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HD10 for Early Stages

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00265018
Enrollment
1370
Registered
2005-12-13
Start date
1998-05-31
Completion date
Unknown
Last updated
2011-07-29

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, early stages

Brief summary

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.

Interventions

DRUGAdriamycin
DRUGBleomycin
DRUGVinblastine
DRUGDTIC
RADIATION30 Gy IF-RT
RADIATION20 Gy 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,IIB without any of the following risk factors: 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

Design outcomes

Primary

MeasureTime frame
Progression free survival (PFS)5 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026