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

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 ag...

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Autores principales: Chibaudel, Benoist, Bonnetain, Franck, Tournigand, Christophe, de Larauze, Marine Hug, de Gramont, Armand, Laurent-Puig, Pierre, Paget, Jérôme, Hadengue, Alexandra, Notelet, Dominique, Benetkiewicz, Magdalena, André, Thierry, de Gramont, Aimery
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4490616/
https://www.ncbi.nlm.nih.gov/pubmed/26141683
http://dx.doi.org/10.1186/s12885-015-1503-7
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author Chibaudel, Benoist
Bonnetain, Franck
Tournigand, Christophe
de Larauze, Marine Hug
de Gramont, Armand
Laurent-Puig, Pierre
Paget, Jérôme
Hadengue, Alexandra
Notelet, Dominique
Benetkiewicz, Magdalena
André, Thierry
de Gramont, Aimery
author_facet Chibaudel, Benoist
Bonnetain, Franck
Tournigand, Christophe
de Larauze, Marine Hug
de Gramont, Armand
Laurent-Puig, Pierre
Paget, Jérôme
Hadengue, Alexandra
Notelet, Dominique
Benetkiewicz, Magdalena
André, Thierry
de Gramont, Aimery
author_sort Chibaudel, Benoist
collection PubMed
description 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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spelling pubmed-44906162015-07-04 STRATEGIC-1: A multiple-lines, randomized, open-label GERCOR phase III study in patients with unresectable wild-type RAS metastatic colorectal cancer Chibaudel, Benoist Bonnetain, Franck Tournigand, Christophe de Larauze, Marine Hug de Gramont, Armand Laurent-Puig, Pierre Paget, Jérôme Hadengue, Alexandra Notelet, Dominique Benetkiewicz, Magdalena André, Thierry de Gramont, Aimery BMC Cancer Study Protocol 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. BioMed Central 2015-07-04 /pmc/articles/PMC4490616/ /pubmed/26141683 http://dx.doi.org/10.1186/s12885-015-1503-7 Text en © Chibaudel et al. 2015 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Chibaudel, Benoist
Bonnetain, Franck
Tournigand, Christophe
de Larauze, Marine Hug
de Gramont, Armand
Laurent-Puig, Pierre
Paget, Jérôme
Hadengue, Alexandra
Notelet, Dominique
Benetkiewicz, Magdalena
André, Thierry
de Gramont, Aimery
STRATEGIC-1: A multiple-lines, randomized, open-label GERCOR phase III study in patients with unresectable wild-type RAS metastatic colorectal cancer
title STRATEGIC-1: A multiple-lines, randomized, open-label GERCOR phase III study in patients with unresectable wild-type RAS metastatic colorectal cancer
title_full STRATEGIC-1: A multiple-lines, randomized, open-label GERCOR phase III study in patients with unresectable wild-type RAS metastatic colorectal cancer
title_fullStr STRATEGIC-1: A multiple-lines, randomized, open-label GERCOR phase III study in patients with unresectable wild-type RAS metastatic colorectal cancer
title_full_unstemmed STRATEGIC-1: A multiple-lines, randomized, open-label GERCOR phase III study in patients with unresectable wild-type RAS metastatic colorectal cancer
title_short STRATEGIC-1: A multiple-lines, randomized, open-label GERCOR phase III study in patients with unresectable wild-type RAS metastatic colorectal cancer
title_sort strategic-1: a multiple-lines, randomized, open-label gercor phase iii study in patients with unresectable wild-type ras metastatic colorectal cancer
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4490616/
https://www.ncbi.nlm.nih.gov/pubmed/26141683
http://dx.doi.org/10.1186/s12885-015-1503-7
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