STRATEGIC-1: A multiple-lines, randomized, open-label GERCOR phase III study in patients with unresectable wild-type RAS metastatic colorectal cancer

BMC Cancer

Study Protocol

Christophe Tournigand¹  Thierry André²  Aimery de Gramont³  Benoist Chibaudel⁴  Alexandra Hadengue⁵  Magdalena Benetkiewicz⁵  Dominique Notelet⁵  Marine Hug de Larauze⁵  Armand de Gramont⁶  Pierre Laurent-Puig⁷  Jérôme Paget⁸  Franck Bonnetain⁹ 

[1] 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;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;Division of Medical Oncology, Institut Hospitalier Franco-Britannique, 4, rue Kleber, 92300, Levallois-Perret, France;Division of Medical Oncology, Institut Hospitalier Franco-Britannique, 4, rue Kleber, 92300, Levallois-Perret, France;GERCOR-IRC (Groupe Coopérateur Multidisciplinaire en Oncologie-Innovative Research Consortium), 151, rue du Faubourg Saint-Antoine, 75011, Paris, France;GERCOR-IRC (Groupe Coopérateur Multidisciplinaire en Oncologie-Innovative Research Consortium), 151, rue du Faubourg Saint-Antoine, 75011, Paris, France;GERCOR-IRC (Groupe Coopérateur Multidisciplinaire en Oncologie-Innovative Research Consortium), 151, rue du Faubourg Saint-Antoine, 75011, Paris, France;New drug Evaluation Laboratory, Centre of Experimental Therapeutics, Department of Oncology, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland;INSERM U 775 - Faculté des Sciences Fondamentales et Biomédicales, Centre Universitaire des Saints-Pères, 45 Rue des Saints-Pères, 75006, Paris, France;LINCOLN, 4 rue Danjou, 92517 Cedex, Boulogne Billancourt, France;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;

关键词: Colorectal cancer;    Therapeutics;    Strategy;    RAS;    KRAS;    NRAS;    Clinical trial;   

DOI  :  10.1186/s12885-015-1503-7

 received in 2014-10-27, accepted in 2015-06-19,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundThe 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/DesignSTRATEGIC-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.DiscussionThe 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.Trial registrationSTRATEGIC-1 is registered at Clinicaltrials.gov: NCT01910610, 23 July, 2013. STRATEGIC-1 is registered at EudraCT-No.: 2013-001928-19, 25 April, 2013.

【 授权许可】

CC BY   
© Chibaudel et al. 2015