HD11 for Intermediate Stages
1 other identifier
interventional
1,395
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
December 12, 2005
CompletedFirst Posted
Study publicly available on registry
December 13, 2005
CompletedAugust 4, 2011
July 1, 2011
4.7 years
December 12, 2005
August 3, 2011
Conditions
Keywords
Study Arms (4)
A
ACTIVE COMPARATOR4x ABVD plus 30Gy IF-RT
C
EXPERIMENTAL4x BEACOPP baseline plus 30Gy IF-RT
B
EXPERIMENTAL4x ABVD plus 20Gy IF-RT
D
EXPERIMENTAL4x BEACOPP baseline plus 20Gy IF-RT
Interventions
Eligibility Criteria
You may qualify if:
- 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)
- or more lymph node areas involved
- written informaed consent
You may not qualify if:
- Leukocytes \<3000/microl
- Platelets \<100000/microl
- Hodgkin´s Disease as "composite lymphoma"
- Activity index (WHO) \< grade 2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Eich HT, Diehl V, Gorgen H, Pabst T, Markova J, Debus J, Ho A, Dorken B, Rank A, Grosu AL, Wiegel T, Karstens JH, Greil R, Willich N, Schmidberger H, Dohner H, Borchmann P, Muller-Hermelink HK, Muller RP, Engert A. Intensified chemotherapy and dose-reduced involved-field radiotherapy in patients with early unfavorable Hodgkin's lymphoma: final analysis of the German Hodgkin Study Group HD11 trial. J Clin Oncol. 2010 Sep 20;28(27):4199-206. doi: 10.1200/JCO.2010.29.8018. Epub 2010 Aug 16.
PMID: 20713848RESULTHay AE, Klimm B, Chen BE, Goergen H, Shepherd LE, Fuchs M, Gospodarowicz MK, Borchmann P, Connors JM, Markova J, Crump M, Lohri A, Winter JN, Dorken B, Pearcey RG, Diehl V, Horning SJ, Eich HT, Engert A, Meyer RM; Conducted by the NCIC Clinical Trials Group (Canada) and German Hodgkin Study Group (GHSG). An individual patient-data comparison of combined modality therapy and ABVD alone for patients with limited-stage Hodgkin lymphoma. Ann Oncol. 2013 Dec;24(12):3065-9. doi: 10.1093/annonc/mdt389. Epub 2013 Oct 11.
PMID: 24121121DERIVEDBoll B, Gorgen H, Fuchs M, Pluetschow A, Eich HT, Bargetzi MJ, Weidmann E, Junghanss C, Greil R, Scherpe A, Schmalz O, Eichenauer DA, von Tresckow B, Rothe A, Diehl V, Engert A, Borchmann P. ABVD in older patients with early-stage Hodgkin lymphoma treated within the German Hodgkin Study Group HD10 and HD11 trials. J Clin Oncol. 2013 Apr 20;31(12):1522-9. doi: 10.1200/JCO.2012.45.4181. Epub 2013 Mar 18.
PMID: 23509310DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Volker Diehl, Prof.
University of Cologne
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 12, 2005
First Posted
December 13, 2005
Study Start
May 1, 1998
Primary Completion
January 1, 2003
Last Updated
August 4, 2011
Record last verified: 2011-07