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HD11 for Intermediate Stages

This study has been completed.
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00264953
First received: December 12, 2005
Last updated: August 3, 2011
Last verified: July 2011
History of Changes

December 12, 2005
August 3, 2011
May 1998
January 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00264953 on ClinicalTrials.gov Archive Site
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HD11 for Intermediate Stages
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This study is designed to (1) compare the efficacy of the BEACOPP regimen with that of ABVD as a 4-cycle chemotherapy combined with an involved field irradiation and (2) to define the optimum radiation dose comparing of 30 to 20 Gy in the same context.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Hodgkin´s Lymphoma
  • Drug: Adriamycin
  • Drug: Bleomycin
  • Drug: Vinblastine
  • Drug: DTIC
  • Drug: Etoposide
  • Drug: Procarbazine
  • Drug: Prednisone
  • Drug: Vincristine
  • Radiation: radiation therapy
    20 or 30Gy IF-RT
  • Active Comparator: A
    4x ABVD plus 30Gy IF-RT
    Interventions:
    • Drug: Adriamycin
    • Drug: Bleomycin
    • Drug: Vinblastine
    • Drug: DTIC
    • Radiation: radiation therapy
  • Experimental: C
    4x BEACOPP baseline plus 30Gy IF-RT
    Interventions:
    • Drug: Adriamycin
    • Drug: Bleomycin
    • Drug: Etoposide
    • Drug: Procarbazine
    • Drug: Prednisone
    • Drug: Vincristine
    • Radiation: radiation therapy
  • Experimental: B
    4x ABVD plus 20Gy IF-RT
    Interventions:
    • Drug: Adriamycin
    • Drug: Bleomycin
    • Drug: Vinblastine
    • Drug: DTIC
    • Radiation: radiation therapy
  • Experimental: D
    4x BEACOPP baseline plus 20Gy IF-RT
    Interventions:
    • Drug: Adriamycin
    • Drug: Bleomycin
    • Drug: Etoposide
    • Drug: Procarbazine
    • Drug: Prednisone
    • Drug: Vincristine
    • Radiation: radiation therapy
Eich HT, Diehl V, Görgen H, Pabst T, Markova J, Debus J, Ho A, Dörken B, Rank A, Grosu AL, Wiegel T, Karstens JH, Greil R, Willich N, Schmidberger H, Döhner H, Borchmann P, Müller-Hermelink HK, Müller RP, Engert A. Intensified chemotherapy and dose-reduced involved-field radiotherapy in patients with early unfavorable Hodgkin's lymphoma: final analysis of the German Hodgkin Study Group HD11 trial. J Clin Oncol. 2010 Sep 20;28(27):4199-206. Epub 2010 Aug 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1395
Not Provided
January 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hodgkin´s lymphoma (histologically proven)

  • CS (PS) IA, IB, IIA, with one of the risk factors a-d CS (PS) IIB only with risk factor c or d

    1. bulky mediastinal mass (> 1/3 maximum transverse thorax diameter)
    2. extranodal involvement
    3. ESR > 50 (A), > 30 (B-symptoms)
    4. 3 or more lymph node areas involved
  • written informaed consent

Exclusion Criteria:

  • Leukocytes <3000/microl
  • Platelets <100000/microl
  • Hodgkin´s Disease as "composite lymphoma"
  • Activity index (WHO) < grade 2
Both
16 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00264953
HD11
Not Provided
German Hodgkin Study Group
University of Cologne
Not Provided
Principal Investigator: Volker Diehl, Prof. University of Cologne
University of Cologne
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP