Trial document




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  DRKS00005433

Trial Description

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Title

Non-Interventional Study to Assess the Clinical Outcome in Patients Treated for Poorly Differentiated (High-Grade, G3) Neuroendocrine Carcinomas Except Primary Lung Cancer

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Trial Acronym

OSHO #087

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URL of the Trial

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Brief Summary in Lay Language

This registry shall determine the clinical presentation, diagnosis and treatment course(s) of patients with poorly differentiated G3 neuroendocrine carcinomas following current treatment standards and second-line options.

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Brief Summary in Scientific Language

Since 1991, there has been no substantial progress in the treatment algorithms and no improvement of overall survival in patients with G3 neuroendocrine carcinomas. Cis- or carboplatin in combination with etoposide is an accepted standard for systemic first-line treatment, however, second-line and salvage treatment options are not defined, nor are antineoplastic agents used in this setting approved for this indication. A retrospective data review with the OSHO has shown that low-grade (G1, G2) neuroendocrine tumors are sometimes treated aggressively, according to regimens recommended for aggressive (G3) NEC, and vice versa. A proposal of accepted treatment regimens shall help to better manage these patients, and standardized documentation forms shall help to assess the efficacy of established treatment approaches given to these patients in one of the numerous oncological institutions within the OSHO.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005433
  •   2013/11/12
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  •   yes
  •   No approval required according to EC
  •   [---]*, Ethik-Kommission der Landesärztekammer Brandenburg
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Secondary IDs

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Health Condition or Problem studied

  •   Poorly differentiated (G3) neuroendocrine carcinomas except primary lung cancer
  •   C75.9 -  Malignant neoplasm: Endocrine gland, unspecified
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Interventions/Observational Groups

  •   Registry for deidentified documentation of clinical data (stage, histology, tumor site, first-line treatment, second-line treatment, side effects)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Overall survival after first diagnosis

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Secondary Outcome

Response to primary and salvage treatment regimens; progression-free survival, treatment-related adverse events

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2014/05/30
  •   50
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients with poorly differentiated (G3) neuroendocrine carcinoma except primary lung cancer

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Exclusion Criteria

primary lung cancer G3

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Addresses

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    • OSHO,Ostdeutsche Studiengruppe für Hämatologie und Onkologie
    • Ms. 
    • Johannisallee 32A
    • 04103  Leipzig
    • Germany
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    • Klinikum Ernst von BergmannKlinik für Hämatologie, Onkologie und Palliativmedizin
    • Mr.  Prof. Dr.  Georg  Maschmeyer 
    • Charlottenstrasse 72
    • 14467  Potsdam
    • Germany
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    • Universitätsklinikum Leipzig, Abteilung für Hämatologie und internistische Onkologie
    • Ms.  Sandra  Otto 
    • Johannisallee 32A
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • OSHO, Ostdeutsche Studiengruppe für Hämatologie und Onkologie
    • Johannisallee 23a
    • 04103  Leipzig
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.