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.

Study documentation Back to result

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 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 Universitaires 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)
  • 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