EORTC-20051-LYMG

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The H10 EORTC/GELA/IIL randomized Intergroup trial on early FDG-PET scan guided treatment adaptation versus standard combined modality treatment in patients with supradiaphragmatic stage I/II Hodgkin's lymphoma.

Study documentation

Trial Status	LT-FU ongoing
Dates	Date of activation: 19-Oct-2006 Date Step1 close: 24-Jun-2011
Data management at EORTC	Yes
Design	Phase 3 Randomized open label
Targeted Sample size	EORTC Groups: 950 - All Groups: 1900
Treatment	Radiotherapy, Drug Bleomycin, Cyclophosphamide, Dacarbazine, Doxorubicin, Etoposide, Filgrastim, Prednisone, Procarbazine, Vinblastine, Vincristine
Study Staff	Catherine Fortpied (Statistician) , EORTC Headquarters, Brussels Claire Gandilhon (Clinical Operations Assistant) , EORTC Headquarters, Brussels Marie-Ange Lentz (Data Manager) , EORTC Headquarters, Brussels Cedric Mallien (Clinical Operations Manager) , EORTC Headquarters, Brussels Bart Meulemans (Data Manager) , EORTC Headquarters, Brussels Laurens Vinckier (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Type of cancer	Hodgkins Disease
Participating groups	EORTC Lymphoma Group Italian Lymphoma Foundation Lymphoma Study Association
Recruiting centers	A.Z. St. Jan (Brugge, Belgium) APHP - Hop. Univ. Henri Mondor (Creteil, France) APHP Centre - Univ de Paris Cite - Hopital Hotel-Dieu (PARIS, France) APHP Centre - Univ de Paris Cite- Hopital Necker (PARIS, France) APHP Hop Univ Paris Seine-Saint-Denis- Hop Avicenne (Bobigny, France) APHP Nord - Univ De Paris Cite - Hop. Saint Louis (Paris, France) APHP Sorbonne Univ - Hopital la Pitie-Salpetriere (PARIS, France) APHP Sorbonne Univ- Hopital Saint Antoine (PARIS, France) APHP Univ Paris Saclay - Hopital Antoine Beclere (Clamart, France) APHP Univ Paris Saclay - Hopital Bicetre (Le Kremlin-Bicetre, France) AUSL Dela Romagna - Infermi Hospital -Rimini (Rimini, Italy) AUSL Della Romagna -Ospedale Santa Maria delle Croci (Ravenna, Italy) AZ Delta - Campus Rumbeke (Roeselare, Belgium) Academisch Ziekenhuis Maastricht (Maastricht, Netherlands) Alma Mater Studiorium Universita di Bologna - Loc. Ospedala Sant'Orsolo (Bologna, Italy) Alrijne Leiden (Leiden, Netherlands) Amedeo Avogadro University of Eastern Piedmont-Ospedale Maggiore (Novara, Italy) Amsterdam UMC - Locatie AMC (Amsterdam, Netherlands) Azienda Ospedaliera - Ospedale Di Circolo E Fondazione Macchi (Varese, Italy) Azienda Ospedaliera Bianchi-Melacrino-Morelli (Reggio Calabria, Italy) Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Molinette (Torino, Italy) Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Molinette (Torino, Italy) Azienda Ospedaliera Papardo (Messina, Italy) Azienda Ospedaliera Santa Maria di Terni (Terni, Italy) Azienda Ospedaliera Universitaria Pisana (Pisa, Italy) Azienda Ospedaliera Universitaria Sassari (Sassari, Italy) Azienda Ospedaliera di Cosenza (Cosenza, Italy) Azienda Ospedaliera- Ospedale Niguarda CA' Granda (Milano, Italy) Azienda Ospedaliero - Universitaria Policlinico di Modena (Modena, Italy) Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" di Udine (Udine, Italy) Azienda Ospedaliero-Universitaria di Parma (Parma, Italy) Azienda USL IRCCS Di Reggio Emilia - Maria Nuova (Reggio Emilia, Italy) C.H.U. Sart-Tilman (Liege, Belgium) CH de La Cote Basque - Saint Leon (Bayonne, France) CH de Mulhouse - Hopital Emile Muller-Moenchsberg (MULHOUSE CEDEX 1, France) CH de Roubaix - Hopital V Provo (Roubaix, France) CH de Roubaix - Hopital V Provo (Roubaix, France) CHRU de Besancon - Hopital Jean Minjoz (BESANCON CEDEX, France) CHRU de Lille (LILLE CEDEX, France) CHU Amiens Picardie - Site Sud (Amiens, France) CHU Charleroi - Hopital Andre Vesale (Montigny-Le-Tilleul, Belgium) CHU Clermont Ferrand - Estaing (CLERMONT FERRAND CEDEX 1, France) CHU Helora - Constantinople (Mons, Belgium) CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium) CHU de Bordeaux - Group Hospitalier Sud - Hopital Haut-Lévêque (PESSAC CEDEX, France) CHU de Limoges - Hopital Dupuytren (LIMOGES CEDEX 1, France) CHU de Nice - Hopital De L'Archet (NICE, France) CHU de Troyes (TROYES CEDEX, France) Casa di Cura La Maddalena S.P.A. (Palermo, Italy) Centre Antoine Lacassagne (NICE CEDEX 2, France) Centre Francois Baclesse (CLCC) (CAEN CEDEX 5, France) Centre Henri Becquerel (ROUEN CEDEX, France) Centre Hospitalier D'Aix-En-Provence (Aix-En-Provence, France) Centre Hospitalier De Bourg-En-Bresse (Bourg-En-Bresse, France) Centre Hospitalier De Dunkerque (Dunkerque, France) Centre Hospitalier De Meaux (MEAUX CEDEX, France) Centre Hospitalier De St Germain (St.Germain-En-Laye, France) Centre Hospitalier Marc Jacquet (MELUN CEDEX, France) Centre Hospitalier Rene Dubos (Pontoise, France) Centre Hospitalier Sud Francilien - Gilles De Corbeil (Corbeil Essonnes, France) Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland) Centre Hospitalier Victor Dupouy (ARGENTEUIL CEDEX, France) Centre Hospitalier de Versailles - Hopital Andre Mignot (LE CHESNAY CEDEX, France) Centro Di Riferimento Oncologico (Aviano, Italy) Clinica Ematologica dell'Università di Roma "La Sapienza" (Roma, Italy) Clinica Ematologica dell'Università di Roma "La Sapienza" (Roma, Italy) Clinique Du Mail (Grenoble, France) Clinique Notre-Dame De Grace (Gosselies, Belgium) Clinique Saint-Pierre (Ottignies, Belgium) Cliniques du Sud-Luxembourg - Clinique Saint-Joseph (Arlon, Belgium) Elsan-Polyclinique Du Parc (CAEN CEDEX 4, France) Erasmus MC (Rotterdam, Netherlands) Erasmus MC Hospital (Rotterdam, Netherlands) Fondazione di Ricerca e Cura Giovanni Paolo II - UNiversità Cattolica del Sacro Cuore (Campobasso, Italy) Grand Hopital de Charleroi - Site Notre Dame (Charleroi, Belgium) Grand Hopital de Charleroi - site Saint-Joseph (Gilly, Belgium) Hopital D'Instruction Des Armees Percy (Clamart, France) Hopital Louis Pasteur Chartre (Le Coudray, France) Hopital Nord (APHM) (Marseille, France) Hopital Notre Dame De Bon Secours (METZ, France) Hopital Saint Quentin (ST QUENTIN CEDEX, France) Hopital Saint-Louis (La Rochelle, France) Hopital Universitaires Erasme (Brussels, Belgium) Hopitaux Universitaires de Strasbourg - Hautepierre (Strasbourg Cedex 1, France) IRCCS - Fondazione Piemonte Inst di Candiolo (Candiolo (Torino), Italy) IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" (Meldola, Italy) IRCCS Ospedale San Martino (Genova, Italy) IRCCS Ospedale San Raffaele (Milano, Italy) IRCCS-Regina Elena National Cancer Center (Roma, Italy) Institut Curie - l' Hopital de St Cloud (SAINT CLOUD, France) Institut Curie- Hopital de Paris (PARIS CEDEX 05, France) Institut Jules Bordet (Anderlecht, Belgium) Institut Paoli-Calmettes (MARSEILLE CEDEX 09, France) Institut du Cancer de Montpellier (MONTPELLIER CEDEX 5, France) Isala Klinieken Stichting (Zwolle, Netherlands) Istituto Clinico Humanitas (Rozzano, Milano, Italy) Istituto Di Igiene - Universita Di Milano (Milano, Italy) Istituto Nazionale Per La Ricerca Sul Cancro (Genova, Italy) Laurentius Ziekenhuis Roermond (Roermond, Netherlands) Leiden University Medical Centre (Leiden, Netherlands) Meander Medisch Centrum - De Lichtenberg (Amersfoort, Netherlands) Medisch Centrum Leeuwarden-Zuid (Leeuwarden, Netherlands) Medisch Centrum Leeuwarden-Zuid (Leeuwarden, Netherlands) Medisch Spectrum Twente (Enschede, Netherlands) Narodny Onkologicky Ustav - Bratislava (Bratislava, Slovakia) Onze Lieve Vrouw Gasthuis (Amsterdam, Netherlands) Ospedale Civile Ivrea (Ivrea, Italy) Ospedale Civile Pescara (Pescara, Italy) Ospedale Civile Piacenza (Piacenza, Italy) Ospedale Civile Pugliese-Ciaccio (Catanzaro, Italy) Ospedale Civile Pugliese-Ciaccio (Catanzaro, Italy) Ospedale Civile Sassuolo (Sassuolo (MO), Italy) Ospedale Civile Umberto I (Nocera Inferiore, Italy) Ospedale Garibaldi - Universita Di Catania (Catania, Italy) Ospedale Generale Regionale (Bolzano, Italy) Ospedale Maggiore Di Lodi (Lodi, Italy) Ospedale Oncologico A. Businco (Cagliari, Italy) Ospedale Regionale A. Di Summa (Brindisi, Italy) Ospedale San Eugenio (Roma, Italy) Polyclinique Bordeaux-Nord Aquitaine (BORDEAUX CEDEX, France) Radiotherapeutisch Instituut Friesland (Leeuwarden, Netherlands) Reinier De Graaf Gasthuis (Delft, Netherlands) Rigshospitalet (Copenhagen, Denmark) San Maria della Misericordia Hospital (Perugia, Italy) St. Antonius Ziekenhuis (Nieuwegein, Netherlands) St. Antonius Ziekenhuis (Nieuwegein, Netherlands) Tergooiziekenhuizen - location Blaricum (Blaricum, Netherlands) U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) Universita Degli Studi Di Bari Aldo Moro - - Policlinico (Bari, Italy) Universita Degli Studi Di Roma La Sapienza - Ospedale Sant'Andrea (Roma, Italy) Universita Degli Studi Di Siena -Policlinico "le Scotte" (Siena, Italy) Universitair Ziekenhuis Antwerpen (Edegem, Belgium) Universitair Ziekenhuis Gent (Gent, Belgium) University Hospital Centre Zagreb (Zagreb, Croatia) University Medical Center Groningen (Groningen, Netherlands) ZNA CADIX (Antwerpen, Belgium) ZNA Middelheim (Antwerpen, Belgium) Zuyderland Medisch Centrum, Heerlen (Heerlen, Netherlands)
Centers to be activated	CHU François Mitterrand (Dijon, France)
Protocol summary	http://clinicaltrials.gov/study/NCT00433433
NCT number	NCT00433433
EudraCT	2005-002765-37
Financial Support	Academic Fund