HD11 for Intermediate Stages

This study has been completed.
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00264953
First received: December 12, 2005
Last updated: August 3, 2011
Last verified: July 2011
  Purpose

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 Intervention 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 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:

Enrollment: 1395
Study Start Date: May 1998
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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, 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
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: NCT00264953

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):
Responsible Party: German Hodgkin Study Group
ClinicalTrials.gov Identifier: NCT00264953     History of Changes
Other Study ID Numbers: HD11
Study First Received: December 12, 2005
Last Updated: August 3, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Procarbazine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014