Clinical trial · Observational
PFS and OS of Patients With Advanced Neuroendocrine Cancer (NEN) After Systemic Treatment
Outcomes of Patients With Advanced Neuroendocrine Cancer (NEN) Treated With Systemic Treatment: Somatostatin Analogues, Molecular Targeted Therapy, Chemotherapy and Peptide Radioisotope Therapy - a Retrospective Analysis.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a retrospective study. The analysis includes patients with advanced neuroendocrine cancer (NEN) treated with systemic therapy, because of inoperable primary tumor or/and metastasis, clinical, imaging, biochemical disease progression and no standard method of treatment hormone overproduction symptoms. The data of patients with advanced NEN with histopathological confirmation is collected from medical records. The progression-free survival (PFS), overall survival (OS) and influence of various factors on survival will be estimated. The research will be conducted for above 3 years on planned group 1500 patients. The aim of the study is to estimate median OS and PFS in advanced NEN patients treated with different schedule of systemic treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- PFS - Progression Free Survival
- timeFrame
- 7 years
- description
- the time from the start of systemic treatment date to the date of first documented disease progression (event: disease progression - DP, based on RECIST, death, adverse events, which provide to disqualification from further therapy). Patients without progression at the time of analysis will be censored.
- measure
- OS - Overall Survival
- timeFrame
- 7 years
- description
- is defined as the time from the start of systemic treatment date 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 outcomes (2)
- measure
- Log-rank test
- timeFrame
- 7 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 87 Years
Show eligibility criteria text
Inclusion Criteria: * Adults ≥18 years old, male or female, * Patients with histopathological confirmation of advanced neuroendocrine cancer (NEN), * Patients with NETG1, NETG2 based on Ki-67, * Patients with diagnosed NEN, who did not receive prior treatment and were qualified to systemic treatment, * Patients with advanced NEN who previously received first-line systemic therapy or second-line systemic therapy, * Patients with advanced, inoperable NEN cancer before the treatment, during the treatment and after the treatment regardless of lines of systemic therapy, * Patients with diagnosed NEN and performance status (PS) ≤3 according to ECOG/WHO classification, who received systemic therapy. Exclusion Criteria: * Patients without histopathological confirmation of neuroendocrine carcinoma (NEN), * Patients with diagnosed another type of cancer or benign tumor confirmed in histopathological examination, * Patients treated prior with intention to treat (ITT), * Patients with residual disease in further clinical follow-up without active systemic treatment, * Patients with advanced, progressive and poor performance status, who were disqualified from further systemic treatment, * Patients, who finished treatment during first month or their further disease process was unknown.
References
Publications (20)
- RESULTModlin IM, Shapiro MD, Kidd M. Siegfried Oberndorfer: origins and perspectives of carcinoid tumors. Hum Pathol. 2004 Dec;35(12):1440-51. doi: 10.1016/j.humpath.2004.09.018. PMID 15619202
- RESULTModlin 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. PMID 18177818
- RESULTModlin IM, Champaneria MC, Bornschein J, Kidd M. Evolution of the diffuse neuroendocrine system--clear cells and cloudy origins. Neuroendocrinology. 2006;84(2):69-82. doi: 10.1159/000096997. Epub 2006 Nov 9. PMID 17106184
- RESULTModlin 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. PMID 12569593
- RESULTKloppel G, Perren A, Heitz PU. The gastroenteropancreatic neuroendocrine cell system and its tumors: the WHO classification. Ann N Y Acad Sci. 2004 Apr;1014:13-27. doi: 10.1196/annals.1294.002. PMID 15153416
- RESULTGreene FL. TNM staging for malignancies of the digestive tract: 2003 changes and beyond. Semin Surg Oncol. 2003;21(1):23-9. doi: 10.1002/ssu.10018. PMID 12923913
- RESULTKloppel G, Rindi G, Perren A, Komminoth P, Klimstra DS. The ENETS and AJCC/UICC TNM classifications of the neuroendocrine tumors of the gastrointestinal tract and the pancreas: a statement. Virchows Arch. 2010 Jun;456(6):595-7. doi: 10.1007/s00428-010-0924-6. Epub 2010 Apr 27. No abstract available. PMID 20422210
- RESULTWashington MK, Tang LH, Berlin J, Branton PA, Burgart LJ, Carter DK, Compton CC, Fitzgibbons PL, Frankel WL, Jessup JM, Kakar S, Minsky B, Nakhleh RE; Members of the Cancer Committee, College of American Pathologists. Protocol for the examination of specimens from patients with neuroendocrine tumors (carcinoid tumors) of the small intestine and ampulla. Arch Pathol Lab Med. 2010 Feb;134(2):181-6. doi: 10.5858/134.2.181. No abstract available.