HD11 for Intermediate Stages - Full Text View

Purpose

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	Intervention	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 Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Hodgkin Disease Lymphoma Steroids

Drug Information available for: Prednisone Vinblastine sulfate Procarbazine hydrochloride Procarbazine Vinblastine Vincristine sulfate Bleomycin sulfate Bleomycin Doxorubicin Doxorubicin hydrochloride Etoposide Etoposide phosphate

U.S. FDA Resources

Further study details as provided by University of Cologne:

Enrollment:	1395
Study Start Date:	May 1998
Primary Completion Date:	January 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	16 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264953

Sponsors and Collaborators

University of Cologne

Investigators

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:

Eich HT, Diehl V, Görgen H, Pabst T, Markova J, Debus J, Ho A, Dörken B, Rank A, Grosu AL, Wiegel T, Karstens JH, Greil R, Willich N, Schmidberger H, Döhner H, Borchmann P, Müller-Hermelink HK, Müller 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. Epub 2010 Aug 16.

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

Böll B, Görgen 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.

Responsible Party:	German Hodgkin Study Group
ClinicalTrials.gov Identifier:	NCT00264953 History of Changes
Other Study ID Numbers:	HD11
Study First Received:	December 12, 2005
Last Updated:	August 3, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:

Hodgkin´s lymphoma
intermediate stages

Additional relevant MeSH terms:

Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bleomycin
Doxorubicin
Etoposide
Prednisone
Procarbazine
Vinblastine
Vincristine

Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Anti-Inflammatory Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013