HD11 for Intermediate Stages

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ClinicalTrials.gov Identifier: NCT00264953

Recruitment Status : Completed

First Posted : December 13, 2005

Last Update Posted : August 4, 2011

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by:

University of Cologne

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hodgkin´s Lymphoma	Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: DTIC Drug: Etoposide Drug: Procarbazine Drug: Prednisone Drug: Vincristine Radiation: radiation therapy	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1395 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Study Start Date :	May 1998
Actual Primary Completion Date :	January 2003

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Hodgkin Lymphoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: A 4x ABVD plus 30Gy IF-RT	Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: DTIC Radiation: radiation therapy 20 or 30Gy IF-RT
Experimental: C 4x BEACOPP baseline plus 30Gy IF-RT	Drug: Adriamycin Drug: Bleomycin Drug: Etoposide Drug: Procarbazine Drug: Prednisone Drug: Vincristine Radiation: radiation therapy 20 or 30Gy IF-RT
Experimental: B 4x ABVD plus 20Gy IF-RT	Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: DTIC Radiation: radiation therapy 20 or 30Gy IF-RT
Experimental: D 4x BEACOPP baseline plus 20Gy IF-RT	Drug: Adriamycin Drug: Bleomycin Drug: Etoposide Drug: Procarbazine Drug: Prednisone Drug: Vincristine Radiation: radiation therapy 20 or 30Gy IF-RT

Outcome Measures

Eligibility Criteria

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Ages Eligible for Study:	16 Years to 75 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264953

Sponsors and Collaborators

University of Cologne

Investigators

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Principal Investigator:	Volker Diehl, Prof.	University of Cologne

More Information

Additional Information:

Description od study in German (Website of the Competence Network Malignant Lymphoma) This link exits the ClinicalTrials.gov site

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	German Hodgkin Study Group
ClinicalTrials.gov Identifier:	NCT00264953
Other Study ID Numbers:	HD11
First Posted:	December 13, 2005 Key Record Dates
Last Update Posted:	August 4, 2011
Last Verified:	July 2011

Keywords provided by University of Cologne:


Hodgkin´s lymphoma intermediate stages

Additional relevant MeSH terms:

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Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Prednisone Etoposide Vincristine Doxorubicin Liposomal doxorubicin Bleomycin Vinblastine	Procarbazine Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Tubulin Modulators Antimitotic Agents

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