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HD11 for Intermediate Stages

Primary Purpose

Hodgkin´s Lymphoma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Adriamycin
Bleomycin
Vinblastine
DTIC
Etoposide
Procarbazine
Prednisone
Vincristine
radiation therapy
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin´s Lymphoma focused on measuring Hodgkin´s lymphoma, intermediate stages

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 bulky mediastinal mass (> 1/3 maximum transverse thorax diameter) extranodal involvement ESR > 50 (A), > 30 (B-symptoms) 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    A

    C

    B

    D

    Arm Description

    4x ABVD plus 30Gy IF-RT

    4x BEACOPP baseline plus 30Gy IF-RT

    4x ABVD plus 20Gy IF-RT

    4x BEACOPP baseline plus 20Gy IF-RT

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 12, 2005
    Last Updated
    August 3, 2011
    Sponsor
    University of Cologne
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00264953
    Brief Title
    HD11 for Intermediate Stages
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1998 (undefined)
    Primary Completion Date
    January 2003 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Cologne

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hodgkin´s Lymphoma
    Keywords
    Hodgkin´s lymphoma, intermediate stages

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1395 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Active Comparator
    Arm Description
    4x ABVD plus 30Gy IF-RT
    Arm Title
    C
    Arm Type
    Experimental
    Arm Description
    4x BEACOPP baseline plus 30Gy IF-RT
    Arm Title
    B
    Arm Type
    Experimental
    Arm Description
    4x ABVD plus 20Gy IF-RT
    Arm Title
    D
    Arm Type
    Experimental
    Arm Description
    4x BEACOPP baseline plus 20Gy IF-RT
    Intervention Type
    Drug
    Intervention Name(s)
    Adriamycin
    Intervention Type
    Drug
    Intervention Name(s)
    Bleomycin
    Intervention Type
    Drug
    Intervention Name(s)
    Vinblastine
    Intervention Type
    Drug
    Intervention Name(s)
    DTIC
    Intervention Type
    Drug
    Intervention Name(s)
    Etoposide
    Intervention Type
    Drug
    Intervention Name(s)
    Procarbazine
    Intervention Type
    Drug
    Intervention Name(s)
    Prednisone
    Intervention Type
    Drug
    Intervention Name(s)
    Vincristine
    Intervention Type
    Radiation
    Intervention Name(s)
    radiation therapy
    Intervention Description
    20 or 30Gy IF-RT

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 bulky mediastinal mass (> 1/3 maximum transverse thorax diameter) extranodal involvement ESR > 50 (A), > 30 (B-symptoms) 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Volker Diehl, Prof.
    Organizational Affiliation
    University of Cologne
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20713848
    Citation
    Eich HT, Diehl V, Gorgen H, Pabst T, Markova J, Debus J, Ho A, Dorken B, Rank A, Grosu AL, Wiegel T, Karstens JH, Greil R, Willich N, Schmidberger H, Dohner H, Borchmann P, Muller-Hermelink HK, Muller 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. doi: 10.1200/JCO.2010.29.8018. Epub 2010 Aug 16.
    Results Reference
    result
    PubMed Identifier
    24121121
    Citation
    Hay AE, Klimm B, Chen BE, Goergen H, Shepherd LE, Fuchs M, Gospodarowicz MK, Borchmann P, Connors JM, Markova J, Crump M, Lohri A, Winter JN, Dorken B, Pearcey RG, Diehl V, Horning SJ, Eich HT, Engert A, Meyer RM; Conducted by the NCIC Clinical Trials Group (Canada) and German Hodgkin Study Group (GHSG). An individual patient-data comparison of combined modality therapy and ABVD alone for patients with limited-stage Hodgkin lymphoma. Ann Oncol. 2013 Dec;24(12):3065-9. doi: 10.1093/annonc/mdt389. Epub 2013 Oct 11.
    Results Reference
    derived
    PubMed Identifier
    23509310
    Citation
    Boll B, Gorgen H, Fuchs M, Pluetschow A, Eich HT, Bargetzi MJ, Weidmann E, Junghanss C, Greil R, Scherpe A, Schmalz O, Eichenauer DA, von Tresckow B, Rothe A, Diehl V, Engert A, Borchmann P. ABVD in older patients with early-stage Hodgkin lymphoma treated within the German Hodgkin Study Group HD10 and HD11 trials. J Clin Oncol. 2013 Apr 20;31(12):1522-9. doi: 10.1200/JCO.2012.45.4181. Epub 2013 Mar 18.
    Results Reference
    derived
    Links:
    URL
    http://www.lymphome.de/Gruppen/GHSG/
    Description
    Description od study in German (Website of the Competence Network Malignant Lymphoma)

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    HD11 for Intermediate Stages

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