title: STRATEGIC-1: A multiple-lines, randomized, open-label GERCOR phase III study in patients with unresectable wild-type RAS metastatic colorectal cancer.
abstract: BACKGROUND
  The management of unresectable metastatic colorectal cancer (mCRC) is a comprehensive treatment strategy involving several lines of therapy, maintenance, salvage surgery, and treatment-free intervals. Besides chemotherapy (fluoropyrimidine, oxaliplatin, irinotecan), molecular-targeted agents such as anti-angiogenic agents (bevacizumab, aflibercept, regorafenib) and anti-epidermal growth factor receptor agents (cetuximab, panitumumab) have become available. Ultimately, given the increasing cost of new active compounds, new strategy trials are needed to define the optimal use and the best sequencing of these agents. Such new clinical trials require alternative endpoints that can capture the effect of several treatment lines and be measured earlier than overall survival to help shorten the duration and reduce the size and cost of trials.
  
  
  METHODS
  STRATEGIC-1 is an international, open-label, randomized, multicenter phase III trial designed to determine an optimally personalized treatment sequence of the available treatment modalities in patients with unresectable RAS wild-type mCRC. Two standard treatment strategies are compared: first-line FOLFIRI-cetuximab, followed by oxaliplatin-based second-line chemotherapy with bevacizumab (Arm A) vs. first-line OPTIMOX-bevacizumab, followed by irinotecan-based second-line chemotherapy with bevacizumab, and by an anti-epidermal growth factor receptor monoclonal antibody with or without irinotecan as third-line treatment (Arm B). The primary endpoint is duration of disease control. A total of 500 patients will be randomized in a 1:1 ratio to one of the two treatment strategies.
  
  
  CONCLUSIONS
  The STRATEGIC-1 trial is designed to give global information on the therapeutic sequences in patients with unresectable RAS wild-type mCRC that in turn is likely to have a significant impact on the management of this patient population. The trial is open for inclusion since August 2013.
  
  
  BACKGROUND
  STRATEGIC-1 is registered at Clinicaltrials.gov: NCT01910610, 23 July, 2013. STRATEGIC-1 is registered at EudraCT-No.: 2013-001928-19, 25 April, 2013.
authors.affiliation: Division of Medical Oncology, Institut Hospitalier Franco-Britannique, 4, rue Kleber, 92300, Levallois-Perret, France. benoist.chibaudel@ihfb.org.|GERCOR-IRC (Groupe Coopérateur Multidisciplinaire en Oncologie-Innovative Research Consortium), 151, rue du Faubourg Saint-Antoine, 75011, Paris, France. benoist.chibaudel@ihfb.org.
authors.forename: Benoist
authors.initials: B
authors.lastname: Chibaudel
authors.affiliation: Methodology and quality of life in oncology unit (EA 3181) & Quality of life and cancer clinical research platform, Hospital Saint-Jacques, 2 place Saint Jacques, 25000, Besançon, France. franck.bonnetain@univ-fcomte.fr.
authors.forename: Franck
authors.initials: F
authors.lastname: Bonnetain
authors.affiliation: Division of Medical Oncology, Hospital Henri-Mondor, Assistance Publique des Hôpitaux de Paris, Université Paris Est Créteil, Paris 12, 51 Avenue du Maréchal de Lattre de Tassigny, 94010, Créteil, France. christophe.tournigand@hmn.aphp.fr.
authors.forename: Christophe
authors.initials: C
authors.lastname: Tournigand
authors.affiliation: GERCOR-IRC (Groupe Coopérateur Multidisciplinaire en Oncologie-Innovative Research Consortium), 151, rue du Faubourg Saint-Antoine, 75011, Paris, France. marine.hugdelarauze@gercor.com.fr.
authors.forename: Marine Hug
authors.initials: MH
authors.lastname: de Larauze
authors.affiliation: GERCOR-IRC (Groupe Coopérateur Multidisciplinaire en Oncologie-Innovative Research Consortium), 151, rue du Faubourg Saint-Antoine, 75011, Paris, France. armanddegramont@gmail.com.|New drug Evaluation Laboratory, Centre of Experimental Therapeutics, Department of Oncology, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland. armanddegramont@gmail.com.
authors.forename: Armand
authors.initials: A
authors.lastname: de Gramont
authors.affiliation: INSERM U 775 - Faculté des Sciences Fondamentales et Biomédicales, Centre Universitaire des Saints-Pères, 45 Rue des Saints-Pères, 75006, Paris, France. pierre.laurent-puig@parisdescartes.fr.
authors.forename: Pierre
authors.initials: P
authors.lastname: Laurent-Puig
authors.affiliation: LINCOLN, 4 rue Danjou, 92517 Cedex, Boulogne Billancourt, France. jerome.paget@mel.lincoln.fr.
authors.forename: Jérôme
authors.initials: J
authors.lastname: Paget
authors.affiliation: GERCOR-IRC (Groupe Coopérateur Multidisciplinaire en Oncologie-Innovative Research Consortium), 151, rue du Faubourg Saint-Antoine, 75011, Paris, France. alexandra.hadengue@gercor.com.fr.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Hadengue
authors.affiliation: GERCOR-IRC (Groupe Coopérateur Multidisciplinaire en Oncologie-Innovative Research Consortium), 151, rue du Faubourg Saint-Antoine, 75011, Paris, France. dominique.notelet@gercor.com.fr.
authors.forename: Dominique
authors.initials: D
authors.lastname: Notelet
authors.affiliation: GERCOR-IRC (Groupe Coopérateur Multidisciplinaire en Oncologie-Innovative Research Consortium), 151, rue du Faubourg Saint-Antoine, 75011, Paris, France. Magdalena.benetkiewicz@gercor.com.fr.
authors.forename: Magdalena
authors.initials: M
authors.lastname: Benetkiewicz
authors.affiliation: Division of Medical Oncology, Hospital Saint-Antoine, Assistance Publique des Hôpitaux de Paris, Université Pierre et Marie Curie (UPMC), Paris VI, 184, rue du Faubourg Saint-Antoine,, 75571 Cedex 12, Paris, France. thierry.andre@sat.aphp.fr.
authors.forename: Thierry
authors.initials: T
authors.lastname: André
authors.affiliation: Division of Medical Oncology, Institut Hospitalier Franco-Britannique, 4, rue Kleber, 92300, Levallois-Perret, France. aimerydegramont@gmail.com.
authors.forename: Aimery
authors.initials: A
authors.lastname: de Gramont
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016283:Proto-Oncogene Proteins p21(ras) / Q000235:genetics; D012107:Research Design
chemical_list: D000970:Antineoplastic Agents; D016283:Proto-Oncogene Proteins p21(ras)