NCT03613467

Brief Summary

The study was designed to compare the safety and effectiveness of vedio-assisted thoracoscopic lobectomy with open lobectomy for patients with surgically resectable pathologic N2 non-small cell lung cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,145

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

10 active sites

Status
completed

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

Study Start

First participant enrolled

July 4, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2018

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

Same day

First QC Date

July 16, 2018

Last Update Submit

August 7, 2018

Conditions

Non-small Cell Lung Cancer

Keywords

Vedio-assisted thoracoscopic lobectomyThoracotomy lobectomyReal-world evidences;pN2 NSCLC

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Overall survival

    2014-2018

Secondary Outcomes (5)

  • Duration of hospital stay [Perioperative outcomes]

    2014-2017

  • Postoperative 30 and 90 days [Perioperative outcomes]

    2014-2017

  • Drainage time [Perioperative outcomes]

    2014-2017

  • Intraoperative blood loss [Perioperative outcomes]

    2014-2017

  • Postoperative complications [Perioperative outcomes]

    2014-2017

Other Outcomes (9)

  • Overall survivals in the subgroups stratified by T staging

    2014-2018

  • Overall survivals in the subgroups stratified by neoadjuvant therapy

    2014-2018

  • Overall survivals in the subgroups stratified by number of lymph node station involved

    2014-2018

  • +6 more other outcomes

Study Arms (2)

VATS lobectomy

Pathologic N2 NSCLC patients who received lobectomy by video-assisted thoracoscopic surgery

Procedure: VATS lobectomy

Thoracotomy lobectomy

Pathologic N2 NSCLC patients who received lobectomy by thoracotomy

Procedure: Thoracotomy lobectomy

Interventions

VATS lobectomyPROCEDURE

Patients who received lobectomy by video-assisted thoracoscopic surgery

VATS lobectomy
Thoracotomy lobectomyPROCEDURE

Patients who received lobectomy by thoracotomy

Thoracotomy lobectomy

Eligibility Criteria

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

Pathologically diagnosed N2 non-small cell lung cancer who received VATS or thoracotomy lobectomy between 2014 and 2017

You may qualify if:

  • Patients with age \> 18 years old;
  • Patients with pathologically diagnosed non-small cell lung cancer;
  • Patients underwent lobectomy by either VATS or thoracotomy between 2014 and 2017;
  • Patients who received lymphadenectomy for all accessible lymph nodes;
  • Patients with N2 lymph nodes (+) after surgeries;

You may not qualify if:

  • Patients with second primary tumors or multiple primary tumors;
  • Patients who received chest surgeries before hospitalization;
  • Patients with superior pulmonary sulcus tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

China PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

Tongji Hospital Affiliated to Huazhong Technology Hospital

Wuhan, Hubei, 430030, China

Location

Jiangsu cancer hospital

Nanjing, Jiangsu, 210009, China

Location

Xi'an Tangdu Hospital

Xi'an, Shaanxi, 710000, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Huaxi Hospital Affiliated to Sichuan University

Chengdu, Sichuan, 610041, China

Location

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, 300051, China

Location

First Hospital Affiliated to Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

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

  • Xiaofei Li, PhD

    Tang-Du Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 16, 2018

First Posted

August 3, 2018

Study Start

July 4, 2018

Primary Completion

July 4, 2018

Study Completion

July 6, 2018

Last Updated

August 9, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(10)