A Study to Explore Prognoses of the Patients With N2 Non-small Cell Lung Cancer

A Multi-centre Real-world Non-interventional Observational Study to Compare Prognoses of the Chinese Patients With N2 Non-small Cell Lung Cancer Who Received Adjuvant Chemotherapies and Perioperative Chemotherapies After Surgeries

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

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Procedure: Surgeries

Detailed Description

The trial is a multi-centre real-world non-interventional observational study. The Chinese patients with N2 non-small cell lung cancer enrolled from 2014 to 2017 who received radical resections of lung cancer and adjuvant chemotherapies will be included in the study and the study data on patient demographic/tumor biological characteristics and clinical treatment will be collected to evaluate compare effectiveness of radical resection of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies after surgeries.

• Study Type: Observational
• Enrollment (Actual): 2929

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital
    • Beijing, Beijing, China, 100853
      • China PLA General Hospital
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Affiliated to Huazhong Technology Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Cancer Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • Xi'an Tangdu Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200003
      • Shanghai Chest Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Huaxi Hospital Affiliated to Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300051
      • Tianjin Chest Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • First Hospital Affiliated to Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

• Patients with second primary tumors or multiple primary tumors;

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgeries+adjuvant chemotherapies; Patients who received radical resection of lung cancer + adjuvant chemotherapies	Procedure: Surgeries; Surgeries plus adjuvant chemotherapies or perioperative chemotherapies; Other Names: Adjuvant chemotherapies or perioperative chemotherapies
Perioperative chemotherapies; Patients who received perioperative chemotherapies	Procedure: Surgeries; Surgeries plus adjuvant chemotherapies or perioperative chemotherapies; Other Names: Adjuvant chemotherapies or perioperative chemotherapies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival	2014 - 2017

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	Disease-free survival	2014 - 2017

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survivals in the subgroups	Overall survivals in the subgroups categorized by T staging	2014 - 2017
Disease-free survivals in the subgroups	Disease-free survivals in the subgroups categorized by T staging	2014 - 2017
Impact factors of overall survival as measured by age	Impact factors of overall survival as measured by age	2014 - 2017
Impact factors of overall survival as measured by gender	Impact factors of overall survival as measured by gender	2014 - 2017
Impact factors of overall survival as measured by BMI	Impact factors of overall survival as measured by BMI	2014 - 2017
Impact factors of overall survival as measured by tumor size	Impact factors of overall survival as measured by tumor size	2014 - 2017
Impact factors of overall survival as measured by tumor location	Impact factors of overall survival as measured by tumor location	2014 - 2017
Impact factors of overall survival as measured by T staging	Impact factors of overall survival as measured by T staging	2014 - 2017
Impact factors of overall survival as measured by clinical treatments	Impact factors of overall survival as measured by surgeries plus adjuvant chemotherapies and surgeries plus perioperative chemotherapies	2014 - 2017
Time to local recurrence	Time to local recurrence	2014 - 2017
Time to distant recurrence	Time to distant recurrence	2014 - 2017
Death rate within 30/90 days after surgeries	Death rate within 30/90 days after surgeries	2014 - 2017
Impact factors of death rate within 30/90 days after surgeries as measured by patient demographic characteristics	Impact factors of death rate within 30/90 days after surgeries as measured by patient demographic characteristics	2014 - 2017
Impact factors of death rate within 30/90 days after surgeries as measured by tumor biological characteristics	Impact factors of death rate within 30/90 days after surgeries as measured by tumor biological characteristics	2014 - 2017
Impact factors of death rate within 30/90 days after surgeries as measured by various modes of surgeries	Impact factors of death rate within 30/90 days after surgeries as measured by various modes of surgeries	2014 - 2017
Incidence of perioperative complications	Incidence of perioperative complications	2014 - 2017

Collaborators and Investigators

• Sponsor: Tang-Du Hospital
• Collaborators: LinkDoc Technology (Beijing) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: February 23, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 18, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: NSCLC; Chinese; real-world evidences; surgeries
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: W-TONG04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No