Clinical trial NCT03429673: A Study to Evaluate Effectiveness and Safety of Surgeries in Elderly NSCLC Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Keywords: Chinese
real-world evidences
NSCLC
surgeries
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
Collaborators: name: LinkDoc Technology (Beijing) Co. Ltd.
First posted: 2018-02-12
Enrollment: 10885
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: 2015-2017
Secondary outcomes:
Other outcomes:
measure: Overall survivals in the subgroups
timeFrame: 2015-2017
measure: Impact factors of overall survival
timeFrame: 2015-2017
measure: Death rate within 30/90 days after surgeries
timeFrame: 2015-2017
measure: Incidence of perioperative complications
timeFrame: 2015-2017
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: China People's Liberation Army Hospital
state: Beijing
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Huaxi Technology University
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 Affiliate 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:
citation: 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.