HD10 for Early Stages

This study has been completed.
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00265018
First received: December 12, 2005
Last updated: July 28, 2011
Last verified: July 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265018

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00265018     History of Changes
Other Study ID Numbers: HD10
Study First Received: December 12, 2005
Last Updated: July 28, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 23, 2014