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Brief Title: I-MVAC +/- Panitumumab as First-line Treatment of Advanced Urothelial Carcinoma Without H-Ras Nor K-Ras Mutations
Official Title: Intensified Methotrexate, Vinblastine, Doxorubicin and Cisplatin +/-Panitumumab as First-line Treatment of Advanced Urothelial Carcinoma in Patients Without Harvey Nor Kirsten Rat Sarcoma Viral Oncogene Homolog Mutations. Phase II Study
Study ID: NCT02818725
Brief Summary: OBJECTIVES OF THE TRIAL Primary objective Evaluation of efficacy in terms of progression-free survival at 9 months of the combination of intensified methotrexate, vinblastine, doxorubicin and cisplatin with or without panitumumab as first-line treatment of advanced urothelial carcinoma in patients without Harvey nor Kirsten rat sarcoma viral oncogene homolog mutations. Secondary objectives * To assess toxicity * To assess response rate * To assess overall survival * To assess time to progression * To study the correlation between response rate, time to progression, overall survival and biological parameters
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hopital Saint Andre, Bordeaux, , France
Institut Bergonie, Bordeaux, , France
Centre Francois Baclesse, Caen, , France
Hopital Henri Mondor, Creteil, , France
Centre Leon Berard, Lyon, , France
Institut Paoli Calmettes, Marseille, , France
Centre Alexis Vautrin, Nancy, , France
Centre Rene Gauducheau, Nantes, , France
Chu de Nimes, Nimes, , France
Institut Curie, Paris, , France
Diaconesses - Croix St Simon, Paris, , France
Pitie Salpetriere, Paris, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
Institut Cancerologie de La Loire, St Priest En Jarez, , France
Hopitaux Universitaires, Strasbourg, , France
Institut Claudius Regaud, Toulouse, , France
Institut Gustave Roussy, Villejuif, , France