Trial document




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  DRKS00008976

Trial Description

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Title

Peptide receptor radionuclide therapy (PRRT) in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NET) - Evaluation of treatment response and hemato- and nephrotoxicity

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The therapy of neuroendocrine tumors (NET) of the gastrointestinal tracs and pancreas (gastroenteropankreatic NET or GEP-NETs) is usually carried out interdisciplinaryly and depends on the type of tumor and the tumor stage. In early stages, surgery is the therapy of choice. In the case of advanced disease only systemic treatment is usually possible.
Considerable success has been achieved in this case, even after failure of conventional therapies, with peptide receptor radionuclide therapy (PRRT).
In PRRT a radiolabeled peptide binds to the so-called somatostatin receptor, which is expressed on many NET cells. Thus, therapeutic radiation can be brought specifically to the tumor while and non-tumor tissue (having no receptor-expression) is spared.

PRRT has been used since the 90s as a form of tumor specific radiation therapy in the treatment of metastatic or unresectable NET.
By PRRT, further tumor growth is prevented in 40-50% of cases, and a tumor regression is achieved in 30% of cases. The main side effect of PRRT is the radiation exposure of the kidneys and bone marrow and side effects often observed in e.g. chemotherapy such as e.g. nausea and vomiting, are rare.
The response to treatment is monitored by means of so-called tumor markers in the blood and by using imaging modalities.
The tolerability of the therapy (usually 3-5 cycles) is controlled through regular blood counts and determinations of kidney parameters.

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Brief Summary in Scientific Language

PRRT is an established systemic therapy for neuroendocrine tumors. The aim of this retrospective study is to capture the observed kidney function or blood disorders correlated to the applied activities and determined organ doses.
Secondary endpoint is the assessment of treatment response.

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Organizational Data

  •   DRKS00008976
  •   2015/08/20
  •   [---]*
  •   yes
  •   Approved
  •   538/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   Gastroenteropancreatic neuroendocrine Tumors.
  •   C15-C26 -  Malignant neoplasms of digestive organs
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Interventions/Observational Groups

  •   Retrospective assessment of hemato- and nephrotoxicity as well as response to therapy in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NET) receiveing peptide receptor radionuclide therapy (PRRT)retrospective evaluation of therapy data
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Characteristics

  •   Non-interventional
  •   Epidemiological 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

Determination of significant factors influencing nephro- and hematotoxicity of PRRT in patients with gastroenteropancreatic neuroendocrine tumors.

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Secondary Outcome

Assessment of clinical response to PRRT in patients with gastroenteropancreaticneuroendocrine tumors .

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/08/19
  •   111
  •   Monocenter 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 suffering from gastroenteropancreatic neuroendocrine tumors treated by PRRT at the Department of Nuclear Medicine since 2009 will be selected.

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Exclusion Criteria

Patients who received less than 3 cycles of PRRT or patients with incomplete data sets.

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • University Clinic FreiburgDepartment of Nuclear Medicine
    • Mr.  Prof. Dr.  Juri  Ruf 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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    • University Clinic FreiburgDepartment of Nuclear Medicine
    • Mr.  Prof. Dr.  Juri  Ruf 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/02/01
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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.