HD12 for Advanced Stages

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ClinicalTrials.gov Identifier: NCT00265031

Recruitment Status : Completed

First Posted : December 13, 2005

Last Update Posted : June 25, 2012

Sponsor:

Information provided by:

University of Cologne

Study Description

Brief Summary:

This study is designed to test (1) whether the BEACOPP dosage can be reduced to baseline in the last 4 cycles without loss of effectiveness, and (2) whether consolidating irradiation is necessary following effective chemotherapy.

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Study Start Date :	January 1999

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

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	16 Years to 65 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hodgkin´s lymphoma (histologically proven)
CS(PS) IIB with one or both of the risk factors:
1. bulky mediastinal mass (> 1/3 of maximum transverse thorax diameter)
2. extranodal involvement
CS(PS) III, IV
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): NCT00265031

Sponsors and Collaborators

University of Cologne

Investigators

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Principal Investigator:	Volker Diehl, Prof.	University of Cologne

More Information

Additional Information:

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

Publications of Results:

Borchmann P, Haverkamp H, Diehl V, Cerny T, Markova J, Ho AD, Eich HT, Mueller-Hermelink HK, Kanz L, Greil R, Rank A, Paulus U, Smardova L, Huber C, Dörken B, Nerl C, Krause SW, Mueller RP, Fuchs M, Engert A. Eight cycles of escalated-dose BEACOPP compared with four cycles of escalated-dose BEACOPP followed by four cycles of baseline-dose BEACOPP with or without radiotherapy in patients with advanced-stage hodgkin's lymphoma: final analysis of the HD12 trial of the German Hodgkin Study Group. J Clin Oncol. 2011 Nov 10;29(32):4234-42. doi: 10.1200/JCO.2010.33.9549. Epub 2011 Oct 11.

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

von Tresckow B, Kreissl S, Goergen H, Bröckelmann PJ, Pabst T, Fridrik M, Rummel M, Jung W, Thiemer J, Sasse S, Bürkle C, Baues C, Diehl V, Engert A, Borchmann P; German Hodgkin Study Group. Intensive treatment strategies in advanced-stage Hodgkin's lymphoma (HD9 and HD12): analysis of long-term survival in two randomised trials. Lancet Haematol. 2018 Oct;5(10):e462-e473. doi: 10.1016/S2352-3026(18)30140-6.

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ClinicalTrials.gov Identifier:	NCT00265031
Other Study ID Numbers:	HD12
First Posted:	December 13, 2005 Key Record Dates
Last Update Posted:	June 25, 2012
Last Verified:	August 2007

Keywords provided by University of Cologne:


Hodgkin´s Lymphoma advanced 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 Cyclophosphamide Etoposide Vincristine Doxorubicin Liposomal doxorubicin Bleomycin	Procarbazine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal

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