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OpenTrials
Completed

NCT Number: NCT00265018

HD10 for Early Stages

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.

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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,IIB without any of the following risk factors:
  • 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

30 Gy IF-RT

Radiation

20 Gy IF-RT

Radiation

Primary outcomes

  1. Progression free survival (PFS)

    Time frame: 5 years

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
Jul 29, 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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