Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

HD10 for Early 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.
 
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for investigator information
Principal Investigator: Volker Diehl, Prof. University of Cologne
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Description of study in Gereman (Website of the Competence Network Malignant Lymphoma  This link exits the ClinicalTrials.gov site

Publications of Results:

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

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00265018     History of Changes
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:
Layout table for 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