Study

EORTC-20051-LYMG-H10

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

Ellen Peeters (Clinical Operations Manager), EORTC Headquarters, Brussels
Bart Meulemans (Data Manager), EORTC Headquarters, Brussels
Laurens Vinckier (Pharmacovigilance Manager), EORTC Headquarters, Brussels
Catherine Fortpied (Lead Statistician), 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)
ASST Grande Ospedale Metropolitano Niguarda (Milano, Italy)
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 stichting - 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 Ospedaliero - Universitaria Policlinico di Modena (Modena, Italy)
Azienda Ospedaliero Universitaria Renato Dulbecco-Ospedale Civile Pugliese-Ciaccio (Catanzaro, Italy)
Azienda Ospedaliero-Universitaria di Parma (Parma, Italy)
Azienda Sanitaria Dell'Alto Adige-Ospedale di Bolzano (Bolzano, Italy)
Azienda Sanitaria Universitaria Friuli Centrale (Ospedaliero Universitario "Santa Maria della Misericordia" ) (Udine, 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, France)
CH de Roubaix - Hopital V Provo (Roubaix, France)
CHRU de Besancon - Hopital Jean Minjoz (Besancon, France)
CHU Amiens Picardie - Site Sud (Amiens, France)
CHU Charleroi - Hopital Andre Vesale (Montigny-Le-Tilleul, Belgium)
CHU Clermont Ferrand - Estaing (Clermont Ferrand, France)
CHU Helora - Constantinople (Mons, Belgium)
CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium)
CHU de Bordeaux - Group Hospitalier Sud - Hopital Haut-Lévêque (Pessac, France)
CHU de Lille (Lille, France)
CHU de Limoges - Hopital Dupuytren (Limoges, France)
CHU de Nice - Hopital De L'Archet (Nice, France)
CHU de Troyes (Troyes, France)
Casa di Cura La Maddalena S.P.A. (Palermo, Italy)
Centre Antoine Lacassagne (Nice, France)
Centre Francois Baclesse (CLCC) (Caen, France)
Centre Henri Becquerel (Rouen, 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, 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, France)
Centre Hospitalier de Versailles - Hopital Andre Mignot (Le Chesnay, 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, 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, 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 (Saint Quentin, France)
Hopital Saint-Louis (La Rochelle, France)
Hopitaux Universitaires de Strasbourg - Hautepierre (Strasbourg , France)
IRCCS -Istituto Nazionale Oncologico Candiolo (INOC) (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, France)
Institut Jules Bordet (Anderlecht, Belgium)
Institut Paoli-Calmettes (Marseille, 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 Sassuolo (Sassuolo (MO), Italy)
Ospedale Civile Umberto I (Nocera Inferiore, Italy)
Ospedale Garibaldi - Universita Di Catania (Catania, 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, France)
Radiotherapeutisch Instituut Friesland (Leeuwarden, Netherlands)
Reinier De Graaf Gasthuis (Delft, Netherlands)
Rigshospitalet (Copenhagen, Denmark)
Santa 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)
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