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Brief Title: Study of a Treatment Driven by Early PET Response to a Treatment Not Monitored by Early PET in Patients With AA Stage 3-4 or 2B HL
Official Title: Randomized Phase III Study of a Treatment Driven by Early PET Response Compared to a Treatment Not Monitored by Early PET in Patients With Ann Arbor Stage III-IV or High Risk IIB Hodgkin Lymphoma
Study ID: NCT01358747
Brief Summary: All study treatments have proven efficacy in the treatment in Hodgkin lymphoma (HL). It is hoped that patients will achieve a good response to both induction therapies consisting either of 4 cycles of BEACOPPesc (Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Procarbazine, and Prednisone) or 2 cycles of BEACOPPesc plus 2 cycles of ABVD (Adriamycine, Bléomycine, Vinblastine, Décarbazine). The use of F-FDG Position Emission Tomography performed after 2 cycles of chemotherapy (PET2) in the experimental arm will help to stratify patients in order to restrict the BEACOPPesc therapy continuation to those patients who achieved only a partial response after 2 BEACOPPesc regimen and to allow a conventional dose ABVD chemotherapy strategy for PET2 negative patients. For all patients included in the trial the achievement of a good response to induction treatment will be checked after four cycles of induction treatment including a centrally reviewed PET assessment Patients will be randomized after verification of eligibility and before the start of the protocol treatment.Patients will be randomly assigned to the standard treatment arm not monitored by early PET, or the experimental treatment arm driven by the PET2 result.
Detailed Description:
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
ZNA Stuivenberg, Antwerpen, , Belgium
Clinique sud Luxembourg, Arlon, , Belgium
RHMS, Baudour, , Belgium
Az Sint Jan, Bruges, , Belgium
Hôpital Erasme, Bruxelles, , Belgium
Ucl Bruxelles, Bruxelles, , Belgium
Grand hôpital de Charleroi, Charleroi, , Belgium
Hôpital Jolimont, Haine ST Paul, , Belgium
AZ Groeninge, Kortrljk, , Belgium
chu Ambroise Paré, Mons, , Belgium
Clinique St Joseph, Mons, , Belgium
Clinique ST Pierre, Ottignies, , Belgium
AZ Delta, Roeselare, , Belgium
Centre Hospitalier Wallonie Picarde, Tournai, , Belgium
CH tourelle Peltzer, Verviers, , Belgium
Chu Mont Godinne, Yvoir, , Belgium
CHU Angers, Angers, , France
CH Antibes, Antibes, , France
CH Victor Dupouy, Argenteuil, , France
CH d'Arras, Arras, , France
CH Avignon - Hopital Duffaut, Avignon, , France
Hopital de Bayonne, Bayonne, , France
Institut Bergonié, Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine, Bordeaux, , France
CH du Dr Duchenne, Boulogne sur Mer, , France
CH de Bourg en Bresse, Bourg en Bresse, , France
CH Jacques-Coeur, Bourges Cedex, , France
Hôpital Morvan- CHU Brest, Brest, , France
Ch Brive, Brive -la- Gaillarde, , France
CHG Béziers, Béziers, , France
CHU de Caen-Côte de Nacre, Caen, , France
Centre François Baclesse, Caen, , France
Clinique du Parc, Castelnau-le-Lez, , France
Hôpital de Chalon, Chalon sur saône, , France
CH Chambéry, Chambéry, , France
Hopital Antoine Beclere, Clamart, , France
Hôpital d'instruction des Armées Percy, Clamart, , France
Hopitaux Civil de Colmar - Hopital Pasteur, Colmar, , France
CH Sud Francilien, Corbeil-Essonnes, , France
Hopital Henri Mondor, Créteil, , France
CHU Dijon - Hopital du Bocage, Dijon, , France
CH de Dunkerque, Dunkerque, , France
Chd Vendee, La Roche Sur Yon, , France
Hopital Saint Louis, La Rochelle Cedex 1, , France
CH de Versaille - Hopital Mignot, Le Chesnay, , France
CH Chartres - Hopital Louis Pasteur, Le COUDRAY, , France
Hopital Bicetre, Le Kremelin Bicetre, , France
Clinique Victor HUGO, Le Mans, , France
CHU du Mans, Le Mans, , France
CH Lens, Lens, , France
Chru Lille, Lille, , France
CHU de Limoge - Hopital Dupuytren, Limoges, , France
Clinique de la Sauvegarde, Lyon Cedex, , France
Centre Léon Bérard, Lyon, , France
Institut Calmettes, Marseille, , France
Hopital de la conception, Marseille, , France
CH Meaux, Meaux, , France
CH Marc Jacquet, Melun, , France
CHR Metz - Hopital Bon Secours, Metz, , France
CHU Saint-Eloi, Montpellier, , France
CRLC Val D'Aurelle, Montpellier, , France
CH Mulhouse - Hopital Muller, Mulhouse, , France
Centre Catherine de Sienne, Nantes Cedex, , France
CHU Hotel Dieu, Nantes, , France
Hopital Américain de Paris, Neuilly sur Seine, , France
Centre Antoine lacassagne, Nice, , France
CHU Nice - Hopital de l'Archet, Nice, , France
CHU Caremeau, Nimes, , France
CHR de la Source, Orleans, , France
Hopital Cochin, Paris Cedex 14, , France
Hopital Soint-Antoine, Paris, , France
Hôpital ST Antoine, Paris, , France
Institut Curie - Hopital Claudius Régaud, Paris, , France
Hopital Saint-Louis, Paris, , France
Hopital de la Pitié Salpétrière, Paris, , France
Hopital Necker, Paris, , France
CH de Pau, Pau Cedex, , France
Hôpital St Jean, Perpignan, , France
CHU Haut Leveque - Centre François Magendie, Pessac, , France
CHU Lyon Sud, Pierre Bénite, , France
CH Dubos, Pontoise, , France
CH de la région d'Annecy, Pringy, , France
CHU Reims - Hopital Robert Debré, Reims, , France
Pontchaillou, Rennes, , France
Centre Henri Becquerel, Rouen, , France
Clinique Mathilde, Rouen, , France
CH Yves Le Foll, Saint Brieuc Cedex 1, , France
Institut Curie - Hopital Huguenin, Saint-Cloud, , France
Institut de Cancérologie Lucien Neuwirth, St Priest en Jarez, , France
CHU de Strasbourg-Hopital de Hautepierre, Strasbourg, , France
Hôpital Bretonneau, Tours, , France
CH de Troyes, Troyes, , France
CH Valence, Valence, , France
CHU Brabois, Vandoeuvre les Nancy, , France
CH de Bretagne Atlantique, Vannes, , France
Institut Gustave Roussy, Villejuif, , France
Name: René-Olivier CASASNOVAS, MD
Affiliation: CHU Dijon
Role: PRINCIPAL_INVESTIGATOR