NCT03429192

Brief Summary

A study to compare patient survivals in the N2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,653

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

February 5, 2018

Last Update Submit

May 18, 2018

Conditions

Keywords

Chinese, real-world evidences, NSCLC, lymph skip metastases

Outcome Measures

Primary Outcomes (1)

  • Difference in overall survival (OS)

    OS difference in the subgroups of N2 patients with lymph skip metastases and non-skip metastases

    2014 - 2017

Secondary Outcomes (1)

  • Percentage of N2 patients with lymph skip metastases

    2014 - 2017

Other Outcomes (2)

  • Difference in overall survival (OS) (in the subgroups of patients)

    2014 - 2017

  • Hazard factors of overall survival

    2014 - 2017

Study Arms (1)

N2 non-small cell lung cancer

Chinese patients with N2 non-small cell lung cancer

Procedure: Surgery

Interventions

SurgeryPROCEDURE

Surgeries plus dissection of lymph nodes

N2 non-small cell lung cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pathologically diagnosed Chinese NSCLC patients with chest surgeries and lymphadenectomy

You may qualify if:

  • Patients with surgeries from 2014 to 2017;
  • Pathologically diagnosed patients with non-small cell lung cancer;
  • Age \> 18 years old;
  • Patients with chest surgeries before hospitalization;
  • Patients with N2 lymph nodes (+) after surgeries who received lymphadenectomy (Group 10 and 11 lymph nodes);

You may not qualify if:

  • \- Patients with radiotherapies, chemotherapies and biological therapies for tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

China People's Liberation Army Hospital

Beijing, Beijing Municipality, 100853, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

Tongji Hospital Affiliated to Huaxi Technology University

Wuhan, Hubei, 430030, China

Location

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Xi'an Tangdu Hospital

Xi'an, Shanghai Municipality, 710000, China

Location

Huaxi Hospital Affiliate to Sichuan University

Chengdu, Sichuan, 610041, China

Location

First Hospital Affiliated to Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (1)

  • Li X, Li X, Fu X, Liu L, Liu Y, Zhao H, Li Y, Hu J, Xu L, Liu D, Yang H, Zhang X. Survival benefit of skip metastases in surgically resected N2 non-small cell lung cancer: A multicenter observational study of a large cohort of the Chinese patients. Eur J Surg Oncol. 2020 Oct;46(10 Pt A):1874-1881. doi: 10.1016/j.ejso.2019.12.015. Epub 2019 Dec 18.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Xun Zhang, PhD

    Tianjin Chest Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 12, 2018

Study Start

December 1, 2017

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

May 21, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations