Survival Outcomes of Patients With Pulmonary LCNEC Clinical Trial
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
| Verified date | June 2019 |
| Source | University of Warmia and Mazury |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 132 |
| Est. completion date | December 31, 2018 |
| Est. primary completion date | December 31, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 86 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Jaroslaw B. Cwikla, MD, PhD, Professor UWM |
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | PFS - Progression Free Survival | 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 | |
| Primary | OS - Overall Survival | 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 | Log-rank test | assessment of differences in survival of patients between subgroups | 16 years | |
| Secondary | Cox proportional-hazards model | multivariate analyses used for investigating the association between the survival time of patients and prognostic factors | 16 years |