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HD11 for Intermediate Stages

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00264953
Enrollment
1395
Registered
2005-12-13
Start date
1998-05-31
Completion date
Unknown
Last updated
2011-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin´s Lymphoma

Keywords

Hodgkin´s lymphoma, intermediate stages

Brief summary

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.

Interventions

DRUGAdriamycin
DRUGBleomycin
DRUGVinblastine
DRUGDTIC
DRUGEtoposide
DRUGProcarbazine
DRUGPrednisone
DRUGVincristine
RADIATIONradiation therapy

20 or 30Gy IF-RT

Sponsors

University of Cologne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026