Spots Global Cancer Trial Database for Efficacy of FOLFOX Alone, FOLFOX Plus Bevacizumab and FOLFOX Plus Panitumumab in Patients With Resectable Liver Metastases
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Trial Identification
Brief Title: Efficacy of FOLFOX Alone, FOLFOX Plus Bevacizumab and FOLFOX Plus Panitumumab in Patients With Resectable Liver Metastases
Official Title: Randomized Phase II Trial Evaluating the Efficacy of FOLFOX Alone, FOLFOX Plus Bevacizumab and FOLFOX Plus Panitumumab as Perioperative Treatment in Patients With Resectable Liver Metastases From Wild Type KRAS/NRAS Colorectal Cancer
Study ID: NCT01508000
Study Description
Brief Summary: Patients presenting with multiple innumerable liver metastases will probably never come to resection, however, for all others, including patients with numerous multiple metastases or large metastases,resection should be considered after limited chemotherapy. There is consensus for a backbone chemotherapy consisting of fluoropyrimidine + oxaliplatin. FOLFOX was used in the previous EORTC study and is again recommended. The addition of targeted agents to standard chemotherapy in the perioperative strategy for mCRC might increase the ORR and R0 resectability, without significant increase in toxicity, therefore translating to a better outcome. It was therefore decided to design an open label, randomized, multi-center, 3-arm late phase II study. Arm A: (standard) mFOLFOX6 + Surgery Arm B: (experimental) mFOLFOX6 + Bevacizumab + Surgery Arm C: (experimental) mFOLFOX6 + Panitumumab + Surgery
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Allgemeines Krankenhaus der Stadt Wien, Vienna, , Austria
Hopital Universitaire Brugmann, Brussels, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
AZ Groeninge Kortrijk - Campus Kennedylaan, Kortrijk, , Belgium
AZ Turnhout - Campus Sint Elisabeth, Turnhout, , Belgium
Centre Hospitalier Peltzer-La Tourelle, Verviers, , Belgium
Institut Sainte Catherine, Avignon, , France
Institut Bergonie, Bordeaux, , France
CHU Ambroise Pare, Boulogne Billancourt, , France
Assistance Publique - Hôpitaux de Paris - Hopital De Bicetre AP-HP, Le Kremlin Bicetre, , France
Centre Hospitalier Saint Joseph Saint Luc, Lyon, , France
Centre Leon Berard, Lyon, , France
Hopital Prive Jean Mermoz, Lyon, , France
Centre Antoine Lacassagne, Nice, , France
Hopital Europeen Georges Pompidou, Paris, , France
Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly, Paris, , France
CHU de Lyon - Centre Hospitalier Lyon Sud, Pierre-Benite (lyon), , France
CHU de Reims - Hôpital Robert Debré, Reims, , France
Hopital Charles Nicolle, Rouen, , France
CHU Saint-Etienne - CHU de Saint-Etienne - Hopital Nord, Saint Priest en Jarez, , France
Centre Hospitalier Privé Saint-Grégoire, Saint-Gregoire, , France
CHU d'Amiens - CHU Amiens - Hopital Sud, Salouel, , France
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam, , Netherlands
Hospital General Vall D'Hebron, Barcelona, , Spain
Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie, Geneve, , Switzerland
Contact Details
Name: Bernard Nordlinger, Pr.
Affiliation: C.H.U. AMBROISE PARE AP-HP, Boulogne-Billancourt, France
Role: STUDY_CHAIR
Name: Stephane Benoist, Pr.
Affiliation: HOPITAL DE BICETRE AP-HP, Le Kremlin Bicetre, France
Role: STUDY_CHAIR
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