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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03451526
• Other study ID #: W-TONG04
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: March 30, 2018

Study information

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

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2929
• Est. completion date: March 30, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Surgeries
Surgeries plus adjuvant chemotherapies or perioperative chemotherapies

Locations

Country	Name	City	State
China	China PLA General Hospital	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Huaxi Hospital Affiliated 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 Huazhong Technology Hospital	Wuhan	Hubei
China	Xi'an Tangdu Hospital	Xi'an	Shaanxi
China	Henan cancer hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Tang-Du 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 categorized by T staging	2014 - 2017
Other	Disease-free survivals in the subgroups	Disease-free survivals in the subgroups categorized by T staging	2014 - 2017
Other	Impact factors of overall survival as measured by age	Impact factors of overall survival as measured by age	2014 - 2017
Other	Impact factors of overall survival as measured by gender	Impact factors of overall survival as measured by gender	2014 - 2017
Other	Impact factors of overall survival as measured by BMI	Impact factors of overall survival as measured by BMI	2014 - 2017
Other	Impact factors of overall survival as measured by tumor size	Impact factors of overall survival as measured by tumor size	2014 - 2017
Other	Impact factors of overall survival as measured by tumor location	Impact factors of overall survival as measured by tumor location	2014 - 2017
Other	Impact factors of overall survival as measured by T staging	Impact factors of overall survival as measured by T staging	2014 - 2017
Other	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
Other	Time to local recurrence	Time to local recurrence	2014 - 2017
Other	Time to distant recurrence	Time to distant recurrence	2014 - 2017
Other	Death rate within 30/90 days after surgeries	Death rate within 30/90 days after surgeries	2014 - 2017
Other	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
Other	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
Other	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
Other	Incidence of perioperative complications	Incidence of perioperative complications	2014 - 2017
Primary	Overall survival	Overall survival	2014 - 2017
Secondary	Disease-free survival	Disease-free survival	2014 - 2017