Study
EORTC-20051-LYMG
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.
Trial Status
LT-FU ongoing
Dates
Date of activation: 19-Oct-2006
Date Step1 close: 24-Jun-2011
Date Step1 close: 24-Jun-2011
Data management at EORTC
Yes
Design
Phase 3
Randomized open label
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
Bleomycin, Cyclophosphamide, Dacarbazine, Doxorubicin, Etoposide, Filgrastim, Prednisone, Procarbazine, Vinblastine, Vincristine
Study Staff
- Catherine Fortpied (Statistician), EORTC Headquarters, Brussels
- Cedric Mallien (Clinical Operations Manager), EORTC Headquarters, Brussels
- Marie-Ange Lentz (Data 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 Della 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 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)
- 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 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)
- 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 L Est Francilien (MEAUX CEDEX, France)
- Grand Hopital de Charleroi - Site Notre Dame (Charleroi, Belgium)
- Grand Hopital de Charleroi - site Saint-Joseph (Gilly, Belgium)
- HUB-Hopital Erasme (Brussels, 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)
- 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)
- 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 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 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)
- Tergooiziekenhuizen - location Blaricum (Blaricum, Netherlands)
- 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)
- ZAS CADIX (Antwerpen, Belgium)
- ZAS Middelheim (Antwerpen, Belgium)
- Zuyderland Medisch Centrum, Heerlen (Heerlen, Netherlands)
Centers to be activated
- CHU François Mitterrand (Dijon, France)
Protocol summary
NCT number
NCT00433433