PFS and OS of Patients With Advanced Neuroendocrine Cancer (NEN) After Systemic Treatment

NCT04331912 | Unknown

• 1 other identifier: NEN_2019
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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

Neuroendocrine Tumors

Keywords

NEN-neuroendocrine cancer, overall survival; OS - overall survival; PFS - progression-free survival

Outcome Measures

Primary Outcomes (2)

• PFS - Progression Free Survival

  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.

  7 years

• OS - Overall Survival

  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.

  7 years

Secondary Outcomes (2)

• Log-rank test

  7 years

• Cox proportional-hazards model

  7 years

Eligibility Criteria

• Age: 18 Years - 87 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study is planned on a group 1500 patients with advanced, histopathologically confirmed neuroendocrine neoplasms (NEN) treated with different schedule of systemic treatment including: somatostatin receptor analogues, molecular targeted therapy (sunitinib or everolimus), chemotherapy using different therapeutic regimens and peptide receptor radioisotope therapy (Peptide Receptor Radionuclide Therapy). Research on NEN patients will include the following groups of patients: 1. NEN from digestive system, 2. respiratory system; 3. Other NEN tumours including PPGL, cancer of known primary and very rare NEN tumours like gynecological or urological primary NET. 4. NEN connected with genetic syndromes like: MEN1, MEN2, VHL, NF1, SDHx.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Warmia and Mazury: lead

Study Sites (2)

University of Warmia and Mazury in Olsztyn

Olsztyn, Warmian-Masurian Voivodeship, 10-082, Poland

RECRUITING

Diagnostic and Therapy Center - Gammed

Warsaw, 02-351, Poland

RECRUITING

Related Publications (20)

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MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Central Study Contacts

Jarosław B Ćwikła, MD, PhD

CONTACT

+48 602112599; jbcwikla@interia.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor UWM

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 2, 2020
• Study Start: July 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: May 13, 2021

Record last verified: 2021-05

Locations

PL (2)