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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429673
• Other study ID #: CJ-LC-01
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: May 2018
• Source: China-Japan Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The trial was designed to compare effectiveness and safety of surgeries in the patients with non-small cell lung cancer

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10885
• Est. completion date: March 30, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Procedure:
• Surgeries
Lobectomy or segment/wedge dissection

Locations

Country	Name	City	State
China	China People's Liberation Army Hospital	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Huaxi Hospital Affiliate to Sichuan University	Chengdu	Sichuan
China	First Hospital Affiliated to Zhejiang University	Hangzhou	Zhejiang
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Tianjin Chest Hospital	Tianjin	Tianjin
China	Tongji Hospital Affiliated to Huaxi Technology University	Wuhan	Hubei
China	Xi'an Tangdu Hospital	Xi'an	Shaanxi
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital	LinkDoc Technology (Beijing) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

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