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

Sponsor

Jaroslaw B. Cwikla, MD, PhD, Professor UWM (Other)

Overall Status

Completed

CT.gov ID

NCT03998332

Collaborator

(none)

132

Enrollment

204

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Survival Outcomes of Patients With Pulmonary LCNEC

Detailed Description

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 Design

Study Type:

Observational

Actual Enrollment :

132 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official 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

Actual Study Start Date :

Jan 1, 2002

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Outcome Measures

Primary Outcome Measures

PFS - Progression Free Survival [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.
OS - Overall Survival [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 Outcome Measures

Log-rank test [16 years]
assessment of differences in survival of patients between subgroups
Cox proportional-hazards model [16 years]
multivariate analyses used for investigating the association between the survival time of patients and prognostic factors

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 86 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Jaroslaw B. Cwikla, MD, PhD, Professor UWM

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jaroslaw B. Cwikla, MD, PhD, Professor UWM, Head of Department of Radiology, University of Warmia and Mazury

ClinicalTrials.gov Identifier:

NCT03998332

Other Study ID Numbers:

LCNEC_2018

First Posted:

Jun 26, 2019

Last Update Posted:

Jul 1, 2019

Last Verified:

Jun 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jaroslaw B. Cwikla, MD, PhD, Professor UWM, Head of Department of Radiology, University of Warmia and Mazury

LCNEC-Large cell neuroendocrine carcinoma

Lung cancer

Additional relevant MeSH terms:

Lung Neoplasms

Study Results

No Results Posted as of Jul 1, 2019