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

NCT00049595 | Completed Phase 3

• 8 other identifiers: EORTC-20012GELA-EORTC-20012BNLI-EORTC-20012GELCAB-EORTC-20012NORDICLG-EORTC-20012CAN-NCIC-EORTC-20012ALLG-HD042004-001558-10
• Study Type: interventional
• Target: 552
• Locations: 13 countries
• Sites: 140

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating stage III or stage IV Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have stage III or stage IV Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

adult lymphocyte depletion Hodgkin lymphoma; adult mixed cellularity Hodgkin lymphoma; adult nodular sclerosis Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  from randomization to early discontinuation of protocol treatment, no CR/CRu after 8 cycles, relapse, progression or death

Secondary Outcomes (4)

• Complete response as assessed by Cheson criteria adapted to Hodgkin's lymphoma

  from randomization till end of treatment

• Disease-free survival in patients with complete response

  from the day of first documentation of CR to the day of relapse

• Overall survival

  from the date of randomization to the date of death

• 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

  from one week prior to randomization till 10 years after end of treatment or death

Study Arms (2)

ABVD

ACTIVE COMPARATOR

8 cycles of ABVD

Biological: bleomycin sulfate; Drug: ABVD regimen; Drug: dacarbazine; Drug: doxorubicin hydrochloride; Drug: vinblastine sulfate

BEACOPP

EXPERIMENTAL

4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline

Biological: bleomycin sulfate; Biological: filgrastim; Biological: pegfilgrastim; Drug: BEACOPP regimen; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: prednisone; Drug: procarbazine hydrochloride; Drug: vincristine sulfate

Interventions

bleomycin sulfate BIOLOGICAL

ABVD; BEACOPP

filgrastim BIOLOGICAL

BEACOPP

pegfilgrastim BIOLOGICAL

BEACOPP

ABVD regimen DRUG

ABVD

BEACOPP regimen DRUG

BEACOPP

cyclophosphamide DRUG

BEACOPP

dacarbazine DRUG

ABVD

doxorubicin hydrochloride DRUG

ABVD; BEACOPP

etoposide DRUG

BEACOPP

prednisone DRUG

BEACOPP

procarbazine hydrochloride DRUG

BEACOPP

vinblastine sulfate DRUG

ABVD

vincristine sulfate DRUG

BEACOPP

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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 PATIENT CHARACTERISTICS: Age * 16 to 60 Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * WBC greater than 2,000/mm\^3 * Platelet count greater than 100,000/mm\^3 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 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• Lymphoma Trials Office: collaborator
• Lymphoma Study Association: collaborator
• Grup per l'Estudi dels Limfomes de Catalunya i Balears: collaborator
• NCIC Clinical Trials Group: collaborator
• Australasian Leukaemia and Lymphoma Group: collaborator
• Nordic Lymphoma Group: collaborator

Study Sites (140)

Canberra Hospital

Garran, Australian Capital Territory, 2606, Australia

Location

Nepean Cancer Care Centre at Nepean Hospital

Kingswood, New South Wales, 2747, Australia

Location

Westmead Institute for Cancer Research at Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 3002, Australia

Location

St. Vincent's Hospital - Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Ziekenhuis Netwerk Antwerpen Middelheim

Antwerp, 2020, Belgium

Location

AZ Sint-Jan

Bruges, 8000, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Centre Hospitalier Universitaire Brugmann

Brussels, B 1020, Belgium

Location

Centre Hospitalier Notre Dame - Reine Fabiola

Charleroi, 6000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

Algemeen Ziekenhuis Sint Lucas

Ghent, B-9000, Belgium

Location

Hopital de Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Centre Hospitalier Regional de la Citadelle

Liège, 4000, Belgium

Location

H. Hartziekenhuis - Roeselaere

Roeselare, 8800, Belgium

Location

Clinique Universitaire De Mont-Godinne

Yvoir, 5530, Belgium

Location

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute at University of Alberta

Edmonton, Alberta, T6G 1Z2, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Centre Hospitalier De Dunkerque - CHD

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Moncton Hospital

Moncton, New Brunswick, E1C 6ZB, Canada

Location

Doctor H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Northeastern Ontario Regional Cancer Centre

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, K7L 5P9, Canada

Location

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Edmond Odette Cancer Centre at Sunnybrook

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Windsor Regional Cancer Centre at Windsor Regional Hospital

Windsor, Ontario, N8W 2X3, Canada

Location

Hopital Charles Lemoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Hopital Notre-Dame du CHUM

Montreal, Quebec, H2L 4M1, Canada

Location

CHUM - Hotel Dieu Hospital

Montreal, Quebec, H2L-4M1, Canada

Location

McGill Cancer Centre at McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Hopital du Saint-Sacrement - Quebec

Québec, Quebec, G1S 4L8, Canada

Location

Saskatoon Cancer Centre at the University of Saskatchewan

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

University Hospital Rebro

Zagreb, 41000, Croatia

Location

Thomayer's University Hospital

Prague, 14000, Czechia

Location

Centre Hospitalier d'Annecy

Annecy, 74011 Cedex, France

Location

Centre Hospitalier de la Cote Basque

Bayonne, 64100, France

Location

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Polyclinique Bordeaux Nord Aquitaine

Boucher, 33300, France

Location

C.H. Bourg En Bresse

Bourg-en-Bresse, 01012, France

Location

CHU de Caen

Caen, 14033, France

Location

Polyclinique Du Parc

Caen, 14052, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre Hospitalier Regional de Chambery

Chambéry, 73011, France

Location

Hopital d'Instruction des Armees Percy

Clamart, 92140, France

Location

Hopital Antoine Beclere

Clamart, 92141, France

Location

CHR Clermont Ferrand, Hotel Dieu

Clermont-Ferrand, 63003, France

Location

Hopital Louis Pasteur

Colmar, 68024, France

Location

Centre Hospitalier Sud Francilien - Site Corbeil

Corbeil, 91100, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94010, France

Location

Hopital Du Bocage

Dijon, 21034, France

Location

Institut Prive de Cancerologie

Grenoble, 38100, France

Location

Hopital Andre Mignot

Le Chesnay, 78157, France

Location

Hopital Saint Antoine Lille

Lille, 59000, France

Location

Centre Hospitalier Regional et Universitaire de Lille

Lille, 59037, France

Location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Hopital Edouard Herriot - Lyon

Lyon, 69437, France

Location

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

Centre Hospitalier de Meaux

Meaux, 77104, France

Location

Centre Hospitalier Marc Jacquet

Melun, 77011, France

Location

Hopital Notre-Dame de Bon Secours

Metz, 55038, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Hospitalier de Mulhouse

Mulhouse, 68051, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hopital de l'Archet CHU de Nice

Nice, F-06202, France

Location

Hotel Dieu de Paris

Paris, 75181, France

Location

Institut Curie Hopital

Paris, 75248, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Hopital Cochin

Paris, 75674, France

Location

Hopital Necker

Paris, 75743, France

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Hopital Rene Dubos

Pontoise, 95300, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Hopital Sud

Rennes, 35056, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre Rene Huguenin

Saint-Cloud, 92211, France

Location

CHU Sainte-Etienne - Hopital Bellevue

Saint-Etienne, 42055, France

Location

Hopital de Saint Germain-en-Laye

Saint-Germain-en-Laye, 78104, France

Location

Hopital Universitaire Hautepierre

Strasbourg, 67098, France

Location

Hopital Foch

Suresnes, 92151, France

Location

Centre Hospitalier Valence

Valence, 26000, France

Location

Centre Hospitalier de Valenciennes

Valenciennes, 59300, France

Location

CHU de Nancy - Hopitaux de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Hopital Paul Brousse

Villejuif, 94804, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

National Institute of Oncology

Budapest, 1122, Hungary

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5211 NL, Netherlands

Location

Meander Medisch Centrum

Amersfoort, 3816 CP, Netherlands

Location

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 CX, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Reinier de Graaf Group - Delft

Delft, NL 2600 GA, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7500 KA, Netherlands

Location

University Medical Center Groningen

Groningen, 9713 EZ, Netherlands

Location

Atrium Medical Centre - Heerlen

Heerlen, 6419 PC, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Saint Laurentius Ziekenhuis

Roermond, 6043 CV, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, 3008 AE, Netherlands

Location

HagaZiekenhuis - Locatie Leyenburg

The Hague, 2545 CH, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Auckland City Hospital

Auckland, 1, New Zealand

Location

Waikato Hospital

Hamilton, 2020, New Zealand

Location

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw

Warsaw, 02-781, Poland

Location

Hospital de la Santa Cruz i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitari Germans Trias i Pujol

Barcelona, 08916, Spain

Location

Sahlgrenska University Hospital

Gothenburg (Goteborg), S-413 45, Sweden

Location

University Hospital of Linkoping

Linköping, S-581 85, Sweden

Location

Lund University Hospital

Lund, S-22185, Sweden

Location

Karolinska University Hospital - Huddinge

Stockholm, S-141 86, Sweden

Location

Umea Universitet

Umeå, S-901 85, Sweden

Location

Uppsala University Hospital

Uppsala, S-75185, Sweden

Location

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, B15 2TH, United Kingdom

Location

Raigmore Hospital

Birmingham, England, B15 2TH, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, England, CT2 7NR, United Kingdom

Location

Hull Royal Infirmary

Hull, England, HU3 2KZ, United Kingdom

Location

Kettering General Hosptial

Kettering, England, NNI6 8UZ, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Middlesex Hospital

London, England, WC1E 6HX, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Staffordshire General Hospital

Stafford, England, ST16 3SA, United Kingdom

Location

Related Publications (1)

• Carde P, Karrasch M, Fortpied C, Brice P, Khaled H, Casasnovas O, Caillot D, Gaillard I, Bologna S, Ferme C, Lugtenburg PJ, Morschhauser F, Aurer I, Coiffier B, Meyer R, Seftel M, Wolf M, Glimelius B, Sureda A, Mounier N. Eight Cycles of ABVD Versus Four Cycles of BEACOPPescalated Plus Four Cycles of BEACOPPbaseline in Stage III to IV, International Prognostic Score >/= 3, High-Risk Hodgkin Lymphoma: First Results of the Phase III EORTC 20012 Intergroup Trial. J Clin Oncol. 2016 Jun 10;34(17):2028-36. doi: 10.1200/JCO.2015.64.5648. Epub 2016 Apr 25.

  PMID: 27114593 DERIVED

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Bleomycin; Filgrastim; pegfilgrastim; ABVD protocol; Cyclophosphamide; Dacarbazine; Doxorubicin; Etoposide; Prednisone; Procarbazine; Vinblastine; Vincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Proteins; Biological Factors; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Patrice P. Carde, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

• David C. Linch

  Middlesex Hospital

  STUDY CHAIR

• Marine Divine, MD

  Centre Hospitalier Universitaire Henri Mondor

  STUDY CHAIR

• Anna Sureda

  Hospital de la Santa Cruz i Sant Pau

  STUDY CHAIR

• Ralph M. Meyer, MD, FRCPC

  Margaret and Charles Juravinski Cancer Centre

  STUDY CHAIR

• David Ma, MD

  St Vincent's Hospital

  STUDY CHAIR

• Devinder Gill, MD

  Princess Alexandra Hospital

  STUDY CHAIR

• Bengt Glimelius, MD

  Uppsala University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2002
• First Posted: January 27, 2003
• Study Start: August 1, 2002
• Primary Completion: January 1, 2010
• Last Updated: August 5, 2025

Record last verified: 2025-08

Locations

CR (1); BE (14); AU (7); SE (6); CA (22); FR (55); GB (11); HU (1); NZ (2); CZ (1); NL (16); ES (3); PL (1)