Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1395 participants
INTERVENTIONAL
1998-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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A
4x ABVD plus 30Gy IF-RT
Adriamycin
Bleomycin
Vinblastine
DTIC
radiation therapy
20 or 30Gy IF-RT
C
4x BEACOPP baseline plus 30Gy IF-RT
Adriamycin
Bleomycin
Etoposide
Procarbazine
Prednisone
Vincristine
radiation therapy
20 or 30Gy IF-RT
B
4x ABVD plus 20Gy IF-RT
Adriamycin
Bleomycin
Vinblastine
DTIC
radiation therapy
20 or 30Gy IF-RT
D
4x BEACOPP baseline plus 20Gy IF-RT
Adriamycin
Bleomycin
Etoposide
Procarbazine
Prednisone
Vincristine
radiation therapy
20 or 30Gy IF-RT
Interventions
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Adriamycin
Bleomycin
Vinblastine
DTIC
Etoposide
Procarbazine
Prednisone
Vincristine
radiation therapy
20 or 30Gy IF-RT
Eligibility Criteria
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Inclusion Criteria
* 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
* Platelets \<100000/microl
* Hodgkin´s Disease as "composite lymphoma"
* Activity index (WHO) \< grade 2
16 Years
75 Years
ALL
No
Sponsors
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University of Cologne
OTHER
Responsible Party
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German Hodgkin Study Group
Principal Investigators
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Volker Diehl, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Cologne
References
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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.
Hay 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.
Boll 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.
Related Links
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Description od study in German (Website of the Competence Network Malignant Lymphoma)
Other Identifiers
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HD11
Identifier Type: -
Identifier Source: org_study_id
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