Trial document




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  DRKS00004384

Trial Description

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Title

Register Study Standard Proton Therapy WPE - Adults -

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Trial Acronym

ProReg

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URL of the Trial

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Brief Summary in Lay Language

Background of the study is the increasing clinical use of proton therapy. Aim is to assure that analyzable data regarding course of disease and side effects are generated during proton therapy. The basis for later evaluation concerning options and benefits of proton therapy can be established through documentation of the collected data in this Register Study. Treatment data are documented from each patient receiving proton therapy.

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Brief Summary in Scientific Language

By increasing clinical use of proton therapy, the Register Study is to assure that analyzable data regarding toxicity, tumor control, and outcome are generated within the scope of patient treatment. The basis for later evaluation concerning options and benefits of proton therapy can be established through documentation of the collected data in this Register Study. Based on the obtained data, future clinical studies (phase II-IV) are to be designed regarding dose escalation, hypofractionation, and randomized comparisons, e.g. with modern technology of proton therapy (e.g. IMRT, tomotherapy, and stereotaxis).

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Organizational Data

  •   DRKS00004384
  •   2012/09/28
  •   [---]*
  •   yes
  •   Approved
  •   12-5143-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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Health Condition or Problem studied

  •   Register Study for adult patients receiving proton therapy.
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Interventions/Observational Groups

  •   Register Study: Data collection from patients receiving proton therapy
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Characteristics

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

Data documentation regarding toxicity, tumor control, and outcome during proton therapy as basis for later evaluation concerning options and benefits of proton therapy.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2013/07/01
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  •   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

• Indication for radiotherapy was given.
• Proton therapy is conducted alternatively to conventional radiotherapy. An accountable indication according to § 80 StrlSchV has to be proposed for each patient by a specialized physician including authoritative documentation during proton therapy within the scope of patient treatment. The designated use of proton therapy is in the realm of medical treatment,
- as far as it is clinically established (e.g. according to guidelines) or
- as far as the indication and treatment scheme (fractionation, total dosis) is equivalent to the established standard of conventional photon therapy.
• Patient does not participate in clinical studies concerning proton therapy.
• No pregnancy verified. If necessary, willingness to use contraception during treatment is given.
• Patient has given informed consent for participation, data documentation, and analysis in the Register Study.

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Exclusion Criteria

[---]*

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Addresses

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    • Westdeutsches Protonentherapiezentrum Essen, Klinik für Partikeltherapie, Universitätsklinikum Essen
    • Ms.  Prof. Dr. med.  Beate  Timmermann 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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    • Westdeutsches Protonentherapiezentrum Essen, Klinik für Partikeltherapie, Universitätsklinikum Essen
    • Mr.  Dr. med.  Dirk  Geismar 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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    • Westdeutsches Protonentherapiezentrum Essen
    • Ms.  Dr.  Stefanie  Schulze Schleithoff 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Westdeutsches Protonentherapiezentrum gGmbH
    • Hufelandstr. 55
    • 45147  Essen
    • 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.