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

June 27, 2019 updated by: Jaroslaw B. Cwikla, MD, PhD, Professor UWM

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 86 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • Adults ≥18 years old, male or female, with pathologically confirmed primary neuroendocrine lung cancer based on histopathological examination:

    1. LCNEC
    2. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 years
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.
16 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Log-rank test
Time Frame: 16 years
assessment of differences in survival of patients between subgroups
16 years
Cox proportional-hazards model
Time Frame: 16 years
multivariate analyses used for investigating the association between the survival time of patients and prognostic factors
16 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaroslaw B. Cwikla, MD, PhD, Professor UWM

Investigators

  • Study Chair: Jarosław B Ćwikła, MD, PhD, University of Warmia and Mazury

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2002

Primary Completion (ACTUAL)

December 31, 2018

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

June 18, 2019

First Submitted That Met QC Criteria

June 23, 2019

First Posted (ACTUAL)

June 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 1, 2019

Last Update Submitted That Met QC Criteria

June 27, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCNEC_2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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