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HD12 for Advanced Stages

Primary Purpose

Hodgkin´s Lymphoma

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

About this trial

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

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hodgkin´s lymphoma (histologically proven) CS(PS) IIB with one or both of the risk factors: bulky mediastinal mass (> 1/3 of maximum transverse thorax diameter) extranodal involvement CS(PS) III, IV written informaed consent Exclusion Criteria: Leukocytes <3000/microl Platelets <100000/microl Hodgkin´s Disease as "composite lymphoma" Activity index (WHO) < grade 2

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 12, 2005
    Last Updated
    June 22, 2012
    Sponsor
    University of Cologne
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00265031
    Brief Title
    HD12 for Advanced Stages
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1999 (undefined)
    Primary Completion Date
    undefined (undefined)
    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 test (1) whether the BEACOPP dosage can be reduced to baseline in the last 4 cycles without loss of effectiveness, and (2) whether consolidating irradiation is necessary following effective chemotherapy.

    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, advanced stages

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Cyclophosphamide
    Intervention Type
    Drug
    Intervention Name(s)
    Adriamycin
    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
    Drug
    Intervention Name(s)
    Bleomycin
    Intervention Type
    Procedure
    Intervention Name(s)
    radiation therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hodgkin´s lymphoma (histologically proven) CS(PS) IIB with one or both of the risk factors: bulky mediastinal mass (> 1/3 of maximum transverse thorax diameter) extranodal involvement CS(PS) III, IV 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
    21990399
    Citation
    Borchmann P, Haverkamp H, Diehl V, Cerny T, Markova J, Ho AD, Eich HT, Mueller-Hermelink HK, Kanz L, Greil R, Rank A, Paulus U, Smardova L, Huber C, Dorken B, Nerl C, Krause SW, Mueller RP, Fuchs M, Engert A. Eight cycles of escalated-dose BEACOPP compared with four cycles of escalated-dose BEACOPP followed by four cycles of baseline-dose BEACOPP with or without radiotherapy in patients with advanced-stage hodgkin's lymphoma: final analysis of the HD12 trial of the German Hodgkin Study Group. J Clin Oncol. 2011 Nov 10;29(32):4234-42. doi: 10.1200/JCO.2010.33.9549. Epub 2011 Oct 11.
    Results Reference
    result
    PubMed Identifier
    30290903
    Citation
    von Tresckow B, Kreissl S, Goergen H, Brockelmann PJ, Pabst T, Fridrik M, Rummel M, Jung W, Thiemer J, Sasse S, Burkle C, Baues C, Diehl V, Engert A, Borchmann P; German Hodgkin Study Group. Intensive treatment strategies in advanced-stage Hodgkin's lymphoma (HD9 and HD12): analysis of long-term survival in two randomised trials. Lancet Haematol. 2018 Oct;5(10):e462-e473. doi: 10.1016/S2352-3026(18)30140-6.
    Results Reference
    derived
    Links:
    URL
    http://www.lymphome.de/Gruppen/GHSG/
    Description
    Description of study i German (Website of the Competence Network Malignant Lymphoma)

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    HD12 for Advanced Stages

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