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| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-20012 | Other Identifier | EORTC | |
| GELA-EORTC-20012 | Other Identifier | GELA | |
| BNLI-EORTC-20012 | Other Identifier | BNLI | |
| GELCAB-EORTC-20012 | Other Identifier | GELCAB | |
| NORDICLG-EORTC-20012 | Other Identifier | NLG | |
| CAN-NCIC-EORTC-20012 | Other Identifier | NCIC CTG | |
| ALLG-HD04 | Other Identifier | ALLG | |
| 2004-001558-10 | EudraCT Number |
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| Name | Class |
|---|---|
| Lymphoma Trials Office | OTHER |
| Lymphoma Study Association | OTHER |
| Grup per l'Estudi dels Limfomes de Catalunya i Balears | OTHER |
| NCIC Clinical Trials Group |
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.
OBJECTIVES:
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.
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.
PROJECTED ACCRUAL: A total of 550 patients (225 per treatment arm) will be accrued for this study within 5.5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABVD | Active Comparator | 8 cycles of ABVD |
|
| BEACOPP | Experimental | 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bleomycin sulfate | Biological |
| ||
| filgrastim |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival | from randomization to early discontinuation of protocol treatment, no CR/CRu after 8 cycles, relapse, progression or death |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
Histologically confirmed Hodgkin's lymphoma
At least 1 bidimensionally measurable target lesion or extranodal lesion
International Prognostic Score of at least 3
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canberra Hospital | Garran | Australian Capital Territory | 2606 | Australia | ||
| Nepean Cancer Care Centre at Nepean Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27114593 | Derived | 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. |
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| NETWORK |
| Australasian Leukaemia and Lymphoma Group | OTHER |
| Nordic Lymphoma Group | NETWORK |
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|
| pegfilgrastim | Biological |
|
| ABVD regimen | Drug |
|
| BEACOPP regimen | Drug |
|
| cyclophosphamide | Drug |
|
| dacarbazine | Drug |
|
| doxorubicin hydrochloride | Drug |
|
| etoposide | Drug |
|
| prednisone | Drug |
|
| procarbazine hydrochloride | Drug |
|
| vinblastine sulfate | Drug |
|
| vincristine sulfate | Drug |
|
| 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 |
| Kingswood |
| New South Wales |
| 2747 |
| Australia |
| Westmead Institute for Cancer Research at Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Princess Alexandra Hospital | Brisbane | Queensland | 4102 | Australia |
| Peter MacCallum Cancer Centre | East Melbourne | Victoria | 3002 | Australia |
| St. Vincent's Hospital - Melbourne | Fitzroy | Victoria | 3065 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| Ziekenhuis Netwerk Antwerpen Middelheim | Antwerp | 2020 | Belgium |
| AZ Sint-Jan | Bruges | 8000 | Belgium |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| Hopital Universitaire Erasme | Brussels | 1070 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| Centre Hospitalier Universitaire Brugmann | Brussels | B 1020 | Belgium |
| Centre Hospitalier Notre Dame - Reine Fabiola | Charleroi | 6000 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | B-2650 | Belgium |
| Algemeen Ziekenhuis Sint Lucas | Ghent | B-9000 | Belgium |
| Hopital de Jolimont | Haine-Saint-Paul | 7100 | Belgium |
| U.Z. Gasthuisberg | Leuven | B-3000 | Belgium |
| Centre Hospitalier Regional de la Citadelle | Liège | 4000 | Belgium |
| H. Hartziekenhuis - Roeselaere | Roeselare | 8800 | Belgium |
| Clinique Universitaire De Mont-Godinne | Yvoir | 5530 | Belgium |
| Tom Baker Cancer Centre - Calgary | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Cancer Institute at University of Alberta | Edmonton | Alberta | T6G 1Z2 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Centre Hospitalier De Dunkerque - CHD | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Moncton Hospital | Moncton | New Brunswick | E1C 6ZB | Canada |
| Doctor H. Bliss Murphy Cancer Centre | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Nova Scotia Cancer Centre | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Northeastern Ontario Regional Cancer Centre | Greater Sudbury | Ontario | P3E 5J1 | Canada |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | Kingston | Ontario | K7L 5P9 | Canada |
| London Regional Cancer Program at London Health Sciences Centre | London | Ontario | N6A 4L6 | Canada |
| Ottawa Hospital Regional Cancer Centre - General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
| Edmond Odette Cancer Centre at Sunnybrook | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Windsor Regional Cancer Centre at Windsor Regional Hospital | Windsor | Ontario | N8W 2X3 | Canada |
| Hopital Charles Lemoyne | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Maisonneuve-Rosemont Hospital | Montreal | Quebec | H1T 2M4 | Canada |
| Hopital Notre-Dame du CHUM | Montreal | Quebec | H2L 4M1 | Canada |
| CHUM - Hotel Dieu Hospital | Montreal | Quebec | H2L-4M1 | Canada |
| McGill Cancer Centre at McGill University | Montreal | Quebec | H2W 1S6 | Canada |
| Centre Hospitalier Universitaire de Quebec | Québec | Quebec | G1R 2J6 | Canada |
| Hopital du Saint-Sacrement - Quebec | Québec | Quebec | G1S 4L8 | Canada |
| Saskatoon Cancer Centre at the University of Saskatchewan | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| University Hospital Rebro | Zagreb | 41000 | Croatia |
| Thomayer's University Hospital | Prague | 14000 | Czechia |
| Centre Hospitalier d'Annecy | Annecy | 74011 Cedex | France |
| Centre Hospitalier de la Cote Basque | Bayonne | 64100 | France |
| Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz | Besançon | 25030 | France |
| Institut Bergonie | Bordeaux | 33076 | France |
| Polyclinique Bordeaux Nord Aquitaine | Boucher | 33300 | France |
| C.H. Bourg En Bresse | Bourg-en-Bresse | 01012 | France |
| CHU de Caen | Caen | 14033 | France |
| Polyclinique Du Parc | Caen | 14052 | France |
| Centre Regional Francois Baclesse | Caen | 14076 | France |
| Centre Hospitalier Regional de Chambery | Chambéry | 73011 | France |
| Hopital d'Instruction des Armees Percy | Clamart | 92140 | France |
| Hopital Antoine Beclere | Clamart | 92141 | France |
| CHR Clermont Ferrand, Hotel Dieu | Clermont-Ferrand | 63003 | France |
| Hopital Louis Pasteur | Colmar | 68024 | France |
| Centre Hospitalier Sud Francilien - Site Corbeil | Corbeil | 91100 | France |
| Centre Hospitalier Universitaire Henri Mondor | Créteil | 94010 | France |
| Hopital Du Bocage | Dijon | 21034 | France |
| Institut Prive de Cancerologie | Grenoble | 38100 | France |
| Hopital Andre Mignot | Le Chesnay | 78157 | France |
| Hopital Saint Antoine Lille | Lille | 59000 | France |
| Centre Hospitalier Regional et Universitaire de Lille | Lille | 59037 | France |
| Centre Hospital Regional Universitaire de Limoges | Limoges | 87042 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Hopital Edouard Herriot - Lyon | Lyon | 69437 | France |
| Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes | Marseille | 13273 | France |
| Centre Hospitalier de Meaux | Meaux | 77104 | France |
| Centre Hospitalier Marc Jacquet | Melun | 77011 | France |
| Hopital Notre-Dame de Bon Secours | Metz | 55038 | France |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Montpellier | 34298 | France |
| Centre Hospitalier de Mulhouse | Mulhouse | 68051 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Hopital de l'Archet CHU de Nice | Nice | F-06202 | France |
| Hotel Dieu de Paris | Paris | 75181 | France |
| Institut Curie Hopital | Paris | 75248 | France |
| Hopital Saint-Louis | Paris | 75475 | France |
| Hopital Saint Antoine | Paris | 75571 | France |
| CHU Pitie-Salpetriere | Paris | 75651 | France |
| Hopital Cochin | Paris | 75674 | France |
| Hopital Necker | Paris | 75743 | France |
| Hopital Haut Leveque | Pessac | 33604 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Hopital Rene Dubos | Pontoise | 95300 | France |
| Institut Jean Godinot | Reims | 51056 | France |
| Hopital Sud | Rennes | 35056 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Centre Rene Huguenin | Saint-Cloud | 92211 | France |
| CHU Sainte-Etienne - Hopital Bellevue | Saint-Etienne | 42055 | France |
| Hopital de Saint Germain-en-Laye | Saint-Germain-en-Laye | 78104 | France |
| Hopital Universitaire Hautepierre | Strasbourg | 67098 | France |
| Hopital Foch | Suresnes | 92151 | France |
| Centre Hospitalier Valence | Valence | 26000 | France |
| Centre Hospitalier de Valenciennes | Valenciennes | 59300 | France |
| CHU de Nancy - Hopitaux de Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| Hopital Paul Brousse | Villejuif | 94804 | France |
| Institut Gustave Roussy | Villejuif | F-94805 | France |
| National Institute of Oncology | Budapest | 1122 | Hungary |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | 5211 NL | Netherlands |
| Meander Medisch Centrum | Amersfoort | 3816 CP | Netherlands |
| Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | Amsterdam | 1066 CX | Netherlands |
| Onze Lieve Vrouwe Gasthuis | Amsterdam | 1091 HA | Netherlands |
| Academisch Medisch Centrum at University of Amsterdam | Amsterdam | 1105 AZ | Netherlands |
| Reinier de Graaf Group - Delft | Delft | NL 2600 GA | Netherlands |
| Medisch Spectrum Twente | Enschede | 7500 KA | Netherlands |
| University Medical Center Groningen | Groningen | 9713 EZ | Netherlands |
| Atrium Medical Centre - Heerlen | Heerlen | 6419 PC | Netherlands |
| Leiden University Medical Center | Leiden | 2300 CA | Netherlands |
| Academisch Ziekenhuis Maastricht | Maastricht | 6202 AZ | Netherlands |
| Universitair Medisch Centrum St. Radboud - Nijmegen | Nijmegen | NL-6500 HB | Netherlands |
| Saint Laurentius Ziekenhuis | Roermond | 6043 CV | Netherlands |
| Daniel Den Hoed Cancer Center at Erasmus Medical Center | Rotterdam | 3008 AE | Netherlands |
| HagaZiekenhuis - Locatie Leyenburg | The Hague | 2545 CH | Netherlands |
| University Medical Center Utrecht | Utrecht | 3584 CX | Netherlands |
| Auckland City Hospital | Auckland | 1 | New Zealand |
| Waikato Hospital | Hamilton | 2020 | New Zealand |
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw | Warsaw | 02-781 | Poland |
| Hospital de la Santa Cruz i Sant Pau | Barcelona | 08025 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitari Germans Trias i Pujol | Barcelona | 08916 | Spain |
| Sahlgrenska University Hospital | Gothenburg (Goteborg) | S-413 45 | Sweden |
| University Hospital of Linkoping | Linköping | S-581 85 | Sweden |
| Lund University Hospital | Lund | S-22185 | Sweden |
| Karolinska University Hospital - Huddinge | Stockholm | S-141 86 | Sweden |
| Umea Universitet | Umeå | S-901 85 | Sweden |
| Uppsala University Hospital | Uppsala | S-75185 | Sweden |
| Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust | Birmingham | England | B15 2TH | United Kingdom |
| Raigmore Hospital | Birmingham | England | B15 2TH | United Kingdom |
| Kent and Canterbury Hospital | Canterbury | England | CT2 7NR | United Kingdom |
| Hull Royal Infirmary | Hull | England | HU3 2KZ | United Kingdom |
| Kettering General Hosptial | Kettering | England | NNI6 8UZ | United Kingdom |
| Leicester Royal Infirmary | Leicester | England | LE1 5WW | United Kingdom |
| Middlesex Hospital | London | England | WC1E 6HX | United Kingdom |
| Mount Vernon Cancer Centre at Mount Vernon Hospital | Northwood | England | HA6 2RN | United Kingdom |
| Nottingham City Hospital NHS Trust | Nottingham | England | NG5 1PB | United Kingdom |
| Cancer Research Centre at Weston Park Hospital | Sheffield | England | S1O 2SJ | United Kingdom |
| Staffordshire General Hospital | Stafford | England | ST16 3SA | United Kingdom |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001761 | Bleomycin |
| D000069585 | Filgrastim |
| C455861 | pegfilgrastim |
| C034632 | ABVD protocol |
| D003520 | Cyclophosphamide |
| D003606 | Dacarbazine |
| D004317 | Doxorubicin |
| D005047 | Etoposide |
| D011241 | Prednisone |
| D011344 | Procarbazine |
| D014747 | Vinblastine |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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