Trial document




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  DRKS00017368

Trial Description

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Title

NIRACTIV-NIRaparib health research study to evaluate quality of life and ACTIVity in patients undergoing maintenance therapy in ovarian cancer

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Non-interventional, observational study with baseline documentation and treatment documentation every four weeks from last two cycles of chemotherapy and 3 months of Niraparib treatment in patients with ovarian cancer (OC).

In addition, a sub-study named NIRvertical is planned (about 30 patients in 2 sites) with patients who use the activity tracker already before first chemotherapy cycle (start from diagnosis of first relapse; 15 patients with surgery and 15 patients without surgery) until 3 months of Niraparib treatment (longitudinal measurement).

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Brief Summary in Scientific Language

Non-interventional, observational study with baseline documentation and treatment documentation every four weeks from last two cycles of chemotherapy and 3 months of Niraparib treatment in patients with ovarian cancer (OC).

In addition, a sub-study named NIRvertical is planned (about 30 patients in 2 sites) with patients who use the activity tracker already before first chemotherapy cycle (start from diagnosis of first relapse; 15 patients with surgery and 15 patients without surgery) until 3 months of Niraparib treatment (longitudinal measurement).

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Organizational Data

  •   DRKS00017368
  •   2019/05/22
  •   [---]*
  •   yes
  •   Approved
  •   EA4/185/18, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   C56 -  Malignant neoplasm of ovary
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Interventions/Observational Groups

  •   The aim of this study is to measure activity during chemotherapy and subsequent maintenance therapy with Niraparib and the effects of the drug on quality of life. Various questionnaires and a fitness tracker are used for this purpose. The questionnaires are the so-called Fatigue FACT-F questionnaire, SF-12 questionnaire, PRO CTCAE and EORTC QLQ-C30 and OVC28 questionnaire; all standardized questionnaires on general health. There is also a questionnaire that has been specially compiled for the study.

    Each patient is individually documented on her treatment and medical history from the 5th chemotherapy cycle and during the subsequent first 3 months of Niraparib maintenance therapy. Depending on the treatment regimen, medical data is collected and documented approximately every 21-28 days. This is done during the routine examination. All patients are requested to wear a fitness bracelet "Activity Tracker" daily.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

• Assessment of activity levels over the entire observation period (chemotherapy and maintenance therapy phase with niraparib)
• The data are collected at each visit from the 5th cycle of chemotherapy until the end of the 3-month niraparib treatment and evaluated after the follow-up (after 3 and 6 months). This corresponds to a total observation period of approx. 1 year
• For each visit, patients complete questionnaires (SF-12, FACT-F, QLQ-C30 & OV28, PRO CTCAE) and carry an "Activity Tracker" throughout the entire observation period

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Secondary Outcome

• Evaluation or comparison of changes in QoL in the chemotherapy phase with the maintenance therapy phase
• The data are collected at each visit from the 5th cycle of chemotherapy until the end of the 3-month niraparib treatment and evaluated after the follow-up (after 3 and 6 months).
• For each visit, patients complete questionnaires (SF-12, FACT-F, QLQ-C30 & OV28, PRO CTCAE) and carry an "Activity Tracker" throughout the entire observation period

• Assessment of the correlation between QoL (measured by questionnaires) and activity level measured by an activity tracker at different time points

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • University Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2019/06/01
  •   330
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• Female participant must be 18 years or older
• Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent (before 5th chemotherapy cycle)
• Able to complete questionnaires independently
• Histologically diagnosed relapsed OC, fallopian tube cancer, or primary peritoneal cancer
• Patients under chemotherapy with no signs of progression before cycle 5 and planed for two additional chemotherapy cycles
• Patients eligible for Niraparib maintenance therapy according to SmPC being able to take oral medications
• Patients must be willing to wear the activity tracker (bracelet) during the entire observation period
Sub-Study (NIRvertical):
• Only patients with first relapse of ovarian cancer at time of progression (before surgery or chemotherapy)

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Exclusion Criteria

• Known hypersensitivity to the components of the product (Niraparib)
• Pregnancy or breast feeding
• Patients who have completed chemotherapy

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Addresses

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    • Nord-Ostdeutsche Gesellschaft für Gynäkologische -NOGGO e.V. c/o Charité Universitätsmedizin Berlin Campus Virchow-Klinikum Klinik für Gynäkologie
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • IKF Klinische Krebsforschung GmbH am Krankenhaus Nordwest
    • Steinbacher Hohl 2-26
    • 60488  Frankfurt am Main
    • Germany
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    • Nord-Ostdeutsche Gesellschaft für Gynäkologische -NOGGO e.V. c/o Charité Universitätsmedizin Berlin Campus Virchow-Klinikum Klinik für Gynäkologie
    • Ms.  Anne-Sophie  Gimpel 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Nord-Ostdeutsche Gesellschaft für Gynäkologische -NOGGO e.V. c/o Charité Universitätsmedizin Berlin Campus Virchow-Klinikum Klinik für Gynäkologie
    • Ms.  Anne-Sophie  Gimpel 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • TESARO Bio Germany GmbH
    • Leopoldstr. 37A
    • 80802  München
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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