Clinical trial NCT03998332: Overall Survival of Large Cell Neuroendocrine Lung Cancer Patients - a Retrospective Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Survival Outcomes of Patients With Pulmonary LCNEC
Keywords: LCNEC-Large cell neuroendocrine carcinoma
Lung cancer
Lead sponsor: University of Warmia and Mazury
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: PFS - Progression Free Survival
timeFrame: 16 years
measure: OS - Overall Survival
timeFrame: 16 years
Secondary outcomes:
measure: Log-rank test
timeFrame: 16 years
measure: Cox proportional-hazards model
timeFrame: 16 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Warmia and Mazury
name: Jarosław B Ćwikła, MD, PhD
role: STUDY_CHAIR
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