NCT03451526

Brief Summary

The trial was designed to compare the effectiveness of radical resections of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies in the patients with 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
2,929

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

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

December 1, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

Same day

First QC Date

February 2, 2018

Last Update Submit

May 18, 2018

Conditions

Keywords

Chinesereal-world evidencesNSCLCsurgeries

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Overall survival

    2014 - 2017

Secondary Outcomes (1)

  • Disease-free survival

    2014 - 2017

Other Outcomes (16)

  • Overall survivals in the subgroups

    2014 - 2017

  • Disease-free survivals in the subgroups

    2014 - 2017

  • Impact factors of overall survival as measured by age

    2014 - 2017

  • +13 more other outcomes

Study Arms (2)

Surgeries+adjuvant chemotherapies

Patients who received radical resection of lung cancer + adjuvant chemotherapies

Procedure: Surgeries

Perioperative chemotherapies

Patients who received perioperative chemotherapies

Procedure: Surgeries

Interventions

SurgeriesPROCEDURE

Surgeries plus adjuvant chemotherapies or perioperative chemotherapies

Also known as: Adjuvant chemotherapies or perioperative chemotherapies
Perioperative chemotherapiesSurgeries+adjuvant chemotherapies

Eligibility Criteria

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

Pathologically diagnosed Chinese patients with N2 non-small cell lung cancer who received radical resection of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies

You may qualify if:

  • Patients with radical resection of lung cancer enrolled from 2014 to 2019;
  • Pathologically diagnosed patients with non-small cell lung cancer;
  • Patients with age \> 18 years old;
  • Patients who did not receive chest surgeries before hospitalization;
  • Patients with N2 lymph nodes (+) after surgeries;
  • Patients who received lymphadenectomy for one group or more groups of lymph nodes;

You may not qualify if:

  • Patients with second primary tumors or multiple primary tumors;

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, 450008, 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, 200003, 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

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

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

February 2, 2018

First Posted

March 1, 2018

Study Start

December 1, 2017

Primary Completion

December 1, 2017

Study Completion

March 30, 2018

Last Updated

May 21, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations