Clinical Trial Details

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
Tiana Raveloarivahy (Data Manager) , EORTC Headquarters, Brussels
Laurens Vinckier (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Gaetan de Schaetzen (Senior Clinical Operations 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)
AZ Delta (Roeselare, Belgium)
Academisch Ziekenhuis Maastricht (Maastricht, Netherlands)
Alma Mater Studorium Universita di Bologna - Loc. Ospedala Sant Orsolo (Bologna, Italy)
Alrijne Leiden (Leiden, Netherlands)
Amedeo Avogadro University of Eastern Piedmont-Ospedale Maggiore della Carita (Novara, Italy)
Amsterdam UMC - Locatie AMC (Amsterdam, Netherlands)
Arcispedale Di S. Maria Nuova (Reggio Emilia, Italy)
Assistance Publique - Hopitaux de Paris - CHU Henri Mondor (Creteil, France)
Assistance Publique - Hopitaux de Paris - Hopital Antoine Beclere (Clamart, France)
Assistance Publique - Hopitaux de Paris - Hopital Avicenne (BOBIGNY CEDEX, France)
Assistance Publique - Hopitaux de Paris - Hopital De Bicetre (LE KREMLIN BICETRE CEDEX, France)
Assistance Publique - Hopitaux de Paris - Hopital Necker (PARIS CEDEX 15, France)
Assistance Publique - Hopitaux de Paris - Hopital Saint Antoine (PARIS CEDEX 12, France)
Assistance Publique - Hopitaux de Paris - Hopital Saint-Louis (PARIS CEDEX 10, France)
Assistance Publique - Hopitaux de Paris - Hotel-Dieu De Paris (PARIS CEDEX 04, France)
Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere (PARIS CEDEX 13, France)
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 S. Maria (Terni, Italy)
Azienda Ospedaliera Universitaria Pisana (Pisa, Italy)
Azienda Ospedaliera di Cosenza (Cosenza, 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)
C.H.U. Sart-Tilman (Liege, Belgium)
CH Sud Francilien - Gilles De Corbeil (Corbeil Essonnes, France)
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 - Hopital Sud (SALOUEL, France)
CHU Charleroi - Hopital Andre Vesale (Montigny-Le-Tilleul, 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 Chambery (CHAMBERY CEDEX, 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 Regional-Clinique Saint Joseph (Mons, Belgium)
Centre Hospitalier Rene Dubos (Pontoise, 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)
Diakonessenhuis (Utrecht, Netherlands)
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)
HagaZiekenhuis - locatie Leyweg ('S Gravenhage - Den Haag, Netherlands)
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 Universitaire Brugmann (Brussels, Belgium)
Hopital Universitaires Erasme (Brussels, Belgium)
Hopitaux Universitaires de Strasbourg - Hautepierre (Strasbourg, France)
IRCCS - Fondazione Piemonte Inst di Candiolo (Candiolo (Torino), Italy)
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" (Meldola, 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 (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)
National Cancer Institute - Bratislava (Bratislava, Slovakia)
Nouvel Hopital Estaing (CLERMONT FERRAND CEDEX 1, France)
Onze Lieve Vrouw Gasthuis (Amsterdam, Netherlands)
Ospedale Casa Sollievo Della Sofferenza (San Giovanni Rotondo, Italy)
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 Di Circolo E Fondazione Macchi (Varese, Italy)
Ospedale Garibaldi - Universita Di Catania (Catania, Italy)
Ospedale Generale Regionale (Bolzano, Italy)
Ospedale Maggiore Di Lodi (Lodi, Italy)
Ospedale Niguarda Ca Granda (Milano, Italy)
Ospedale Oncologico A. Businco (Cagliari, Italy)
Ospedale Regionale A. Di Summa (Brindisi, Italy)
Ospedale San Eugenio (Roma, Italy)
Ospedale San Raffaele (Milano, Italy)
Ospedale Santa Maria delle Croci (Ravenna, Italy)
Polyclinique Bordeaux-Nord Aquitaine (BORDEAUX CEDEX, France)
Radiotherapeutisch Instituut Friesland (Leeuwarden, Netherlands)
Reinier De Graaf Gasthuis (Delft, Netherlands)
Rigshospitalet (Copenhagen, Denmark)
Rimini Hospital Unit - Infermi Hospital (Rimini, Italy)
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 - 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)
Universita Di Sassari (Sassari, Italy)
Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
Universitair Ziekenhuis Gent (Gent, Belgium)
University Hospital Centre Zagreb (Zagreb, Croatia)
University Medical Center Groningen (Groningen, Netherlands)
ZNA Middelheim (Antwerpen, Belgium)
ZNA Stuivenberg (Antwerpen, Belgium)
Zuyderland Medisch Centrum, Heerlen (Heerlen, Netherlands)
Centers to be activated CHU François Mitterrand (Dijon, France)
Protocol summary http://clinicaltrials.gov/ct/show/NCT00433433
NCT number NCT00433433
EudraCT 2005-002765-37
Financial Support Academic Fund