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

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	16 to 60	Other	EORTC-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

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

Outcomes

Event-free survival

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

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		2009-02-24