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Trial record 42 of 913 for:    Advanced | Neuroendocrine Tumors

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04331912
Recruitment Status : Active, not recruiting
First Posted : April 2, 2020
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
Jaroslaw B. Cwikla, MD, PhD, Professor UWM, University of Warmia and Mazury

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.

Condition or disease
Neuroendocrine Tumors

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.

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Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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.
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Log-rank test [ Time Frame: 7 years ]
    assessment of differences in survival of patients between subgroups

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 87 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04331912


Locations
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Poland
University of Warmia and Mazury in Olsztyn
Olsztyn, Warmińsko-Mazurskie, Poland, 10-082
Sponsors and Collaborators
University of Warmia and Mazury
Publications of Results:

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Responsible Party: Jaroslaw B. Cwikla, MD, PhD, Professor UWM, MD, PhD, Professor UWM, University of Warmia and Mazury
ClinicalTrials.gov Identifier: NCT04331912    
Other Study ID Numbers: NEN_2019
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jaroslaw B. Cwikla, MD, PhD, Professor UWM, University of Warmia and Mazury:
NEN-neuroendocrine cancer, overall survival
OS - overall survival
PFS - progression-free survival
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Carcinoma, Neuroendocrine
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial