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

May 12, 2021 updated by: Jaroslaw B. Cwikla, MD, PhD, Professor UWM, University of Warmia and Mazury

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.

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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. Systemic treatment including: somatostatin receptor analogues, molecular targeted therapy (sunitinib and everolimus), chemotherapy and peptide radioisotope therapy (Peptide Receptor Radionuclide Therapy). The data of patients with advanced NEN with histopathological or/and clinical or/and biochemical confirmation is collected from medical records. Neuroendocrine cancer from digestive system, respiratory system and another rarely occurring cancer including cancer connected with genetic syndromes like: MEN1, MEN2, VHL, NF1, SDHx will be included. The progression-free survival (PFS), overall survival (OS) and influence of various factors on survival will be estimated. Analyzed factors: age, sex, ethnicity, specific symptoms at the time of diagnosis, carcinoid heart disease, level of 5HIAA in DZM, level of CgA, liver test, size of tumor, cell differentiation of tumor based on Ki-67 index, liver metastases. The research will be conducted for above 3 years since July 2019 till December 2022 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. The second goal is to create clinical practice recommendation based on potential prognostic factors of OS and PFS due to type of therapy in different NEN subgroups.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Warsaw, Poland, 02-351
        • Recruiting
        • Diagnostic and Therapy Center - Gammed
        • Contact:
        • Contact:
    • Warmińsko-Mazurskie
      • Olsztyn, Warmińsko-Mazurskie, Poland, 10-082
        • Recruiting
        • University of Warmia and Mazury in Olsztyn
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 87 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS - Progression Free Survival
Time Frame: 7 years
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
Time Frame: 7 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Log-rank test
Time Frame: 7 years
assessment of differences in survival of patients between subgroups
7 years
Cox proportional-hazards model
Time Frame: 7 years
uni- and multivariate analyses used for investigating the association between the survival time of patients and prognostic factors
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Warmia and Mazury

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 31, 2020

First Submitted That Met QC Criteria

March 31, 2020

First Posted (Actual)

April 2, 2020

Study Record Updates

Last Update Posted (Actual)

May 13, 2021

Last Update Submitted That Met QC Criteria

May 12, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEN_2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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