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CompletedNCT03998332Updated Jul 1, 2019

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

An observational study in Survival Outcomes of Patients With Pulmonary LCNEC, sponsored by Jaroslaw B. Cwikla, MD, PhD, Professor UWM. Completed. Open to participants aged 18 Years to 86 Years. Per ClinicalTrials.gov, last updated 2019-07-01.

Sponsored by Jaroslaw B. Cwikla, MD, PhD, Professor UWM · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
132
Ages
18 Years to 86 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Survival Outcomes of Patients With Pulmonary LCNEC

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Keywords

  • LCNEC-Large cell neuroendocrine carcinoma
  • Lung cancer
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 132 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

This is the only study on the registry with Jaroslaw B. Cwikla, MD, PhD, Professor UWM as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 86 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • NA
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
132 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 16 years

  2. 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.

    Time frame: 16 years

Secondary outcomes

  1. Log-rank test

    assessment of differences in survival of patients between subgroups

    Time frame: 16 years

  2. Cox proportional-hazards model

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

    Time frame: 16 years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Rekhtman N. Neuroendocrine tumors of the lung: an update. Arch Pathol Lab Med. 2010 Nov;134(11):1628-38. doi: 10.5858/2009-0583-RAR.1. PubMed 21043816 ↗
  • Travis WD. Advances in neuroendocrine lung tumors. Ann Oncol. 2010 Oct;21 Suppl 7:vii65-71. doi: 10.1093/annonc/mdq380. PubMed 20943645 ↗
  • Gustafsson BI, Kidd M, Chan A, Malfertheiner MV, Modlin IM. Bronchopulmonary neuroendocrine tumors. Cancer. 2008 Jul 1;113(1):5-21. doi: 10.1002/cncr.23542. PubMed 18473355 ↗
  • Detterbeck FC. Management of carcinoid tumors. Ann Thorac Surg. 2010 Mar;89(3):998-1005. doi: 10.1016/j.athoracsur.2009.07.097. PubMed 20172187 ↗
  • Wolin EM. Challenges in the Diagnosis and Management of Well-Differentiated Neuroendocrine Tumors of the Lung (Typical and Atypical Carcinoid): Current Status and Future Considerations. Oncologist. 2015 Oct;20(10):1123-31. doi: 10.1634/theoncologist.2015-0198. Epub 2015 Aug 25. PubMed 26306904 ↗
  • Chong CR, Wirth LJ, Nishino M, Chen AB, Sholl LM, Kulke MH, McNamee CJ, Janne PA, Johnson BE. Chemotherapy for locally advanced and metastatic pulmonary carcinoid tumors. Lung Cancer. 2014 Nov;86(2):241-6. doi: 10.1016/j.lungcan.2014.08.012. Epub 2014 Aug 27. PubMed 25218177 ↗
  • Modlin IM, Oberg K, Chung DC, Jensen RT, de Herder WW, Thakker RV, Caplin M, Delle Fave G, Kaltsas GA, Krenning EP, Moss SF, Nilsson O, Rindi G, Salazar R, Ruszniewski P, Sundin A. Gastroenteropancreatic neuroendocrine tumours. Lancet Oncol. 2008 Jan;9(1):61-72. doi: 10.1016/S1470-2045(07)70410-2. PubMed 18177818 ↗
  • Modlin IM, Lye KD, Kidd M. A 5-decade analysis of 13,715 carcinoid tumors. Cancer. 2003 Feb 15;97(4):934-59. doi: 10.1002/cncr.11105. PubMed 12569593 ↗
  • Yao JC, Hassan M, Phan A, Dagohoy C, Leary C, Mares JE, Abdalla EK, Fleming JB, Vauthey JN, Rashid A, Evans DB. One hundred years after "carcinoid": epidemiology of and prognostic factors for neuroendocrine tumors in 35,825 cases in the United States. J Clin Oncol. 2008 Jun 20;26(18):3063-72. doi: 10.1200/JCO.2007.15.4377. PubMed 18565894 ↗
  • Vinik AI, Woltering EA, Warner RR, Caplin M, O'Dorisio TM, Wiseman GA, Coppola D, Go VL; North American Neuroendocrine Tumor Society (NANETS). NANETS consensus guidelines for the diagnosis of neuroendocrine tumor. Pancreas. 2010 Aug;39(6):713-34. doi: 10.1097/MPA.0b013e3181ebaffd. No abstract available. PubMed 20664471 ↗
  • Oberg K, Hellman P, Ferolla P, Papotti M; ESMO Guidelines Working Group. Neuroendocrine bronchial and thymic tumors: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2012 Oct;23 Suppl 7:vii120-3. doi: 10.1093/annonc/mds267. No abstract available. PubMed 22997444 ↗
  • Caplin ME, Baudin E, Ferolla P, Filosso P, Garcia-Yuste M, Lim E, Oberg K, Pelosi G, Perren A, Rossi RE, Travis WD; ENETS consensus conference participants. Pulmonary neuroendocrine (carcinoid) tumors: European Neuroendocrine Tumor Society expert consensus and recommendations for best practice for typical and atypical pulmonary carcinoids. Ann Oncol. 2015 Aug;26(8):1604-20. doi: 10.1093/annonc/mdv041. Epub 2015 Feb 2. PubMed 25646366 ↗
  • Fisseler-Eckhoff A, Demes M. Neuroendocrine tumors of the lung. Cancers (Basel). 2012 Jul 31;4(3):777-98. doi: 10.3390/cancers4030777. PubMed 24213466 ↗
  • Detterbeck FC. Clinical presentation and evaluation of neuroendocrine tumors of the lung. Thorac Surg Clin. 2014 Aug;24(3):267-76. doi: 10.1016/j.thorsurg.2014.04.002. PubMed 25065927 ↗
  • Pieterman CR, Conemans EB, Dreijerink KM, de Laat JM, Timmers HT, Vriens MR, Valk GD. Thoracic and duodenopancreatic neuroendocrine tumors in multiple endocrine neoplasia type 1: natural history and function of menin in tumorigenesis. Endocr Relat Cancer. 2014 May 6;21(3):R121-42. doi: 10.1530/ERC-13-0482. Print 2014 Jun. PubMed 24389729 ↗
  • Aguayo SM, Miller YE, Waldron JA Jr, Bogin RM, Sunday ME, Staton GW Jr, Beam WR, King TE Jr. Brief report: idiopathic diffuse hyperplasia of pulmonary neuroendocrine cells and airways disease. N Engl J Med. 1992 Oct 29;327(18):1285-8. doi: 10.1056/NEJM199210293271806. No abstract available. PubMed 1406819 ↗
  • Gosney JR. Diffuse idiopathic pulmonary neuroendocrine cell hyperplasia as a precursor to pulmonary neuroendocrine tumors. Chest. 2004 May;125(5 Suppl):108S. doi: 10.1378/chest.125.5_suppl.108s. No abstract available. PubMed 15136447 ↗
  • Koo CW, Baliff JP, Torigian DA, Litzky LA, Gefter WB, Akers SR. Spectrum of pulmonary neuroendocrine cell proliferation: diffuse idiopathic pulmonary neuroendocrine cell hyperplasia, tumorlet, and carcinoids. AJR Am J Roentgenol. 2010 Sep;195(3):661-8. doi: 10.2214/AJR.09.3811. PubMed 20729444 ↗
  • Chong S, Lee KS, Chung MJ, Han J, Kwon OJ, Kim TS. Neuroendocrine tumors of the lung: clinical, pathologic, and imaging findings. Radiographics. 2006 Jan-Feb;26(1):41-57; discussion 57-8. doi: 10.1148/rg.261055057. PubMed 16418242 ↗
  • Travis WD, Rush W, Flieder DB, Falk R, Fleming MV, Gal AA, Koss MN. Survival analysis of 200 pulmonary neuroendocrine tumors with clarification of criteria for atypical carcinoid and its separation from typical carcinoid. Am J Surg Pathol. 1998 Aug;22(8):934-44. doi: 10.1097/00000478-199808000-00003. PubMed 9706973 ↗
  • Igawa S, Watanabe R, Ito I, Murakami H, Takahashi T, Nakamura Y, Tsuya A, Kaira K, Naito T, Endo M, Yamamoto N, Kameya T. Comparison of chemotherapy for unresectable pulmonary high-grade non-small cell neuroendocrine carcinoma and small-cell lung cancer. Lung Cancer. 2010 Jun;68(3):438-45. doi: 10.1016/j.lungcan.2009.07.003. Epub 2009 Aug 21. PubMed 19699548 ↗
  • Watanabe R, Ito I, Kenmotsu H, Endo M, Yamamoto N, Ohde Y, Kondo H, Nakajima T, Kameya T. Large cell neuroendocrine carcinoma of the lung: is it possible to diagnose from biopsy specimens? Jpn J Clin Oncol. 2013 Mar;43(3):294-304. doi: 10.1093/jjco/hys221. Epub 2013 Feb 3. PubMed 23381206 ↗
  • Kujtan L, Muthukumar V, Kennedy KF, Davis JR, Masood A, Subramanian J. The Role of Systemic Therapy in the Management of Stage I Large Cell Neuroendocrine Carcinoma of the Lung. J Thorac Oncol. 2018 May;13(5):707-714. doi: 10.1016/j.jtho.2018.01.019. Epub 2018 Jan 31. PubMed 29391287 ↗
  • Hiroshima K, Mino-Kenudson M. Update on large cell neuroendocrine carcinoma. Transl Lung Cancer Res. 2017 Oct;6(5):530-539. doi: 10.21037/tlcr.2017.06.12. PubMed 29114469 ↗
  • Yang G, Pan Z, Ma N, Qu L, Yuan T, Pang X, Yang X, Dong L, Liu S. Leptomeningeal metastasis of pulmonary large-cell neuroendocrine carcinoma: A case report and review of the literature. Oncol Lett. 2017 Oct;14(4):4282-4286. doi: 10.3892/ol.2017.6676. Epub 2017 Jul 26. PubMed 28943940 ↗
  • Ramirez RA, Chauhan A, Gimenez J, Thomas KEH, Kokodis I, Voros BA. Management of pulmonary neuroendocrine tumors. Rev Endocr Metab Disord. 2017 Dec;18(4):433-442. doi: 10.1007/s11154-017-9429-9. PubMed 28868578 ↗
  • Tang H, Wang H, Xi S, He C, Chang Y, Wang Q, Wu Y. Perioperative chemotherapy with pemetrexed and cisplatin for pulmonary large-cell neuroendocrine carcinoma: a case report and literature review. Onco Targets Ther. 2018 May 7;11:2557-2563. doi: 10.2147/OTT.S160565. eCollection 2018. PubMed 29765234 ↗
  • Derks JL, van Suylen RJ, Thunnissen E, den Bakker MA, Groen HJ, Smit EF, Damhuis RA, van den Broek EC, Speel EM, Dingemans AC; PALGA group. Chemotherapy for pulmonary large cell neuroendocrine carcinomas: does the regimen matter? Eur Respir J. 2017 Jun 1;49(6):1601838. doi: 10.1183/13993003.01838-2016. Print 2017 Jun. PubMed 28572122 ↗
  • Prelaj A, Rebuzzi SE, Del Bene G, Giron Berrios JR, Emiliani A, De Filippis L, Prete AA, Pecorari S, Manna G, Ferrara C, Rossini D, Longo F. Evaluation of the efficacy of cisplatin-etoposide and the role of thoracic radiotherapy and prophylactic cranial irradiation in LCNEC. ERJ Open Res. 2017 Mar 29;3(1):00128-2016. doi: 10.1183/23120541.00128-2016. eCollection 2017 Jan. PubMed 28382303 ↗
  • Kim KW, Kim HK, Kim J, Shim YM, Ahn MJ, Choi YL. Outcomes of Curative-Intent Surgery and Adjuvant Treatment for Pulmonary Large Cell Neuroendocrine Carcinoma. World J Surg. 2017 Jul;41(7):1820-1827. doi: 10.1007/s00268-017-3908-8. PubMed 28204910 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03998332
Lead sponsor
Jaroslaw B. Cwikla, MD, PhD, Professor UWM
Responsible party
Jaroslaw B. Cwikla, MD, PhD, Professor UWM (Head of Department of Radiology, University of Warmia and Mazury) — Sponsor-investigator
First posted
Jun 26, 2019
Start date
Jan 1, 2002
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Jul 1, 2019

Study contacts

Jarosław B Ćwikła, MD, PhD
study chair · University of Warmia and Mazury

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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