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Brief Title: Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC)
Official Title: Randomized Phase II Study of First-line FOLFIRI Plus Cetuximab for 8 Cycles Followed by Either Single-agent Cetuximab as Maintenance Therapy or Observation in Patients With Wild-type KRAS and NRAS Metastatic Colorectal Cancer
Study ID: NCT02404935
Brief Summary: National multicentric phase II trial evaluating whether single agent cetuximab is effective as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after start of maintenance therapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Gustave Roussy, Villejuif, Ile De France, France
CHU- Hôpital Sud, Amiens, , France
Centre Hospitalier Universitaire d'Angers, Angers, , France
Centre Hospitalier d'Auxerre, Auxerre, , France
Institut Sainte Catherine, Avignon, , France
Centre Hospitalier Intercommunal Cote Basque, Bayonne, , France
Centre Hospitalier de Beauvais, Beauvais, , France
Centre Hospitalier de Blois, Blois, , France
Hôpital Avicenne, Bobigny, , France
Clinqiue Tivoli, Bordeaux, , France
Institut Bergonie, Bordeaux, , France
Centre Hospitalier de Béziers, Béziers, , France
Centre François Baclesse, Caen, , France
Hôpital Côte de nacre, Caen, , France
Centre Hospitalier Jean Rougier, Cahors, , France
Centre Hospitalier Jean Rougier, Cahors, , France
Centre Hospitalier Estaing, Clermont-Ferrand, , France
Hôpital du Bocage, Dijon, , France
Centre Hospitalier de la Dracénie, Draguignan, , France
Clinique du Mousseau, Evry, , France
Centre Hospitalier Intercommunal, Frejus, , France
Centre hospitalier Départemental de Vendée - Les Oudairies, La Roche-sur-Yon, , France
Clinique du Cap d'Or, La Seyne-sur-Mer, , France
Hôpital Bicêtre, Le Kremlin Bicêtre, , France
Centre Oscar Lambret, Lille, , France
Clinique Francois Chenieux, Limoges, , France
CHU de Limoges - Hôpital Dupuytren, Limoges, , France
Centre Léon Bérard, Lyon, , France
Hôpital Privé Clairval, Marseille, , France
Institut Paoli Calmettes, Marseille, , France
Centre Hospitalier Montelimar, Montelimar, , France
Centre de Cancérologie du Grand Montpellier - Clinique Clementville, Montpellier, , France
Institut régional du Cancer Montpellier, Montpellier, , France
Centre Antoine Lacassagne, Nice, , France
Centre Hospitalier d'Orléans La Source, Orléans, , France
Polyclinique Francheville, Perigueux, , France
Hôpital Saint Jean, Perpignan, , France
Centre Hospitalier Lyon Sud, Pierre Bénite, , France
CHU - Robert Debre, Reims, , France
Centre Hospitalier de Romans, Romans, , France
Centre Hospitalier Hôpital Victor Provo, Roubaix, , France
Hôpital Saint Gregoire, Saint Gregoire, , France
Clinique Mutualiste de l'Estuaire, Saint Nazaire, , France
CHU Saint Etienne - Hôpital Nord, Saint-Priest-en-Jarez, , France
Centre Paul Strauss, Strasbourg, , France
Polyclinique de l'Ormeau, Tarbes, , France
Centre Hospitalier Intercommunal de Toulon, Toulon, , France
Name: Valérie Boige, Dr
Affiliation: Gustave Roussy, Cancer Campus, Grand Paris
Role: PRINCIPAL_INVESTIGATOR