Trial document





This trial has been registered retrospectively.
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  DRKS00011344

Trial Description

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Title

Identifikation of parameters for the development of a Score to predict the non-compliance of patients with recurrent ovarian cancer undergoing a routine therapy with Ovastat(R).
A non-interventional observation trial (NIS)

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Trial Acronym

SCORE trial

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URL of the Trial

http://none

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Brief Summary in Lay Language

Patients suffering from ovarian cancer often interrupt their chemotherapy after only one or two cycles of therapy. In this cases it is unlikely that patients will benefit from the therapy. The aim of this trial is to to develop a score for the prediction of an early therapy discontinuation based on data from questionaires and clinical examinations. This data will be collected before the therapy starts. Once developed, the score can support physicians and patients to decide for or against another line of chemotherapy.

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Brief Summary in Scientific Language

Based on routine clinical examintions ( anamnesis, general condition, laboratory parameters ) and supported by different questionaires concerning previous therapy, expectation on therapy, symptoms of disease (MOST questionaire) and stance on complementary medicine (AKKOM questionair) data from 500 patiens with recurrent ovarian cancer are collected in a non interventional trial.
A treatment with treosulfan (Ovastat(R)) was planned before entering the trial for all patients included. The aim of the trial is to explore the correlations between the collected data and an early discontinuation of therapy and to develop a score based on this correlations. The decision for or against a treosulfan therapy can be supported by the Score so that in case of a high probability of early therapy discontinuation the stress for the patient by another chemotherapy line can be avoided.

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Organizational Data

  •   DRKS00011344
  •   2016/11/21
  •   [---]*
  •   yes
  •   Approved
  •   EA2/005/16, 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

  •   Patients suffering from reccurend ovarian cancer are treated with treosulfan in a non-interventional trial. As treosulfan is approved and can be administered in an intravenous and an oral formulation as well, treosulfan can be used in this trial in both formulations according to patients and physicians preference.
    The dosage is: i.v. treosulfan: 7.000 mg/m2,q3w oder q4w (both time intervalls are according to approval) - alternative : treosulfan oral, 400-600mg/m2 per day for 28 days, q56d
    - in a recent trial, currently in print, Sehouli et.al. could prove equal efficacy for oral and intravenous treosulfan. [A phase III, open label, randomized multicenter controlled trial of oral versus intravenous Treosulfan in heavily pretreated recurrent ovarian cancer: A study of the North-Eastern German Society of Gynecological Oncology (NOGGO); Journal of Cancer Research and Clinical Oncology in press]
    before starting the treatment, Patients answer questionaries concerning cancer realted questtions (MOST questionary), therapyexpierience and - expectation and attitude towards complementary medicine (AKKOM questionary).
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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

Identifikation of parameters for the development of a Score to predict the non-compliance of patients with recurrent ovarian cancer undergoing a routine therapy with treosulfan (Ovastat(R)).

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Secondary Outcome

evalution of preference for a i.v. or oral therapy and reasons for the decision
- dose intensity and duration of treatment
- reasons for therapy discontinuation and dose modification
- tolerability
- concurrent medication
- influence of comarbidity and age on therapy efficacy and and intensity
- determination of objective response (PR+CR) and clinical Benifit (CR+PR+SD)
- median progressiondree Survival (PFS)
- PFS rate after one year
- Time to treatment failure (TTF)
- one Year survival rate
- Subgroup analyses: age <65 and age>65
- previous and subsequent therapies
- relation beteween Therapy compliance and efficacy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2016/08/15
  •   500
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

- patients with recurrent ovarian cancer who have decided to undergo a chemotherapy with treosulfan
- patients aged 18 years or older
- patients who are able to answer questionaires in german language
- willingness to answer questionaires
- before entering the trial informed consent and data privacy statement must be signed by the patient

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Exclusion Criteria

contemporaneous partizipation in a different clinical trial during the time of treatment or within the last 30 days.
- hypersensitivity to treosulfan
- patients with missing or reduced legal competence
- patients in an instituion due to a legal or governmental order
- pregnant and breast-feeding women
- no anamnesis form (contains only data collected in routine anamnesis)

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Addresses

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    • medac Gesellschaft für klinische Spezialpräparate mbH
    • Theaterstraße 6
    • 22880  Wedel
    • Germany
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    • NOGGO e. V.Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologiec/o Charité UniversitätsmedizinCampus Virchow-KlinikumKlinik für Gynäkologie
    • Augustenburger Platz 1
    • D-13353  Berlin
    • Germany
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    • medac Gesellschaft für klinische Spezialpräparate mbH
    • Dr.  Tim  Krüger 
    • Theaterstraße 6
    • 22880  Wedel
    • Germany
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    • medac Gesellschaft für klinische Spezialpräparate mbH
    • Mr.  Dr.  Tim  Krüger 
    • Theaterstraße 6
    • 22880  Wedel
    • Germany
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Sources of Monetary or Material Support

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    • medac Gesellschaft für klinische Spezialpräparate mbH
    • Theaterstraße 6
    • 22880  Wedel
    • 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.