Spots Global Cancer Trial Database for Tarceva Italian Lung Optimization tRial
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Trial Identification
Brief Title: Tarceva Italian Lung Optimization tRial
Official Title: Optimization of Erlotinib for the Treatment of Patients With Advanced Non Small Cell Lung Cancer: an Italian Randomized Trial
Study ID: NCT00637910
Conditions
Study Description
Brief Summary: The aim of this study is to assess the superiority of docetaxel in comparison to erlotinib in second line in wild-type EGFR tumour patients.
Detailed Description: Erlotinib is registered in all patients affected with NSCLC in second and subsequent lines with a small benefit on Overall Survival. Recent evidence suggest that patients with EGFR mutations have a clear benefit when they are treated with EGFR tyrosine kinase inhibitors, while the role of these drugs in wild-type EGFR patients, that are representing the large majority (about 85-90%), is still unclear and no properly planned trials assessed before this issue. Recently, indirect evidence on subgroup analyses on randomized trial suggest that chemotherapy might be superior to erlotinib in wild-type EGFR patients. Moreover, several authors do not recommend the use of EGFR determined with immunohistochemistry (IHC) or FISH because they do not reproducibly predict outcome. For these reasons the protocol was amended in May 2011 in a superiority trial of docetaxel versus erlotinib, while the first version was aimed to assess the interaction with biomarkers.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ospedale Civili Riuniti Giovanni Paolo II, Sciacca, Agrigento, Italy
Fabriano Hospital, Fabriano, Ancona, Italy
Ospedali Riuniti Umberto I - Lancisi - Salesi, Torrette, Ancona, Italy
Oncologia A.S.L. AV1, Ariano Irpino, Avellino, Italy
Pesenti-Fenaroli Hospital, Alzano Lombardo, Bergamo, Italy
Ospedale di Vipiteno, Vipiteno, Bolzano, Italy
Oncologia Medica Azienda Spedali Civili, Brescia, BS, Italy
Pneumologia Azienda Spedali Civili, Brescia, BS, Italy
Ospedale centrale di Bolzano, Bolzano, BZ, Italy
Policlinico Universitario di Monserrato, Monserrato, Cagliari, Italy
Ospedale Santa Barbara, Iglesias, Carbonia Iglesias, Italy
Renzetti Hospital, Lanciano, Chieti, Italy
Ospedale S. Elia, Caltanissetta, CL, Italy
San Francesco Hospital, Paola, Cosenza, Italy
Ospedale Civile di Saluzzo Savigliano, Saluzzo, Cuneo, Italy
Istituto Toscano Tumori Ospedale S. Giuseppe Antica Sede, Empoli, Firenze, Italy
Monfalcone Hospital, Monfalcone, Gorizia, Italy
Ospedale Civile Ferrari, Casarano, Lecce, Italy
Ospedale Civile di Casalpusterlengo, Casalpusterlengo, Lodi, Italy
Ospedale S. Maria Goretti, Latina, LT, Italy
B. Eustachio Hospital, San Severino Marche, Macerata, Italy
San Vincenzo Hospital, Taormina, Messina, Italy
Azienda Ospedaliera Melegnano- P.O. Gorgonzola, Gorgonzola, Milano, Italy
Legnano Hospital, Legnano, Milano, Italy
Ospedale Civile di Legnano -Presidio di Magenta, Magenta, Milano, Italy
San Gerardo Hospital, Monza, Milano, Italy
Rho Hospital - Azienda Ospedaliera Salvini-Garbagnate, Rho, Milano, Italy
Policlinico San Donato, San Donato Milanese, Milano, Italy
IRCCS Multimedica, Sesto San Giovanni, Milano, Italy
Ospedale Civile di Vimercate, Vimercate, Milano, Italy
Vizzolo Predabissi Hospital, Vizzolo Predabissi, Milano, Italy
San Leonardo Hospital, Gragnano, Napoli, Italy
Ospedale Civile Vigevano, Vigevano, Pavia, Italy
Policlinico Universitario Palermo, Palermo, PA, Italy
San Massimo Hospital, Penne, Pescara, Italy
Centro di Riferimento Oncologico, Aviano, Pordenone, Italy
Umberto I Hospital, Lugo, Ravenna, Italy
Ospedale Civile di Siderno - ASL n°9 Locri, Siderno, Reggio Calabria, Italy
S. Sebastiano Hospital, Correggio, Reggio Emilia, Italy
Ospedale di Scandiano, Scandiano, Reggio Emilia, Italy
S. Giovanni Evangelista Hospital, Tivoli, Roma, Italy
ASL SA1 -P.O. Umberto I, Nocera Inferiore, Salerno, Italy
Presidio Ospedaliero San Luca, Vallo della Lucania, Salerno, Italy
Ospedale Valdichiana "Nottola", Montepulciano, Siena, Italy
Ospedale Valdelsa "Campostaggia", Poggibonsi, Siena, Italy
Ospedale di Terni, Terni, TR, Italy
Multimedia Santa Maria, Castellanza, Varese, Italy
Azienda Ospedaliera Busto Arsizio, Saronno, Varese, Italy
Umberto I Hospital, Mestre, Venezia, Italy
Ospedale Mater Salutis, Legnago, Verona, Italy
Ospedale Policlinico G.B. Rossi, Verona, VR, Italy
S. Giovanni di Dio Hospital, Agrigento, , Italy
Ospedale San Donato, Arezzo, , Italy
Azienda Ospedaliera Universitaria Consorziale Policlinico, Bari, , Italy
Fatebenefratelli Hospital, Benevento, , Italy
G. Rummo Hospital, Benevento, , Italy
Ospedali Riuniti, Bergamo, , Italy
Armando Businco Oncological Hospital, Cagliari, , Italy
Presidio Ospedaliero Cardarelli ASL 3, Campobasso, , Italy
Sant'Anna Hospital, Como, , Italy
Mariano Santo Hospital, Cosenza, , Italy
Ospedale Maggiore di Crema, Crema, , Italy
S. Croce e Carle Hospital, Cuneo, , Italy
A.O.U. S. Anna, Ferrara, , Italy
A.O.U. Careggi, Firenze, , Italy
Azienda Ospedaliero Universitaria Careggi, Firenze, , Italy
A.O. San Martino, Genova, , Italy
Galliera Hospital, Genova, , Italy
F. Veneziale Hospital, Isernia, , Italy
Azienda Ospedaliera di Lecco, Lecco, , Italy
Fatebenefratelli and Ophthalmic Hospital, Milano, , Italy
Fondazione Ospedale Maggiore Policlinico - Mangiagalli e Regina Elena, Milano, , Italy
San Paolo Hospital, Milano, , Italy
San Carlo Borromeo Hospital, Milano, , Italy
Azienda Ospedaliera Luigi Sacco Polo Universitario, Milano, , Italy
A.O. Monaldi, Napoli, , Italy
Cardarelli Hospital, Napoli, , Italy
D. Cotugno Hospital, Napoli, , Italy
San Gennaro Hospital - ASL NA 1, Napoli, , Italy
Ospedale Maggiore della Carità, Novara, , Italy
Azienda Ospedaliera Universitaria Presidio "Paolo Giaccone", Palermo, , Italy
Presidio Ospedaliero "M. Ascoli" ARNAS Civico, Palermo, , Italy
Centro Oncologico "La Maddalena", Palermo, , Italy
S. Maria della Misericordia Hospital, Perugia, , Italy
Piacenza Hospital, Piacenza, , Italy
S. Maria degli Angeli Hospital, Pordenone, , Italy
Ospedale Civile Santa Maria delle Croci, Ravenna, , Italy
Arcispedale S. Maria Nuova, Reggio Emilia, , Italy
Ospedale San Pietro Fatebenefratelli, Roma, , Italy
Pneumologia Oncologica II-San Camillo Forlanini Hospital, Roma, , Italy
Oncologia Medica-San Camillo Forlanini Hopsital, Roma, , Italy
Università Campus Bio-Medico, Roma, , Italy
Policlinico Umberto I, Roma, , Italy
Policlinico Umberto I, Roma, , Italy
S. Giovanni - Addolorata Hospital, Roma, , Italy
Azienda Ospedaliera S. Giovanni di Dio e Ruggi d'Aragona, Salerno, , Italy
Ospedale Civile SS. Annunziata, Sassari, , Italy
Universita' di Sassari Oncologia Medica, Sassari, , Italy
Ospedale Morelli, Sondrio, , Italy
Sondrio Hospital-Azienda Ospedaliera Valtellina e Valchiavenna, Sondrio, , Italy
A.O.U. San Giovanni Battista Molinette, Torino, , Italy
Ospedale di Circolo, Varese, , Italy
SS. Giovanni e Paolo Hospital, Venezia, , Italy
San Bartolo Hospital, Vicenza, , Italy
Belcolle Hospital, Viterbo, , Italy
Contact Details
Name: Alberto Scanni, MD
Affiliation: Fatebenefratelli and Ophthalmic Hospital
Role: PRINCIPAL_INVESTIGATOR
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