Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003455

Trial Description

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Title

HD16 for Early Stages - Treatment Optimization Trial in the First-line Treatment of Early Stage Hodgkin Lymphoma; Treatment Stratification by Means of FDG-PET

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study is designed to test the non-inferiority of the experimental arm compared to the
standard arm in terms of Progression free survival (PFS).

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003455
  •   2014/06/18
  •   2008/08/08
  •   yes
  •   [---]*
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Secondary IDs

  •   NCT00736320  (ClinicalTrials.gov)
  •   HD16  (University of Cologne)
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Health Condition or Problem studied

  •   Hodgkin Lymphoma
  •   C81 -  Hodgkin lymphoma
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Interventions/Observational Groups

  •   Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)
  •   Radiation: 20 Gy IFRT (Involved Field Radiotherapy)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Progression Free Survival; time frame: 5 years

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Secondary Outcome

- overall survival; time frame: 5 years
- acute toxicity; time frame: 5 years
- late toxicity; time frame: 5 years
- CR rate; time frame: 5 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2009/11/30
  •   1100
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

- Hodgkin Lymphoma

- CS I, II without risk factors

- large mediastinal mass (> 1/3 of maximum transverse thorax diameter)

- extranodal involvement

- elevated ESR

- 3 or more involved nodal areas

- Written informed consent

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Exclusion Criteria

- Leucocytes < 3000/µl

- Platelets < 100000/µl

- Hodgkin Lymphoma as composite lymphoma

- Activity index (WHO) > 2

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Addresses

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    • University of Cologne
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    • University of Cologne
    • Andreas Engert, Prof. 
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    •   [---]*
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    • Michael Fuchs 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2014/06/16
* This entry means the parameter is not applicable or has not been set.