Spots Global Cancer Trial Database for Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR
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Trial Identification
Brief Title: Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR
Official Title: Phase III, Multicenter, Open-label, Randomized Trial of Tarceva® vs Chemotherapy in Patients With Advanced NSCLC With Mutations in the TK Domain of the EGFR
Study ID: NCT00446225
Conditions
Study Description
Brief Summary: A Phase III, multicenter, open-label, randomized trial of Erlotinib (Tarceva®) versus chemotherapy in patients with advanced NSCLC with mutations in the Tyrosine Kinase (TK) domain of the EGFR.
Detailed Description: This is a multicenter, phase III, randomized, open-label clinical trial. 146 patients with a diagnosis of advanced (stage IIIB and stage IV), non-squamous-cell, non-small-cell pulmonary carcinoma not treated previously for their disease with chemotherapy who present mutation in the tyrosine kinase domain of the epidermal growth factor receptor, EGFR will be recluted. The primary objective is to compare the progression-free survival in both treatment arms of the study (conventional chemotherapy vs. erlotinib) in patients with non-squamous-cell, non-small-cell lung cancer (NSCLC) in advanced stage (stages IIIB and stage IV) who have not received previous chemotherapy for their disease and who present mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Centre Hospitalier Universitaire D'Angers, Angers, , France
Hôpital Auguste Morvan, Brest, , France
Centre François Baclesse, Caen, , France
Centre Hospitalier René Dubos, Cergy Pontoise, , France
Centre Hospitalier Intercommunal, Creteil, , France
Hôpital A. Mignot, Le Chesnay, , France
Centre Hospitalier Du Mans, Le Mans, , France
Centre Oscar Lambret, Lille, , France
Hôpital du Cluzeau, Limoges, , France
Centre Hospitalier Régional, Longjumeau, , France
Centre Hospitalier de Meaux, Meaux, , France
Centre Hospitalier de Mulhouse, Mulhouse, , France
Hôpital Saint Antoine, Paris, , France
Centre Hospitalier, Perigueux, , France
Centre Hospitalier de La Région D'Annecy, Pringy, , France
CHU Rennes Hôpital Ponchaillou, Rennes, , France
Centre Hosiptalier Genéral de Roanne, Roanne, , France
Institut de Cancérologie de La Loire, St-Priest en Jarez, , France
Hôpital Larrey, Toulouse, , France
CRO di Aviano, Aviano, , Italy
AO Materdomini, Catanzaro, , Italy
AOU Policlinico G. Martino, Messina, , Italy
AO Monaldi, Napoli, , Italy
Casa di Cura "La Maddalena", Palermo, , Italy
Istituti Fisioterapici Ospitalieri, Roma, , Italy
AO S.Camillo Forlanini, Roma, , Italy
Università di Roma "La Sapienza" Az.Policlinico Umb.I°, Roma, , Italy
PO di SS.ma Annunziata, Sassari, , Italy
H. Virgen de los Lirios, Alcoy, Alicante, Spain
H. Torrevieja Salud, Torrevieja, Alicante, Spain
ICO - H. Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital de Mataró, Mataró, Barcelona, Spain
H. Marqués de Valdecilla, Santander, Cantabria, Spain
H. Provincial de Castellón, Castelló de la Plana, Castellón, Spain
Hospital Insular Gran Canaria, Las Palmas De Gran Canaria, Las Palmas, Spain
F.H.Alcorcón, Alcorcon, Madrid, Spain
H. Fuenlabrada, Fuenlabrada, Madrid, Spain
H. Son Dureta, Palma de Mallorca, Mallorca, Spain
H. Ntra. Sra. de la Candelaria, Santa Cruz de Tenerife, Tenerife, Spain
Hospital de Cruces, Baracaldo, Vizcaya, Spain
H.G.U. Alicante, Alicante, , Spain
H. Santa Creu i Sant Pau, Barcelona, , Spain
Instituto Universitario Dexeus, Barcelona, , Spain
H.U.Vall D´Hebrón, Barcelona, , Spain
H. Clinic i Provincial, Barcelona, , Spain
H. Althaia, Barcelona, , Spain
H. Duran i Reynals-ICO, Barcelona, , Spain
H. Reina Sofía, Córdoba, , Spain
ICO Girona -H. Dr. Josep Trueta, Girona, , Spain
H. Virgen de las Nieves, Granada, , Spain
Complejo Hospitalario de Jaén, Jaén, , Spain
Complejo Hosp. Univ. Juan Canalejo, La Coruña, , Spain
Hospital San Millan Y San Pedro, Logroño, , Spain
H. Arnau de Vilanova, Lérida, , Spain
H. de la Princesa, Madrid, , Spain
H. Gregorio Marañón, Madrid, , Spain
H. Ruber Internacional, Madrid, , Spain
H.U. Puerta de Hierro, Madrid, , Spain
Fundación Jimenez Diaz, Madrid, , Spain
Hospial Clinico San Carlos, Madrid, , Spain
H. La Paz, Madrid, , Spain
H. 12 de Octubre, Madrid, , Spain
H. Ramon y Cajal, Madrid, , Spain
H. Carlos Haya, Málaga, , Spain
H.C.Universitario Virgen de la Victoria, Málaga, , Spain
H. Son Llàtzer, Palma de Mallorca, , Spain
Clinica Rotger, Palma de Mallorca, , Spain
H. de Donostia, San Sebastian, , Spain
H. Virgen del Rocío, Sevilla, , Spain
H. Nuestra Sra. de Valme, Sevilla, , Spain
H.C.U.Valencia, Valencia, , Spain
H. General U. de Valencia, Valencia, , Spain
H. Arnau de Vilanova Valencia, Valencia, , Spain
H. Dr. Peset, Valencia, , Spain
H. Miguel Servet, Zaragoza, , Spain
H. Clínico Lozano Blesa, Zaragoza, , Spain
Contact Details
Name: Rafael Rosell i Costa, MD
Affiliation: Spanish Lung Cancer Group
Role: STUDY_CHAIR
Name: Luis Paz-Ares, MD
Affiliation: Spanish Lung Cancer Group
Role: STUDY_CHAIR
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