A Study to Evaluate Effectiveness and Safety of Surgeries in Elderly NSCLC Patients

A Multi-centre Real-world Non-interventional Observational Study to Evaluate Effectiveness and Safety of Surgeries in the Chinese Early-stage Patients With Non-small Cell Lung Cancer

The trial was designed to compare effectiveness and safety of surgeries in the patients with 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 elderly pathologically diagnosed patients with early-stage non-small cell lung cancer enrolled from 2015 to 2017 who received lobectomy or segment/wedge dissection were included and the study data on patient demographic/tumor biological characteristics, and clinical treatments were retrospectively collected to evaluate effectiveness and safety of the surgeries.

• Study Type: Observational
• Enrollment (Actual): 10885

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital
    • Beijing, Beijing, China, 100853
      • China People's Liberation Army Hospital
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Affiliated to Huaxi Technology University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Cancer Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • Xi'an Tangdu Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Chest Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Huaxi Hospital Affiliate 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: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pathological diagnosed elderly Chinese patients with non-small cell lung cancer who received lobectomy or segment/wedge dissection

Description

Inclusion Criteria:

• Patients who received surgeries from 2014 to 2017;
• Patients who received lobectomy or segment/wedge dissection;
• Pathologically diagnosed patients with non-small cell lung cancer;
• Patients with age >=65 years old.

Exclusion Criteria:

• Patients who received neoadjuvant therapy prior to surgery.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with surgeries; Pathologically diagnosed elderly early Chinese patients with non-small cell lung cancer who received lobectomy or segment/wedge dissection	Procedure: Surgeries; Lobectomy or segment/wedge dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival	2015-2017

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survivals in the subgroups	Overall survivals in the subgroups categorised by age, tumor size, and clinical/pathological staging	2015-2017
Impact factors of overall survival	Impact factors of overall survival as measured by patient demographic/tumor biological characteristics	2015-2017
Death rate within 30/90 days after surgeries	Death rate within 30/90 days after surgeries	2015-2017
Incidence of perioperative complications	Incidence of perioperative complications	2015-2017

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Collaborators: LinkDoc Technology (Beijing) Co. Ltd.

Publications and helpful links

General Publications

• Zhang Z, Feng H, Zhao H, Hu J, Liu L, Liu Y, Li X, Xu L, Li Y, Lu X, Fu X, Yang H, Liu D. Sublobar resection is associated with better perioperative outcomes in elderly patients with clinical stage I non-small cell lung cancer: a multicenter retrospective cohort study. J Thorac Dis. 2019 May;11(5):1838-1848. doi: 10.21037/jtd.2019.05.20.

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: January 30, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (ACTUAL): February 12, 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: CJ-LC-01

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