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HD10 for Early Stages

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ClinicalTrials.gov Identifier: NCT00265018
Recruitment Status : Completed
First Posted : December 13, 2005
Last Update Posted : July 29, 2011
Sponsor:
Information provided by:
University of Cologne

Study Description
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Brief Summary:
This study is designed to find the optimum radiation dose and number of cycles for an ABVD chemotherapy combined with an involved field irradiation. It is to be tested whether the reduction from 4 to 2 cycles of ABVD and/or the reduction of the radiation dose from 30 to 20 Gy is feasible without a loss of efficacy.

Condition or disease Intervention/treatment Phase
Hodgkin´s Lymphoma Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: DTIC Radiation: 30 Gy IF-RT Radiation: 20 Gy IF-RT Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1370 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 1998
Actual Primary Completion Date : January 2003

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm A Drug: Adriamycin
Drug: Bleomycin
Drug: Vinblastine
Drug: DTIC
Radiation: 30 Gy IF-RT
Experimental: Arm B Drug: Adriamycin
Drug: Bleomycin
Drug: Vinblastine
Drug: DTIC
Radiation: 20 Gy IF-RT
Experimental: Arm C Drug: Adriamycin
Drug: Bleomycin
Drug: Vinblastine
Drug: DTIC
Radiation: 30 Gy IF-RT
Experimental: Arm D Drug: Adriamycin
Drug: Bleomycin
Drug: Vinblastine
Drug: DTIC
Radiation: 20 Gy IF-RT


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 5 years ]

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

Inclusion Criteria:

  • Hodgkin´s lymphoma (histologically proven)

  • CS (PS) IA, IB, IIA,IIB without any of the following risk factors:

    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
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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): NCT00265018


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

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00265018    
Other Study ID Numbers: HD10
First Posted: December 13, 2005    Key Record Dates
Last Update Posted: July 29, 2011
Last Verified: July 2011
Keywords provided by University of Cologne:
Hodgkin´s lymphoma
early stages
Additional relevant MeSH terms:
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Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Doxorubicin
Liposomal doxorubicin
Bleomycin
 Vinblastine
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators