thoracotomy
  • Disease-free survival [ Time Frame: 5y ]
    To evaluate Disease Free Survival (DFS) of two groups.
  • Rate of loco-regional and systemic recurrence [ Time Frame: 5y ]
    To evaluate the rate of loco-regional and systemic recurrence of the two groups.
  • Pulmonary function [ Time Frame: 6 months after surgery ]
    to evaluate the pulmonary function as measured by expiratory flow rate of the two groups 6 months postoperatively.
  • Postoperative hospital stay. [ Time Frame: 3 months postoperatively ]
    to evaluate the postoperative hospital stay of the two groups
  • Postoperative drainage duration [ Time Frame: 3 months postoperatively ]
    to evaluate the postoperative drainage duration of the two groups.
  • postoperative morbidity and mortality [ Time Frame: 3 months postoperatively ]
    to evaluate the postoperative morbidity and mortality of the two groups.
Not Provided
Not Provided
 
VATS Major Lung Resection for Chinese Early-stage Non-small Cell Lung Cancer
VATS Major Lung Resection for Chinese Early-stage Non-small Cell Lung cancer-a Registry Study
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.
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.
Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
3 Years
Not Provided
Probability Sample
clinical early stage(I/II) lung cancer
Non-small Cell Lung Cancer
Procedure: Thoracoscopy/VATS
Patients undergo major lung resection by thoracoscopic surgery or video assisted thoracoscopic surgery.
Other Name: Minimal invasive surgery
major lung resection
Patients undergo major lung resection by thoracoscopy/VATS.
Intervention: Procedure: Thoracoscopy/VATS
Not Provided
 
Unknown status
500
June 2017
June 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01707888
PEKUPH1201
No
Not Provided
Not Provided
Jun Wang, Peking University People's Hospital
Peking University People's Hospital
Not Provided
Study Chair: Jun Wang, MD Peking University People's Hospital
Study Director: Fan Yang, MD Peking University People's Hospital
Study Director: Zhao Xi Sui, MD Peking University People's Hospital
Peking University People's Hospital
January 2015