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

NCT ID: NCT04331912

Last Updated: 2021-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2023-12-31

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.

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.

Conditions

Neuroendocrine Tumors

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 87 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Warmia and Mazury

OTHER

Sponsor Role: lead

Responsible Party

Jaroslaw B. Cwikla, MD, PhD, Professor UWM

MD, PhD, Professor UWM

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Warmia and Mazury in Olsztyn

Olsztyn, Warmian-Masurian Voivodeship, Poland

Site Status: RECRUITING

Diagnostic and Therapy Center - Gammed

Warsaw, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Jarosław B Ćwikła, MD, PhD

Role: CONTACT

jbcwikla@interia.pl

+48 602112599

Facility Contacts

Jarosław B Ćwikła, MD, PhD

Role: primary

jbcwikla@interia.pl

+48 602112599

Jarosław B Ćwikła, M.D.

Role: primary

jbcwikla@interia.pl

+48602112599

Alina Czepukojć

Role: backup

gammed@gammed.pl

+48507089942

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Other Identifiers

NEN_2019

Identifier Type: -

Identifier Source: org_study_id