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Brief Title: Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver
Official Title: Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver
Study ID: NCT02885753
Brief Summary: Colorectal cancer is the 3rd most common cancer in France and the 2nd cause of death from cancer. Between 30 to 60% of patients develop limited or predominant liver metastases. Surgical resection of these metastases, only curative treatment is not immediately possible in 10-15% of cases. In unresectable patients, current palliative treatments are based on systemic chemotherapy associated or not with the targeted therapies (anti-EGFR (panitumumab), anti-VEGF (bevacizumab)). In this patient population, special attention was paid to intensified treatment regimens in order to improve their efficiency and improving the tumoral response rate, the intensity of the response and its earliness correlate with improved overall and progression-free survival. The intra-arterial use of oxaliplatin coupled with IV chemotherapy has yielded OR levels of 64% in patients having survived one or more lines of chemotherapy IV and 62% in patients who have progressed on oxaliplatin IV. In addition, the HIA administration of oxaliplatin limits systemic and especially neurological toxicities, thanks to a greater hepatic clearance. In conclusion, the combination of systemic chemotherapy, targeted therapy and HIAC with oxaliplatin has showed promising efficacy results associated with good tolerance from the first line onwards. Indeed, we can expect from the Phase II recent data, a control rate close to 100%, with high response rates associated with early maturity and depth responses as well as prolonged survival. However, to date, in the absence of randomized trial testing this combination, this strategy does not have sufficient evidence to be integrated in our routine practices, and HIAC remains limited to a few expert centers in treatment catch-up.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CH D'Abbeville, Abbeville CEDEX, , France
Centre Hospitalier du pays d'Aix, Aix-en-Provence, , France
Hôpital Sud, Amiens, , France
CHU - Hôtel Dieu, Angers, , France
Hôpital Privé d'Antony, Antony, , France
CH d'Auxerre, Auxerre, , France
PRIVE - Sainte Catherine, Avignon, , France
CH - Côte Basque, Bayonne CEDEX, , France
CH de Beauvais, Beauvais, , France
CH Jean Minjoz, Besançon, , France
Centre de Radiothérapie Pierre Curie, Beuvry, , France
Institut Bergonié, Bordeaux CEDEX, , France
PRIVE - Polyclinique Bordeaux Nord, Bordeaux, , France
CMCO Côte d'Opale, Boulogne-sur-Mer, , France
Hôpital Duchenne, Boulogne-sur-Mer, , France
Centre François Baclesse, Caen, , France
PRIVE - Infirmerie Protestante de Lyon, Caluire-et-Cuire, , France
CH William Morey, Chalon-sur-Saône, , France
Hôpital Privé Sainte Marie, Chalon-sur-Saône, , France
Centre Hospitalier Métropole Savoie, Chambéry CEDEX, , France
Hôpital Louis Pasteur, Chartres, , France
Hopitaux Civils de Colmar, Colmar, , France
Clinique Saint Côme, Compiègne CEDEX, , France
CH - Sud Francilien, Corbeil-Essonnes, , France
Hôpital Henri Mondor, Créteil CEDEX, , France
Institut de Cancérologie de Bourgogne - GRRECC, Dijon, , France
Centre Georges-François Leclerc, Dijon, , France
CHU - Hôpital François Mitterand, Dijon, , France
GHM Institut Daniel Hollard, Grenoble CEDEX 1, , France
CH Marne La Vallée-Jossigny - Hôpital André Mignot, Jossigny, , France
Ch - Chd Vendee, La Roche Sur Yon, , France
CHU Grenoble - Hôpital Albert Michallon, La Tronche, , France
Hôpital André Mignot, Le Chesnay, , France
CMC Les Ormeaux, Le Havre, , France
Hôpital de Bicêtre, Le Kremlin-Bicêtre, , France
CH du Mans, Le Mans CEDEX 9, , France
Hôpital Francobritannique, Levallois-Perret, , France
, Longjumeau, , France
Hôpital Edouard Herriot, Lyon, , France
CAC - Léon Bernard, Lyon, , France
CHU La Timone, Marseille CEDEX 5, , France
CH - Saint Joseph, Marseille, , France
PRIVE - Hôpital Européen, Marseille, , France
CH de Meaux, Meaux, , France
Hôpital Belle Isle, Metz, , France
Centre Hospitalier, Montceau-les-Mines, , France
Centre Hospitalier, Montélimar, , France
Centre d'Imagerie médicale du Confluent- IRIS GRIM, Nantes, , France
CHU - Hôtel Dieu, Nantes, , France
Hôpial Privé du Confluent Le Confluent Centre Catherine de Sienne, Nantes, , France
CHR, Orleans, , France
Institut Curie, Paris, , France
Hôpital Saint Antoine, Paris, , France
CHU - Hôpital Européen George Pompidou, Paris, , France
CHU - Saint Louis, Paris, , France
Hôpital Cochin, Paris, , France
PRIVE - Saint Joseph, Paris, , France
CH - Centre Hospitalier de Pau, Pau, , France
CH - Pau, Pau, , France
CH, Perpignan, , France
CHU - Haut Lévêque, Pessac, , France
CH Lyon Sud, Pierre-Bénite CEDEX, , France
CHU, Poitiers, , France
CH René Dubois, Pontoise, , France
CH Annecy Genevois, Pringy, , France
Polyclinique Francheville, Périgueux, , France
CHIC, Quimper, , France
CHU Robert Debré, Reims CEDEX, , France
CHU de Pont Chaillou, Rennes CEDEX 9, , France
CAC - Eugène Marquis, Rennes, , France
Hôpital Drome Nord, Romans-sur-Isère, , France
CHU Charles Nicolle, Rouen CEDEX 01, , France
Clinique Mutualiste de l'Estuaire - Cité Sanitaire, Saint Nazaire, , France
PRIVE - Saint Grégoire, Saint-Grégoire, , France
CAC - ICO Site René Gauducheau, Saint-Herblain, , France
Centre Hospitalier de Saint Malo, Saint-Malo, , France
CHU de Saint Etienne - Hôpital Nord, Saint-Priest-en-Jarez, , France
Chu - Hopital Nord Chu Saint Etienne, Saint-Priest-en-Jarez, , France
Clinique Trenel, Sainte Colombe, , France
CH, Senlis CEDEX, , France
CH, Soissons CEDEX, , France
Centre Paul Strauss, Strasbourg, , France
Hôpitaux du Leman, Thonon-les-Bains, , France
Hôpital Sainte Musse, Toulon, , France
CHU - Rangueil, Toulouse, , France
CHU Nancy-Brabois, Vandœuvre-lès-Nancy, , France
Institut de cancérologie de Lorraine, Vandœuvre-lès-Nancy, , France
CAC - Gustave Roussy, Villejuif, , France
Hôpital Paul BROUSSE, Villejuif, , France
CH - Kantonsspital Baden, Baden, , Switzerland
Name: Julien TAIEB, MD-PhD
Affiliation: HEGP, Paris
Role: PRINCIPAL_INVESTIGATOR