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HD10 for Early Stages

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00265018
First Posted: December 13, 2005
Last Update Posted: July 29, 2011
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 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 Intervention 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 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:

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

Enrollment: 1370
Study Start Date: May 1998
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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,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
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): NCT00265018


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):
ClinicalTrials.gov Identifier: NCT00265018     History of Changes
Other Study ID Numbers: HD10
First Submitted: December 12, 2005
First Posted: December 13, 2005
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:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
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