HD11 for Intermediate Stages

August 3, 2011 updated by: University of Cologne
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1395

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A
4x ABVD plus 30Gy IF-RT
Drug: Bleomycin
Drug: Vinblastine
Drug: Adriamycin
Drug: DTIC
Radiation: radiation therapy
20 or 30Gy IF-RT
EXPERIMENTAL: C
4x BEACOPP baseline plus 30Gy IF-RT
Drug: Prednisone
Drug: Vincristine
Drug: Bleomycin
Drug: Etoposide
Drug: Adriamycin
Drug: Procarbazine
Radiation: radiation therapy
20 or 30Gy IF-RT
EXPERIMENTAL: B
4x ABVD plus 20Gy IF-RT
Drug: Bleomycin
Drug: Vinblastine
Drug: Adriamycin
Drug: DTIC
Radiation: radiation therapy
20 or 30Gy IF-RT
EXPERIMENTAL: D
4x BEACOPP baseline plus 20Gy IF-RT
Drug: Prednisone
Drug: Vincristine
Drug: Bleomycin
Drug: Etoposide
Drug: Adriamycin
Drug: Procarbazine
Radiation: radiation therapy
20 or 30Gy IF-RT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1998

Primary Completion (ACTUAL)

January 1, 2003

Study Registration Dates

First Submitted

December 12, 2005

First Submitted That Met QC Criteria

December 12, 2005

First Posted (ESTIMATE)

December 13, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

August 4, 2011

Last Update Submitted That Met QC Criteria

August 3, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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