NCT01707888

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
1.9 years until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

January 27, 2015

Status Verified

January 1, 2015

Enrollment Period

2.8 years

First QC Date

October 13, 2012

Last Update Submit

January 24, 2015

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • morbidity and mortility rate

    perioperative complications and death rates of the group

    3 moths

Secondary Outcomes (7)

  • Disease-free survival

    3y

  • Rate of loco-regional and systemic recurrence

    3y

  • Pulmonary function

    6 months after surgery

  • Postoperative hospital stay.

    3 months postoperatively

  • Postoperative drainage duration

    3 months postoperatively

  • +2 more secondary outcomes

Study Arms (1)

major lung resection

Patients undergo major lung resection by thoracoscopy/VATS.

Procedure: Thoracoscopy/VATS

Interventions

Thoracoscopy/VATSPROCEDURE

Patients undergo major lung resection by thoracoscopic surgery or video assisted thoracoscopic surgery.

Also known as: Minimal invasive surgery
major lung resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

clinical early stage(I/II) lung cancer

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100044, China

NOT YET RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100044, China

NOT YET RECRUITING

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, 100044, China

NOT YET RECRUITING

Beijing Haidian Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Beijing Friendship Hospital

Beijing, China

NOT YET RECRUITING

Peking university people's hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jun Wang, MD

    Peking University People's Hospital

    STUDY CHAIR

  • Fan Yang, MD

    Peking University People's Hospital

    STUDY DIRECTOR

  • Zhao Xi Sui, MD

    Peking University People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Jun Wang, MD

CONTACT

88324078Jwangmd@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

October 13, 2012

First Posted

October 16, 2012

Study Start

September 1, 2014

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

January 27, 2015

Record last verified: 2015-01

Locations

CN(6)