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Last Modified: 2/24/2009     First Published: 11/1/2002  
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Phase III Randomized Study of Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Procarbazine, and Prednisone (BEACOPP) Versus Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) in Patients With Stage III or IV Hodgkin's Lymphoma

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive16 to 60OtherEORTC-20012
GELA-EORTC-20012, BNLI-EORTC-20012, GELCAB-EORTC-20012, NORDICLG-EORTC-20012, CAN-NCIC-EORTC-20012, ALLG-HD04, hd8, NCT00049595

Objectives

  1. Compare event-free survival of patients with stage III or IV Hodgkin's lymphoma treated with bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone vs doxorubicin, bleomycin, vinblastine, and dacarbazine.
  2. Compare complete response, disease-free survival, and overall survival of patients treated with these regimens.
  3. Compare quality of life of patients treated with these regimens.
  4. Compare occurrence of second malignancies in patients treated with these regimens.

Entry Criteria

Disease Characteristics:

  • Histologically confirmed Hodgkin's lymphoma
    • No lymphocyte predominant, nodular type (nodular paragranuloma)
    • Clinical stage III or IV disease

  • At least 1 bidimensionally measurable target lesion or extranodal lesion

  • International Prognostic Score of at least 3

Prior/Concurrent Therapy:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • No prior therapy for Hodgkin's lymphoma

Patient Characteristics:

Age

  • 16 to 60

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC greater than 2,000/mm3
  • Platelet count greater than 100,000/mm3

Hepatic

  • No prior uncontrolled hepatitis B viral infection
  • Bilirubin no greater than 2.5 times normal (unless due to Hodgkin's lymphoma)

Renal

  • Creatinine no greater than 2.0 mg/dL (unless due to Hodgkin's lymphoma)

Cardiovascular

  • No severe cardiac disease that would limit normal life expectancy or preclude study
  • LVEF at least 50%

Pulmonary

  • No severe pulmonary disease that would limit normal life expectancy or preclude study
  • Respiratory function at least 30%

Other

  • HIV negative
  • HTLV1 negative
  • No severe active infection
  • No severe neurological or metabolic disease that would limit normal life expectancy or preclude study
  • No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • No psychological, familial, sociological, or geographical condition that would preclude study
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

Expected Enrollment

550

A total of 550 patients (225 per treatment arm) will be accrued for this study within 5.5 years.

Outcomes

Primary Outcome(s)

Event-free survival

Secondary Outcome(s)

Complete response as assessed by Cheson criteria adapted to Hodgkin's lymphoma
Disease-free survival in patients with complete response
Overall survival
Quality of life as assessed by European Organization for Research of the Treatment of Cancer (EORTC) Quality of Life Questionnaire (QoLQ) C30 version 3.0
Occurrence of secondary malignancies

Outline

This is a randomized, multicenter study. Patients are stratified according to International Prognostic Score (3 vs 4 or more) and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (BEACOPP): Patients receive doxorubicin IV over 5 minutes and cyclophosphamide IV on day 1; etoposide IV over 30 minutes on days 1-3; oral procarbazine on days 1-7; oral prednisone on days 1-14; and vincristine IV and bleomycin IV or intramuscularly (IM) on day 8. Patients may receive dexamethasone in place of prednisone. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 9 and continuing until blood counts recover or pegfilgrastim SC on day 9 only. Treatment repeats every 22 days for 8 courses (4 courses escalated dose followed by 4 courses baseline dose) in the absence of disease progression or unacceptable toxicity.

  • Arm II (ABVD): Patients receive doxorubicin IV over 5 minutes, bleomycin IV or IM, vinblastine IV, and dacarbazine IV over 5-10 minutes on days 1 and 15. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at the end of therapy, and then annually for 10 years.

Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Patrice Carde, MD, Study coordinator
Ph: 33-1-4211-4321

Lymphoma Trials Office

David C. Linch, Protocol chair
Ph: 44-171-380-9724

Groupe d'Etudes de Lymphomes de L'Adulte

Marine Divine, MD, Protocol chair
Ph: 33-1-49-814-174

Grup per l'Estudi dels Limfomes de Catalunya i Balears

Anna Sureda, Protocol chair
Ph: 34-93-291-9396

NCIC-Clinical Trials Group

Ralph Meyer, MD, FRCPC, Protocol chair
Ph: 905-387-9495
Email: rmeyer@ctg.queens.ca

Australasian Leukemia and Lymphoma Group

David Ma, MD, Study coordinator
Ph: 61-283-822-378
Devinder Gill, MD, Study coordinator
Ph: 61-73-240-2623
Email: devinder_gill@health.qld.gov.au

Nordic Lymphoma Group

Bengt Glimelius, MD, Protocol chair
Ph: 46-18-611-5513

Trial Sites

Australia
Australian Capital Territory
  Woden
 Canberra Hospital
 Contact Person
Ph: 61-2-6244-2612
New South Wales
  Kingswood
 Nepean Cancer Care Centre at Nepean Hospital
 Contact Person
Ph: 61-2-4734-3500
  Westmead
 Westmead Institute for Cancer Research at Westmead Hospital
 Contact Person
Ph: 61-2-9845-9000
Queensland
  Brisbane
 Princess Alexandra Hospital
 Contact Person
Ph: 61-7-3240-2111
Victoria
  East Melbourne
 Peter MacCallum Cancer Centre
 Contact Person
Ph: 613-9656-1042
 Max Wolf, MD
Ph: 61-3-9656-1087
 Email: max.wolf@petermac.org
  Fitzroy
 St. Vincent's Hospital - Melbourne
 Contact Person
Ph: 61-3-288-2211
Western Australia
  Perth
 Royal Perth Hospital
 Contact Person
Ph: 61-8-9224-2244
Belgium
  Antwerp
 Ziekenhuis Netwerk Antwerpen Middelheim
 Contact Person
Ph: 32-3-280-3111
  Brugge
 AZ Sint-Jan
 Contact Person
Ph: 32-50-45-2111
  Brussels
 Centre Hospitalier Universitaire Brugmann
 Contact Person
Ph: 32-2-477-29-03
 Cliniques Universitaires Saint-Luc
 Contact Person
Ph: 32-2-764-1111
 Hopital Universitaire Erasme
 Contact Person
Ph: 32-2-555-3111
 Institut Jules Bordet
 Contact Person
Ph: 32-2-541-3111
  Charleroi
 Centre Hospitalier Notre Dame - Reine Fabiola
 Contact Person
Ph: 32-71-281-666
  Edegem
 Universitair Ziekenhuis Antwerpen
 Contact Person
Ph: 32-3-821-3000
  Ghent
 Algemeen Ziekenhuis Sint Lucas
 Contact Person
Ph: 32-9-224-6111
  Haine Saint Paul
 Hopital de Jolimont
 Contact Person
Ph: 32-6-423-4180
  Leuven
 U.Z. Gasthuisberg
 Contact Person
Ph: 32-16-33-2211
  Liege
 Centre Hospitalier Regional de la Citadelle
 Contact Person
Ph: 32-4-225-6111
  Mont-Godinne Yvoir
 Clinique Universitaire De Mont-Godinne
 Contact Person
Ph: 32-81-422-111
  Roeselare
 H. Hartziekenhuis - Roeselaere
 Contact Person
Ph: 32-51-237-111
Canada
Alberta
  Calgary
 Tom Baker Cancer Centre - Calgary
 Contact Person
Ph: 403-944-1701
 Douglas A. Stewart
Ph: 403-521-3347
  Edmonton
 Cross Cancer Institute at University of Alberta
 Contact Person
Ph: 780-432-8771
 Neil Sun Chua
Ph: 780-432-8340
Manitoba
  Winnipeg
 CancerCare Manitoba
 Contact Person
Ph: 204-787-2241
 Matthew D. Seftel
Ph: 204-787-1250
 Centre Hospitalier De Dunkerque - CHD
 Contact Person
Ph: 33-3-2828-5900
New Brunswick
  Moncton
 Moncton Hospital
 Contact Person
Ph: 506-857-5111
 Sheldon Rubin
Ph: 506-857-2881
Newfoundland and Labrador
  St. Johns
 Doctor H. Bliss Murphy Cancer Centre
 Contact Person
Ph: 709-777-6480
  St. John's
 Doctor H. Bliss Murphy Cancer Centre
 Grenfell Adams
Ph: 709-777-6545
Nova Scotia
  Halifax
 Nova Scotia Cancer Centre
 Contact Person
Ph: 902-473-6000
 Wanda S. Hasegawa
Ph: 902-473-7005
Ontario
  Kingston
 Cancer Centre of Southeastern Ontario at Kingston General Hospital
 Contact Person
Ph: 613-544-2630
 Tara Baetz
Ph: 613-544-2630
  London
 London Regional Cancer Program at London Health Sciences Centre
 Contact Person
Ph: 519-685-8600
 Kang Howson-Jan
Ph: 519-685-5194
  Ottawa
 Ottawa Hospital Regional Cancer Centre - General Campus
 Isabelle Bence-Bruckler
Ph: 613-737-8152
  Sudbury
 Northeastern Ontario Regional Cancer Centre
 Contact Person
Ph: 705-522-6237
  Toronto
 Edmond Odette Cancer Centre at Sunnybrook
 Contact Person
Ph: 416-480-5000
 Rena Buckstein
Ph: 416-480-5000
 Princess Margaret Hospital
 Contact Person
Ph: 416-946-2811
 Michael Crump
Ph: 416-946-4501
  Windsor
 Windsor Regional Cancer Centre at Windsor Regional Hospital
 Contact Person
Ph: 519-253-5253
Quebec
  Greenfield Park
 Hopital Charles Lemoyne
 Contact Person
Ph: 514-466-5000
 Pierre Desjardins
Ph: 450-466-5000
  Montreal
 CHUM - Hotel Dieu Hospital
 Contact Person
Ph: 514-876-6421
 Hopital Notre-Dame du CHUM
 Harold J. Olney
Ph: 514-890-8200
 Maisonneuve-Rosemont Hospital
 Contact Person
Ph: 514-252-3425
 McGill Cancer Centre at McGill University
 Ahmed Galal
Ph: 514-843-1558
 Contact Person
Ph: 514-398-1444
  Quebec City
 Centre Hospitalier Universitaire de Quebec
 Contact Person
Ph: 418-525-4444
 Hopital du Saint-Sacrement - Quebec
 Contact Person
Ph: 418-682-7511
 Guy Cantin
Ph: 418-682-7511
Saskatchewan
  Saskatoon
 Saskatoon Cancer Centre at the University of Saskatchewan
 Contact Person
Ph: 306-655-2684
 Michael Voralia
Ph: 306-655-2925
Croatia
  Zagreb
 University Hospital Rebro
 Contact Person
Ph: 385-1-238-8644
Czech Republic
  Prague
 Thomayer's University Hospital
 Contact Person
Ph: 420-261-082-272
France
  Annecy
 Centre Hospitalier d'Annecy
 Contact Person
Ph: 33-4-5088-3328
  Bayonne
 Centre Hospitalier de la Cote Basque
 Contact Person
Ph: 33-5-5944-3535
  Besancon
 Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
 Contact Person
Ph: 33-3-8166-8166
  Bordeaux
 Institut Bergonie
 Contact Person
Ph: 33-5-5633-3333
  Boucher
 Polyclinique Bordeaux Nord Aquitaine
 Contact Person
Ph: 33-5-5643-7354
  Bourg En Bresse
 C.H. Bourg En Bresse
 Contact Person
Ph: 33-4-7445-4647
  Caen
 Centre Regional Francois Baclesse
 Contact Person
Ph: 33-2-3145-5000
 CHU de Caen
 Contact Person
Ph: 33-2-3127-2508
 Polyclinique Du Parc
 Contact Person
Ph: 33-2-31-82-82-82
  Chambery
 Centre Hospitalier Regional de Chambery
 Contact Person
Ph: 33-4-7996-5050
  Clamart
 Hopital Antoine Beclere
 Contact Person
Ph: 33-1-4537-4444
 Hopital d'Instruction des Armees Percy
 Contact Person
Ph: 33-1-4146-6000
  Clermont-Ferrand
 CHR Clermont Ferrand, Hotel Dieu
 Contact Person
Ph: 33-73-316-000
  Colmar
 Hopital Louis Pasteur
 Contact Person
Ph: 33-3-8980-4102
  Corbeil
 Centre Hospitalier Sud Francilien - Site Corbeil
 Contact Person
Ph: 33-1-6913-6000
  Creteil
 Centre Hospitalier Universitaire Henri Mondor
 Contact Person
Ph: 33-1-4981-2111
  Dijon
 Hopital Du Bocage
 Contact Person
Ph: 33-3-8029-3031
  Grenoble
 Institut Prive de Cancerologie
 Contact Person
Ph: 33-4-763-35-500
  Le Chesnay
 Hopital Andre Mignot
 Contact Person
Ph: 33-1-3963-8909
  Lille
 Centre Hospitalier Regional et Universitaire de Lille
 Contact Person
Ph: 33-3-2044-4255
 Hopital Saint Antoine Lille
 Contact Person
Ph: 33-20-78-31-31
  Limoges
 Centre Hospital Regional Universitaire de Limoges
 Contact Person
Ph: 33-5-5505-6213
  Lyon
 Centre Leon Berard
 Contact Person
Ph: 33-4-7878-2828
 Hopital Edouard Herriot - Lyon
 Contact Person
Ph: 33-4-7211-7300
  Marseille
 Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
 Contact Person
Ph: 33-4-9122-3333
  Meaux
 Centre Hospitalier de Meaux
 Contact Person
Ph: 33-5-6435-3838
  Melun
 Centre Hospitalier Marc Jacquet
 Contact Person
Ph: 33-1-6471-6144
  Metz
 Hopital Notre-Dame de Bon Secours
 Contact Person
Ph: 33-3-8755-3537
  Montpellier
 Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
 Contact Person
Ph: 33-4-6761-3100
  Mulhouse
 Centre Hospitalier de Mulhouse
 Contact Person
Ph: 33-89-647-221
  Nice
 Centre Antoine Lacassagne
 Contact Person
Ph: 33-4-9203-1000
 Hopital de l'Archet CHU de Nice
 Contact Person
Ph: 33-492-036-489
  Paris
 CHU Pitie-Salpetriere
 Contact Person
Ph: 33-1-4217-6060
 Hopital Cochin
 Contact Person
Ph: 33-1-5841-4141
 Hopital Necker
 Contact Person
Ph: 33-1-4449-4000
 Hopital Saint Antoine
 Contact Person
Ph: 33-1-4381-6379
 Hopital Saint-Louis
 Contact Person
Ph: 33-1-4249-4949
 Hotel Dieu de Paris
 Contact Person
Ph: 33-1-4234-8413
 Institut Curie Hopital
 Contact Person
Ph: 33-1-4432-4000
  Pessac
 Hopital Haut Leveque
 Contact Person
Ph: 33-5-5655-6565
  Pierre Benite
 Centre Hospitalier Lyon Sud
 Contact Person
Ph: 33-4-7850-9515
  Pontoise
 Hopital Rene Dubos
 Contact Person
Ph: 33-1-3075-4040
  Reims
 Institut Jean Godinot
 Contact Person
Ph: 33-3-326-504-444
  Rennes
 Hopital Sud
 Contact Person
Ph: 33-02-9928-4321
  Rouen
 Centre Henri Becquerel
 Contact Person
Ph: 33-2-3208-2222
  Saint Cloud
 Centre Rene Huguenin
 Contact Person
Ph: 33-1-4744-1501
  Saint Etienne
 CHU Sainte-Etienne - Hopital Bellevue
 Contact Person
Ph: 33-4-7782-8000
  Saint Germain-en-Laye
 Hopital de Saint Germain-en-Laye
 Contact Person
Ph: 33-397-392-01
  Strasbourg
 Hopital Universitaire Hautepierre
 Contact Person
Ph: 33-3-8812-8000
  Suresnes
 Hopital Foch
 Contact Person
Ph: 33-1-4772-9191
  Valence
 Centre Hospitalier Valence
 Contact Person
Ph: 33-4-7575-7575
  Valenciennes
 Centre Hospitalier de Valenciennes
 Contact Person
Ph: 33-3-2714-3333
  Vandoeuvre-Les-Nancy
 CHU de Nancy - Hopitaux de Brabois
 Contact Person
Ph: 33-3-8315-3030
  Villejuif
 Hopital Paul Brousse
 Contact Person
Ph: 33-1-4559-3000
 Institut Gustave Roussy
 Contact Person
Ph: 33-1-4211-4211
Hungary
  Budapest
 National Institute of Oncology
 Contact Person
Ph: 36-1-224-8766
Netherlands
  Amersfoort
 Meander Medisch Centrum
 Contact Person
Ph: 31-33-422-5511
  Amsterdam
 Academisch Medisch Centrum at University of Amsterdam
 Contact Person
Ph: 31-20-566-9111
 Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
 Contact Person
Ph: 31-20-512-9111
 Onze Lieve Vrouwe Gasthuis
 Contact Person
Ph: 31-20-599-9111
  Delft
 Reinier de Graaf Group - Delft
 Contact Person
Ph: 31-15-260-4130
  Enschede
 Medisch Spectrum Twente
 Contact Person
Ph: 31-53-487-2000
  Groningen
 University Medical Center Groningen
 Contact Person
Ph: 31-50-361-6161
  Heerlen
 Atrium Medical Centre - Heerlen
 Contact Person
Ph: 31-45-576-6666
  Leiden
 Leiden University Medical Center
 Contact Person
Ph: 31-71-526-9111
  Maastricht
 Academisch Ziekenhuis Maastricht
 Contact Person
Ph: 31-43-387-6543
  Nijmegen
 Universitair Medisch Centrum St. Radboud - Nijmegen
 Contact Person
Ph: 31-24-361-1111
  Roermond
 Saint Laurentius Ziekenhuis
 Contact Person
Ph: 31-475-382-466
  Rotterdam
 Daniel Den Hoed Cancer Center at Erasmus Medical Center
 Contact Person
Ph: 31-10-463-9222
  's-Gravenhage
 HagaZiekenhuis - Locatie Leyenburg
 Contact Person
Ph: 31-70-359-2653
  's-Hertogenbosch
 Jeroen Bosch Ziekenhuis
 Contact Person
Ph: 31-73-699-2000
  Utrecht
 University Medical Center Utrecht
 Contact Person
Ph: 31-30-250-9111
New Zealand
  Auckland
 Auckland City Hospital
 Contact Person
Ph: 64-9-307-4949
  Hamilton
 Waikato Hospital
 Contact Person
Ph: 64-7-839-8666
Poland
  Warsaw
 Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
 Contact Person
Ph: 48-22-64-40-200
Spain
  Barcelona
 Hospital Clinic de Barcelona
 Contact Person
Ph: 34-93-227-5400 ext. 2262
 Hospital de la Santa Cruz i Sant Pau
 Anna Sureda
Ph: 34-93-291-9396
 Hospital Universitari Germans Trias i Pujol
 Contact Person
Ph: 34-93-497-89-25
Sweden
  Gothenburg (Goteborg)
 Sahlgrenska University Hospital
 Contact Person
Ph: 46-31-342-2244
  Linkoping
 University Hospital of Linkoping
 Contact Person
Ph: 46-13-222-000
  Lund
 Lund University Hospital
 Contact Person
Ph: 46-46-177-520
  Stockholm
 Karolinska University Hospital - Huddinge
 Contact Person
Ph: 46-8-746-1000
  Umea
 Umea Universitet
 Contact Person
Ph: 46-90-16-5000
  Uppsala
 Uppsala University Hospital
 Contact Person
Ph: 46-18-611-3402
United Kingdom
England
  Birmingham
 Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
 Contact Person
Ph: 44-121-472-1311
 Raigmore Hospital
 Contact Person
Ph: 44-121-472-1311
  Canterbury
 Kent and Canterbury Hospital
 Contact Person
  Hull
 Hull Royal Infirmary
 Contact Person
Ph: 44-1482-674-542
  Kettering, Northants
 Kettering General Hosptial
 Contact Person
  Leicester
 Leicester Royal Infirmary
 Contact Person
Ph: 44-116-254-1414
  London
 Middlesex Hospital
 David C. Linch
Ph: 44-171-380-9724
  Northwood
 Mount Vernon Cancer Centre at Mount Vernon Hospital
 Contact Person
Ph: 44-1923-844-533
  Nottingham
 Nottingham City Hospital NHS Trust
 Contact Person
Ph: 44-115-969-1169
  Sheffield
 Cancer Research Centre at Weston Park Hospital
 Contact Person
Ph: 44-114-226-5000
  Stafford
 Staffordshire General Hospital
 Contact Person

Registry Information
Official Title BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma
Trial Start Date 2002-08-09
Registered in ClinicalTrials.gov NCT00049595
Date Submitted to PDQ 2002-09-11
Information Last Verified 2009-06-14

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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