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HD12 for Advanced Stages

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00265031
First Posted: December 13, 2005
Last Update Posted: June 25, 2012
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.
Information provided by:
University of Cologne
  Purpose
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 Intervention Phase
Hodgkin´s Lymphoma Drug: Cyclophosphamide Drug: Adriamycin Drug: Etoposide Drug: Procarbazine Drug: Prednisone Drug: Vincristine Drug: Bleomycin Procedure: radiation therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Study Start Date: January 1999
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00265031


Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Volker Diehl, Prof. University of Cologne
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00265031     History of Changes
Other Study ID Numbers: HD12
First Submitted: December 12, 2005
First Posted: December 13, 2005
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:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Prednisone
Etoposide
Vincristine
Doxorubicin
Bleomycin
Procarbazine
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic