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OpenTrials
Completed

NCT Number: NCT00264953

HD11 for Intermediate Stages

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.

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Key information

Conditions

Hodgkin´s Lymphoma

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • bulky mediastinal mass (> 1/3 maximum transverse thorax diameter)
  • extranodal involvement
  • ESR > 50 (A), > 30 (B-symptoms)
  • 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

Treatment and study plan

Adriamycin

Drug

Bleomycin

Drug

Vinblastine

Drug

DTIC

Drug

etoposide

Drug

Procarbazine

Drug

Prednisone

Drug

Vincristine

Drug

radiation therapy

Radiation

20 or 30Gy IF-RT

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Important dates

Study start
1998
Primary completion
2003
First posted
Dec 13, 2005
Registry last updated
Aug 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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