Clinical trial NCT03451526: A Study to Explore Prognoses of the Patients With N2 Non-small Cell Lung Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Keywords: Chinese
real-world evidences
NSCLC
surgeries
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
Collaborators: name: LinkDoc Technology (Beijing) Co. Ltd.
First posted: 2018-03-01
Enrollment: 2929
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

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

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Overall survival
timeFrame: 2014 - 2017
Secondary outcomes:
measure: Disease-free survival
timeFrame: 2014 - 2017
Other outcomes:
measure: Overall survivals in the subgroups
timeFrame: 2014 - 2017
measure: Disease-free survivals in the subgroups
timeFrame: 2014 - 2017
measure: Impact factors of overall survival as measured by age
timeFrame: 2014 - 2017
measure: Impact factors of overall survival as measured by gender
timeFrame: 2014 - 2017
measure: Impact factors of overall survival as measured by BMI
timeFrame: 2014 - 2017
measure: Impact factors of overall survival as measured by tumor size
timeFrame: 2014 - 2017
measure: Impact factors of overall survival as measured by tumor location
timeFrame: 2014 - 2017
measure: Impact factors of overall survival as measured by T staging
timeFrame: 2014 - 2017
measure: Impact factors of overall survival as measured by clinical treatments
timeFrame: 2014 - 2017
measure: Time to local recurrence
timeFrame: 2014 - 2017
measure: Time to distant recurrence
timeFrame: 2014 - 2017
measure: Death rate within 30/90 days after surgeries
timeFrame: 2014 - 2017
measure: Impact factors of death rate within 30/90 days after surgeries as measured by patient demographic characteristics
timeFrame: 2014 - 2017
measure: Impact factors of death rate within 30/90 days after surgeries as measured by tumor biological characteristics
timeFrame: 2014 - 2017
measure: Impact factors of death rate within 30/90 days after surgeries as measured by various modes of surgeries
timeFrame: 2014 - 2017
measure: Incidence of perioperative complications
timeFrame: 2014 - 2017
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: China PLA General Hospital
state: Beijing
city: Zhengzhou
country: China
facility: Henan cancer hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Huazhong Technology Hospital
state: Hubei
city: Nanjing
country: China
facility: Jiangsu cancer hospital
state: Jiangsu
city: Xi'an
country: China
facility: Xi'an Tangdu Hospital
state: Shaanxi
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Chengdu
country: China
facility: Huaxi Hospital Affiliated to Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Hangzhou
country: China
facility: First Hospital Affiliated to Zhejiang University
state: Zhejiang
Study officials:
References: