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HD11 for Intermediate Stages

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ClinicalTrials.gov Identifier: NCT00264953
Recruitment Status : Completed
First Posted : December 13, 2005
Last Update Posted : August 4, 2011
Sponsor:
Information provided by:

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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1395 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 1998
Primary Completion Date : January 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: A
4x ABVD plus 30Gy IF-RT
Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: DTIC Radiation: radiation therapy
20 or 30Gy IF-RT
Experimental: C
4x BEACOPP baseline plus 30Gy IF-RT
Drug: Adriamycin Drug: Bleomycin Drug: Etoposide Drug: Procarbazine Drug: Prednisone Drug: Vincristine Radiation: radiation therapy
20 or 30Gy IF-RT
Experimental: B
4x ABVD plus 20Gy IF-RT
Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: DTIC Radiation: radiation therapy
20 or 30Gy IF-RT
Experimental: D
4x BEACOPP baseline plus 20Gy IF-RT
Drug: Adriamycin Drug: Bleomycin Drug: Etoposide Drug: Procarbazine Drug: Prednisone Drug: Vincristine Radiation: radiation therapy
20 or 30Gy IF-RT


Outcome Measures

Eligibility Criteria

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

    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
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): NCT00264953


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

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: German Hodgkin Study Group
ClinicalTrials.gov Identifier: NCT00264953     History of Changes
Other Study ID Numbers: HD11
First Posted: December 13, 2005    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: July 2011

Keywords provided by University of Cologne:
Hodgkin´s lymphoma
intermediate stages

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Etoposide
Vincristine
Doxorubicin
Bleomycin
Vinblastine
Procarbazine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators