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dc.contributor.authorAvallone, Antonio
dc.contributor.authorPiccirillo, Maria Carmela
dc.contributor.authorAloj, Luigi
dc.contributor.authorNasti, Guglielmo
dc.contributor.authorDelrio, Paolo
dc.contributor.authorIzzo, Francesco
dc.contributor.authorDi Gennaro, Elena
dc.contributor.authorTatangelo, Fabiana
dc.contributor.authorGranata, Vincenza
dc.contributor.authorCavalcanti, Ernesta
dc.contributor.authorMaiolino, Piera
dc.contributor.authorBianco, Francesco
dc.contributor.authorAprea, Pasquale
dc.contributor.authorDe Bellis, Mario
dc.contributor.authorPecori, Biagio
dc.contributor.authorRosati, Gerardo
dc.contributor.authorCarlomagno, Chiara
dc.contributor.authorBertolini, Alessandro
dc.contributor.authorGallo, Ciro
dc.contributor.authorRomano, Carmela
dc.contributor.authorLeone, Alessandra
dc.contributor.authorCaracò, Corradina
dc.contributor.authorde Lutio di Castelguidone, Elisabetta
dc.contributor.authorDaniele, Gennaro
dc.contributor.authorCatalano, Orlando
dc.contributor.authorBotti, Gerardo
dc.contributor.authorPetrillo, Antonella
dc.contributor.authorRomano, Giovanni M
dc.contributor.authorIaffaioli, Vincenzo R
dc.contributor.authorLastoria, Secondo
dc.contributor.authorPerrone, Francesco
dc.contributor.authorBudillon, Alfredo
dc.date.accessioned2018-12-19T00:31:12Z
dc.date.available2018-12-19T00:31:12Z
dc.date.issued2016-02-08
dc.identifier.issn1471-2407
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/287183
dc.description.abstractBACKGROUND: Despite the improvements in diagnosis and treatment, colorectal cancer (CRC) is the second cause of cancer deaths in both sexes. Therefore, research in this field remains of great interest. The approval of bevacizumab, a humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody, in combination with a fluoropyrimidine-based chemotherapy in the treatment of metastatic CRC has changed the oncology practice in this disease. However, the efficacy of bevacizumab-based treatment, has thus far been rather modest. Efforts are ongoing to understand the better way to combine bevacizumab and chemotherapy, and to identify valid predictive biomarkers of benefit to avoid unnecessary and costly therapy to nonresponder patients. The BRANCH study in high-risk locally advanced rectal cancer patients showed that varying bevacizumab schedule may impact on the feasibility and efficacy of chemo-radiotherapy. METHODS/DESIGN: OBELICS is a multicentre, open-label, randomised phase 3 trial comparing in mCRC patients two treatment arms (1:1): standard concomitant administration of bevacizumab with chemotherapy (mFOLFOX/OXXEL regimen) vs experimental sequential bevacizumab given 4 days before chemotherapy, as first or second treatment line. Primary end point is the objective response rate (ORR) measured according to RECIST criteria. A sample size of 230 patients was calculated allowing reliable assessment in all plausible first-second line case-mix conditions, with a 80% statistical power and 2-sided alpha error of 0.05. Secondary endpoints are progression free-survival (PFS), overall survival (OS), toxicity and quality of life. The evaluation of the potential predictive role of several circulating biomarkers (circulating endothelial cells and progenitors, VEGF and VEGF-R SNPs, cytokines, microRNAs, free circulating DNA) as well as the value of the early [(18)F]-Fluorodeoxyglucose positron emission tomography (FDG-PET) response, are the objectives of the traslational project. DISCUSSION: Overall this study could optimize bevacizumab scheduling in combination with chemotherapy in mCRC patients. Moreover, correlative studies could improve the knowledge of the mechanisms by which bevacizumab enhance chemotherapy effect and could identify early predictors of response. EudraCT Number: 2011-004997-27 TRIAL REGISTRATION: ClinicalTrials.gove number, NCT01718873.
dc.format.mediumElectronic
dc.languageeng
dc.publisherSpringer Science and Business Media LLC
dc.rightsAttribution 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.subjectHumans
dc.subjectColorectal Neoplasms
dc.subjectOrganoplatinum Compounds
dc.subjectFluorouracil
dc.subjectLeucovorin
dc.subjectVascular Endothelial Growth Factor A
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectAntibodies, Monoclonal
dc.subjectPrognosis
dc.subjectDisease-Free Survival
dc.subjectAdult
dc.subjectAged
dc.subjectMiddle Aged
dc.subjectFemale
dc.subjectMale
dc.subjectAntibodies, Monoclonal, Humanized
dc.subjectBevacizumab
dc.titleA randomized phase 3 study on the optimization of the combination of bevacizumab with FOLFOX/OXXEL in the treatment of patients with metastatic colorectal cancer-OBELICS (Optimization of BEvacizumab scheduLIng within Chemotherapy Scheme).
dc.typeArticle
prism.publicationDate2016
prism.publicationNameBMC Cancer
prism.startingPage69
prism.volume16
dc.identifier.doi10.17863/CAM.34492
dcterms.dateAccepted2016-01-29
rioxxterms.versionofrecord10.1186/s12885-016-2102-y
rioxxterms.versionVoR
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.licenseref.startdate2016-02-08
dc.contributor.orcidAloj, Luigi [0000-0002-7452-4961]
dc.identifier.eissn1471-2407
rioxxterms.typeJournal Article/Review
cam.issuedOnline2016-02-08


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Attribution 4.0 International
Except where otherwise noted, this item's licence is described as Attribution 4.0 International