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HD12 for Advanced Stages

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00265031
Recruitment Status : Completed
First Posted : December 13, 2005
Last Update Posted : June 25, 2012
Information provided by:
University of Cologne

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.

Condition or disease Intervention/treatment Phase
Hodgkin´s Lymphoma Drug: Cyclophosphamide Drug: Adriamycin Drug: Etoposide Drug: Procarbazine Drug: Prednisone Drug: Vincristine Drug: Bleomycin Procedure: radiation therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 1999

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hodgkin´s lymphoma (histologically proven)
  • CS(PS) IIB with one or both of the risk factors:

    1. bulky mediastinal mass (> 1/3 of maximum transverse thorax diameter)
    2. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00265031

Sponsors and Collaborators
University of Cologne
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Principal Investigator: Volker Diehl, Prof. University of Cologne
Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00265031    
Other Study ID Numbers: HD12
First Posted: December 13, 2005    Key Record Dates
Last Update Posted: June 25, 2012
Last Verified: August 2007
Keywords provided by University of Cologne:
Hodgkin´s Lymphoma
advanced stages
Additional relevant MeSH terms:
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Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal