1. STRATEGIC-1: A multiple-lines, randomized, open-label GERCOR phase III study in patients with unresectable wild-type RAS metastatic colorectal cancer
- Author
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Armand de Gramont, Marine Hug de Larauze, Thierry André, Pierre Laurent-Puig, Christophe Tournigand, Magdalena Benetkiewicz, Dominique Notelet, Aimery de Gramont, Alexandra Hadengue, Jérôme Paget, Franck Bonnetain, Benoist Chibaudel, Division of Medical Oncology - Institut Hospitalier Franco-Britannique, Groupe Coopérateur Multidisciplinaire en Oncologie-Innovative Research Consortium ( GERCOR-IRC ), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) ( CEF2P / CARCINO ), Université Bourgogne Franche-Comté [COMUE] ( UBFC ) -Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université de Franche-Comté ( UFC ), AP HP, Département Oncologie, Centre Hospitalier Universitaire Henri Mondor, New drug Evaluation Laboratory, Médecine Personnalisée, Pharmacogénomique, Optimisation Thérapeutique ( MEPPOT - U1147 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), LINCOLN, Service d'Oncologie Médicale, Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Saint-Antoine [APHP], CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Médecine Personnalisée, Pharmacogénomique, Optimisation Thérapeutique (MEPPOT - U1147), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), HAL-UPMC, Gestionnaire, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (UR 3181) (CEF2P / CARCINO), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), and Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)
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Male ,Oncology ,Cancer Research ,medicine.medical_specialty ,Bevacizumab ,Strategy ,Antineoplastic Agents ,[SDV.CAN]Life Sciences [q-bio]/Cancer ,NRAS ,Therapeutics ,[ SDV.CAN ] Life Sciences [q-bio]/Cancer ,Proto-Oncogene Proteins p21(ras) ,Study Protocol ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,[SDV.CAN] Life Sciences [q-bio]/Cancer ,Internal medicine ,Regorafenib ,KRAS ,Genetics ,medicine ,Humans ,Panitumumab ,Aged ,030304 developmental biology ,Aflibercept ,0303 health sciences ,Cetuximab ,business.industry ,Standard treatment ,Middle Aged ,Colorectal cancer ,digestive system diseases ,3. Good health ,Oxaliplatin ,Clinical trial ,Irinotecan ,chemistry ,Research Design ,030220 oncology & carcinogenesis ,Antineoplastic Agents/therapeutic use ,Colorectal Neoplasms/drug therapy ,Colorectal Neoplasms/pathology ,Female ,Proto-Oncogene Proteins p21(ras)/genetics ,Colorectal Neoplasms ,business ,RAS ,medicine.drug - 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/Design 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. Discussion 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. Trial registration STRATEGIC-1 is registered at Clinicaltrials.gov: NCT01910610, 23 July, 2013. STRATEGIC-1 is registered at EudraCT-No.: 2013-001928-19, 25 April, 2013. Electronic supplementary material The online version of this article (doi:10.1186/s12885-015-1503-7) contains supplementary material, which is available to authorized users.
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- 2015
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