Survival Outcomes of Patients With Pulmonary LCNECNCT03998332
Overall Survival of Large Cell Neuroendocrine Lung Cancer Patients - a Retrospective Study
An observational study of Survival Outcomes of Patients With Pulmonary LCNEC, run by Jaroslaw B. Cwikla, MD, PhD, Professor UWM.
Trial 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%). Read more about this study
- Who is it for?
- Ages 18 to 86 years
- Conditions the study is for
- Survival Outcomes of Patients With Pulmonary LCNEC
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2002to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- NA
About this 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
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.
- Keywords
- LCNEC-Large cell neuroendocrine carcinoma, Lung cancer
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 years
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.
Measured: 16 years
Secondary outcomes (2)
Log-rank test
assessment of differences in survival of patients between subgroups
Measured: 16 years
Cox proportional-hazards model
multivariate analyses used for investigating the association between the survival time of patients and prognostic factors
Measured: 16 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start1 Jan 2002
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Survival Outcomes of Patients With Pulmonary LCNECStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaroslaw B. Cwikla, MD, PhD, Professor UWM
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jaroslaw B. Cwikla, MD, PhD, Professor UWM, University of Warmia and Mazury
- Investigators
- Jarosław B Ćwikła, MD, PhD, Study chair, University of Warmia and Mazury
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998332
- Sponsor's protocol ID
- LCNEC_2018
- Status last verified
- Jun 2019
- First submitted
- 18 Jun 2019
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 21043816Travis WD. Advances in neuroendocrine lung tumors. Ann Oncol. 2010 Oct;21 Suppl 7:vii65-71. doi: 10.1093/annonc/mdq380.
PubMed 20943645Gustafsson 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 18473355Detterbeck FC. Management of carcinoid tumors. Ann Thorac Surg. 2010 Mar;89(3):998-1005. doi: 10.1016/j.athoracsur.2009.07.097.
PubMed 20172187Wolin 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 26306904Chong 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 25218177Modlin 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 18177818Modlin 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 12569593Yao 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 18565894Vinik 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 20664471Oberg 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 22997444Caplin 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 25646366Fisseler-Eckhoff A, Demes M. Neuroendocrine tumors of the lung. Cancers (Basel). 2012 Jul 31;4(3):777-98. doi: 10.3390/cancers4030777.
PubMed 24213466Detterbeck 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 25065927Pieterman 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03998332
- Acronym / sponsor ID
- LCNEC_2018
- Keywords
- LCNEC-Large cell neuroendocrine carcinoma, Lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Jaroslaw B. Cwikla, MD, PhD, Professor UWMUniversity, hospital or other
- Study start
- 1 Jan 2002 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Adults ≥18 years old, male or female, with pathologically confirmed primary neuroendocrine lung cancer based on histopathological examination:
- 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
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
2 secondary outcomes
Log-rank test
Time frame: 16 years
Cox proportional-hazards model
Time frame: 16 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Results publication: PubMed 21043816Rekhtman 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.
- Results publication: PubMed 20943645Travis WD. Advances in neuroendocrine lung tumors. Ann Oncol. 2010 Oct;21 Suppl 7:vii65-71. doi: 10.1093/annonc/mdq380.
- Results publication: PubMed 18473355Gustafsson 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.
- Results publication: PubMed 20172187Detterbeck FC. Management of carcinoid tumors. Ann Thorac Surg. 2010 Mar;89(3):998-1005. doi: 10.1016/j.athoracsur.2009.07.097.
- Results publication: PubMed 26306904Wolin 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.
- Results publication: PubMed 25218177Chong 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.
- Results publication: PubMed 18177818Modlin 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.
- Results publication: PubMed 12569593Modlin 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.
- Results publication: PubMed 18565894Yao 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.
- Results publication: PubMed 20664471Vinik 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.
- Results publication: PubMed 22997444Oberg 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.
- Results publication: PubMed 25646366Caplin 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jarosław B Ćwikła, MD, PhD study chair
University of Warmia and Mazury
Questions about this trial
What is this clinical trial studying?
An observational study of Survival Outcomes of Patients With Pulmonary LCNEC, run by Jaroslaw B. Cwikla, MD, PhD, Professor UWM.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS - Progression Free Survival (time frame: 16 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03998332, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2019.