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Completed

NCT Number: NCT03451526

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

China PLA General Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Surgeries

Procedure

Surgeries plus adjuvant chemotherapies or perioperative chemotherapies

Other names: Adjuvant chemotherapies or perioperative chemotherapies

Primary outcomes

  1. Overall survival

    Time frame: 2014 - 2017

    Overall survival

Secondary outcomes

  1. Disease-free survival

    Time frame: 2014 - 2017

    Disease-free survival

Other outcomes

  1. Overall survivals in the subgroups

    Time frame: 2014 - 2017

    Overall survivals in the subgroups categorized by T staging

  2. Disease-free survivals in the subgroups

    Time frame: 2014 - 2017

    Disease-free survivals in the subgroups categorized by T staging

  3. Impact factors of overall survival as measured by age

    Time frame: 2014 - 2017

    Impact factors of overall survival as measured by age

  4. Impact factors of overall survival as measured by gender

    Time frame: 2014 - 2017

    Impact factors of overall survival as measured by gender

  5. Impact factors of overall survival as measured by BMI

    Time frame: 2014 - 2017

    Impact factors of overall survival as measured by BMI

  6. Impact factors of overall survival as measured by tumor size

    Time frame: 2014 - 2017

    Impact factors of overall survival as measured by tumor size

  7. Impact factors of overall survival as measured by tumor location

    Time frame: 2014 - 2017

    Impact factors of overall survival as measured by tumor location

  8. Impact factors of overall survival as measured by T staging

    Time frame: 2014 - 2017

    Impact factors of overall survival as measured by T staging

  9. Impact factors of overall survival as measured by clinical treatments

    Time frame: 2014 - 2017

    Impact factors of overall survival as measured by surgeries plus adjuvant chemotherapies and surgeries plus perioperative chemotherapies

  10. Time to local recurrence

    Time frame: 2014 - 2017

    Time to local recurrence

  11. Time to distant recurrence

    Time frame: 2014 - 2017

    Time to distant recurrence

  12. Death rate within 30/90 days after surgeries

    Time frame: 2014 - 2017

    Death rate within 30/90 days after surgeries

  13. Impact factors of death rate within 30/90 days after surgeries as measured by patient demographic characteristics

    Time frame: 2014 - 2017

    Impact factors of death rate within 30/90 days after surgeries as measured by patient demographic characteristics

  14. Impact factors of death rate within 30/90 days after surgeries as measured by tumor biological characteristics

    Time frame: 2014 - 2017

    Impact factors of death rate within 30/90 days after surgeries as measured by tumor biological characteristics

  15. Impact factors of death rate within 30/90 days after surgeries as measured by various modes of surgeries

    Time frame: 2014 - 2017

    Impact factors of death rate within 30/90 days after surgeries as measured by various modes of surgeries

  16. Incidence of perioperative complications

    Time frame: 2014 - 2017

    Incidence of perioperative complications

Sponsors and collaborators

Lead sponsor

Tang-Du Hospital

Other

Collaborators

  • LinkDoc Technology (Beijing) Co. Ltd.

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Mar 1, 2018
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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