Evidence map›Paper›PMID 26141683›Full record

Trial reportBMC cancer2015

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

Benoist Chibaudel, Franck Bonnetain, Christophe Tournigand, Marine Hug de Larauze, Armand de Gramont, Pierre Laurent-Puig, Jérôme Paget, Alexandra Hadengue, Dominique Notelet, Magdalena Benetkiewicz and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01910610 (Multi-Line Therapy Trial in Unresectable Wild-Type RAS Metastatic Colorectal Cancer. A GERCOR Randomized Open-label Phase III Study.), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01910610 phase3unknown statusnot on this map

Multi-Line Therapy Trial in Unresectable Wild-Type RAS Metastatic Colorectal Cancer. A GERCOR Randomized Open-label Phase III Study.

TypeinterventionalSponsorGERCOR - Multidisciplinary Oncology Cooperative GroupRan2013 to 2024Enrolled464ConditionsColorectal Cancer MetastaticArmsFOLFIRI-cetuximab, mFOLFOX6-bevacizumab, OPTIMOX-bevacizumab, irinotecan-based chemo + bevacizumab, Anti-EGFR agent (cetuximab +/- irinotecan or panitumumab)
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
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  4. Article
  5. Article
  6. Article
  7. Article
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  9. Review
  10. Article
  11. Role of targeted therapy in metastatic colorectal cancer.World journal of gastrointestinal oncology · 2016
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 2 countries.

Benoist ChibaudelDivision of Medical Oncology, Institut Hospitalier Franco-Britannique, 4, rue Kleber, 92300, Levallois-Perret, France. benoist.chibaudel@ihfb.org.
Franck BonnetainMethodology 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.
Christophe TournigandDivision 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.
Marine Hug de LarauzeGERCOR-IRC (Groupe Coopérateur Multidisciplinaire en Oncologie-Innovative Research Consortium), 151, rue du Faubourg Saint-Antoine, 75011, Paris, France. marine.hugdelarauze@gercor.com.fr.
Armand de GramontGERCOR-IRC (Groupe Coopérateur Multidisciplinaire en Oncologie-Innovative Research Consortium), 151, rue du Faubourg Saint-Antoine, 75011, Paris, France. armanddegramont@gmail.com.
Pierre Laurent-PuigINSERM 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.
Jérôme PagetLINCOLN, 4 rue Danjou, 92517 Cedex, Boulogne Billancourt, France. jerome.paget@mel.lincoln.fr.
Alexandra HadengueGERCOR-IRC (Groupe Coopérateur Multidisciplinaire en Oncologie-Innovative Research Consortium), 151, rue du Faubourg Saint-Antoine, 75011, Paris, France. alexandra.hadengue@gercor.com.fr.
Dominique NoteletGERCOR-IRC (Groupe Coopérateur Multidisciplinaire en Oncologie-Innovative Research Consortium), 151, rue du Faubourg Saint-Antoine, 75011, Paris, France. dominique.notelet@gercor.com.fr.
Magdalena BenetkiewiczGERCOR-IRC (Groupe Coopérateur Multidisciplinaire en Oncologie-Innovative Research Consortium), 151, rue du Faubourg Saint-Antoine, 75011, Paris, France. Magdalena.benetkiewicz@gercor.com.fr.
Thierry AndréDivision 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.
Aimery de GramontDivision of Medical Oncology, Institut Hospitalier Franco-Britannique, 4, rue Kleber, 92300, Levallois-Perret, France. aimerydegramont@gmail.com.
Sorbonne Université · FRHôpital Saint-Antoine · FRInstitut Hospitalier Franco Britannique · FRLaboratoire Vision Action Cognition · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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

Indexed as

AgedAntineoplastic AgentsColorectal NeoplasmsFemaleHumansMaleMiddle AgedProto-Oncogene Proteins p21(ras)Research DesignAntineoplastic AgentsProto-Oncogene Proteins p21(ras)

Identifiers

PMID26141683
PMCPMC4490616
OpenAlexW2144583061

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.