Background: The management of unresectable metastatic colorectal cancer (mCRC) is a comprehensive treatment\nstrategy involving several lines of therapy, maintenance, salvage surgery, and treatment-free intervals. Besides\nchemotherapy (fluoropyrimidine, oxaliplatin, irinotecan), molecular-targeted agents such as anti-angiogenic agents\n(bevacizumab, aflibercept, regorafenib) and anti-epidermal growth factor receptor agents (cetuximab, panitumumab)\nhave become available. Ultimately, given the increasing cost of new active compounds, new strategy trials are needed\nto define the optimal use and the best sequencing of these agents. Such new clinical trials require alternative\nendpoints that can capture the effect of several treatment lines and be measured earlier than overall survival to\nhelp shorten the duration and reduce the size and cost of trials.\nMethods/Design: STRATEGIC-1 is an international, open-label, randomized, multicenter phase III trial designed to\ndetermine an optimally personalized treatment sequence of the available treatment modalities in patients with\nunresectable RAS wild-type mCRC. Two standard treatment strategies are compared: first-line FOLFIRI-cetuximab,\nfollowed by oxaliplatin-based second-line chemotherapy with bevacizumab (Arm A) vs. first-line OPTIMOX-bevacizumab,\nfollowed by irinotecan-based second-line chemotherapy with bevacizumab, and by an anti-epidermal growth factor\nreceptor monoclonal antibody with or without irinotecan as third-line treatment (Arm B). The primary endpoint is\nduration of disease control. A total of 500 patients will be randomized in a 1:1 ratio to one of the two treatment\nstrategies.\nDiscussion: The STRATEGIC-1 trial is designed to give global information on the therapeutic sequences in patients\nwith unresectable RAS wild-type mCRC that in turn is likely to have a significant impact on the management of this\npatient population. The trial is open for inclusion since August 2013.
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