Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

HD12 for Advanced Stages

This study has been completed.
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00265031
First received: December 12, 2005
Last updated: June 22, 2012
Last verified: August 2007
  Purpose

This study is designed to test (1) whether the BEACOPP dosage can be reduced to baseline in the last 4 cycles without loss of effectiveness, and (2) whether consolidating irradiation is necessary following effective chemotherapy.


Condition Intervention Phase
Hodgkin´s Lymphoma
Drug: Cyclophosphamide
Drug: Adriamycin
Drug: Etoposide
Drug: Procarbazine
Drug: Prednisone
Drug: Vincristine
Drug: Bleomycin
Procedure: 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:

Study Start Date: January 1999
  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hodgkin´s lymphoma (histologically proven)
  • CS(PS) IIB with one or both of the risk factors:

    1. bulky mediastinal mass (> 1/3 of maximum transverse thorax diameter)
    2. extranodal involvement
  • CS(PS) III, IV
  • 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: NCT00265031

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