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Completed

NCT Number: NCT03998332

Overall Survival of Large Cell Neuroendocrine Lung Cancer Patients - a Retrospective Study

This is a retrospective study. 132 patients with LCNEC and combined LCNEC were included to the analysis. Patients were treated with radical, palliative or symptomatic intension between 2002-2018 in central and north-eastern centres in Poland. The group of patients consists of 47 women (36%) and 85 men (64%). Ratio of women to men is 1:1,81. The observation period ranged from 0 to 192 months.

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Key information

About this study

This is a retrospective study. 132 patients with LCNEC and combined LCNEC were included to the analysis. Patients were treated with radical, palliative or symptomatic intension between 2002-2018 in central and north-eastern centres in Poland. The group of patients consists of 47 women (36%) and 85 men (64%). Ratio of women to men is 1:1,81. The observation period ranged from 0 to 192 months.

For all patients included to the analysis, the clinical stage was estimated according to TNM Classification of Malignant Tumours - UICC from 2017. The degree of pathomorphic stage (pTNM) was assessed in 60 patients treated with intention to treat (ITT), which is 45% of the total population.

The degree of clinical stage (cTNM) was assessed in 72 patients based on the imaging examinations (including PET, CT, MRI, bone scintigraphy, etc.) and fine needle aspiration biopsy (FNA) (including EBUS, with pathological confirmation of LCNEC, which is 55% of the total population.

The clinical stage (cTNM) was used in case of patients disqualified from radical surgery due to: advanced disease, contraindications to surgery, no patient's consent for treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults ≥18 years old, male or female, with pathologically confirmed primary neuroendocrine lung cancer based on histopathological examination:
  • LCNEC
  • combined type LCNEC
  • Patients with LCNEC, combined LCNEC without prior treatment independently from the clinical stage according to the 8th edition of TNM 2017
  • Patients with generalized, unresectable of LCNEC, combined LCNEC before, during and after palliative treatment
  • Patients with generalized, unresectable LCNEC, combined LCNEC treated only symptomatically
  • Patients with locally advanced, unresectable LCNEC,combined LCNEC before, during and after radical treatment
  • Patients with locally advanced, resectable LCNEC, combined LCNEC before, during and after treatment

Exclusion criteria

  • NA

Treatment and study plan

Primary outcomes

  1. PFS - Progression Free Survival

    Time frame: 16 years

    the time from the start of treatment date to the date of first observation of documented local recurrence, metastases or disease progression. Patients without progression at the time of analysis will be censored.

  2. OS - Overall Survival

    Time frame: 16 years

    is defined as the time from the histopathological confirmation to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.

Secondary outcomes

  1. Log-rank test

    Time frame: 16 years

    assessment of differences in survival of patients between subgroups

  2. Cox proportional-hazards model

    Time frame: 16 years

    multivariate analyses used for investigating the association between the survival time of patients and prognostic factors

Sponsors and collaborators

Lead sponsor

Jaroslaw B. Cwikla, MD, PhD, Professor UWM

Other

Registry information

Official study title

Overall Survival and Progression Free Survival of Patients With Large Cell Neuroendocrine Lung Cancer and Combined Large Cell Neuroendocrine Lung Cancer Treated in Clinical Stage I-IV

Important dates

Study start
2002
Primary completion
2018
Study completion
2018
First posted
Jun 26, 2019
Registry last updated
Jul 1, 2019

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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