Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Peking University People's Hospital
Sponsor:
Information provided by (Responsible Party):
Jun Wang, Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT01707888
First received: October 13, 2012
Last updated: January 24, 2015
Last verified: January 2015

October 13, 2012
January 24, 2015
September 2014
June 2017   (final data collection date for primary outcome measure)
morbidity and mortility rate [ Time Frame: 3 moths ] [ Designated as safety issue: Yes ]
perioperative complications and death rates of the group
overall survival [ Time Frame: 5y ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    To evaluate Disease Free Survival (DFS) of the group.
  • Rate of loco-regional and systemic recurrence [ Time Frame: 3y ] [ Designated as safety issue: No ]
    To evaluate the rate of loco-regional and systemic recurrence of the group.
  • Pulmonary function [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    to evaluate the postoperative hospital stay of the group.
  • Postoperative drainage duration [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: Yes ]
    to evaluate the postoperative drainage duration of the group.
  • overall survival [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
    to evaluate the overall survival rate of the group.
  • converted rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    the rate of converted thoracotomy
  • Disease-free survival [ Time Frame: 5y ] [ Designated as safety issue: No ]
    To evaluate Disease Free Survival (DFS) of two groups.
  • Rate of loco-regional and systemic recurrence [ Time Frame: 5y ] [ Designated as safety issue: No ]
    To evaluate the rate of loco-regional and systemic recurrence of the two groups.
  • Pulmonary function [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    to evaluate the postoperative hospital stay of the two groups
  • Postoperative drainage duration [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: Yes ]
    to evaluate the postoperative drainage duration of the two groups.
  • postoperative morbidity and mortality [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: Yes ]
    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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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.
Both
18 Years and older
No
Contact: Jun Wang, MD 88324078 Jwangmd@yahoo.com
China
 
NCT01707888
PEKUPH1201
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP