Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/16068
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dc.contributor.authorSegelov, Eva-
dc.contributor.authorWaring, Paul M-
dc.contributor.authorDesai, Jaysesh-
dc.contributor.authorWilson, Kate-
dc.contributor.authorGebski, Val-
dc.contributor.authorThavaneswaran, Subotheni-
dc.contributor.authorElez, Elena-
dc.contributor.authorUnderhill, Craig-
dc.contributor.authorPavlakis, Nick-
dc.contributor.authorChantrill, Lorraine-
dc.contributor.authorNott, Louise-
dc.contributor.authorJefford, Michael-
dc.contributor.authorKhasraw, Mustafa-
dc.contributor.authorDay, Fiona-
dc.contributor.authorWasan, Harpreet-
dc.contributor.authorCiardiello, Fortunato-
dc.contributor.authorKarapetis, Chris-
dc.contributor.authorJoubert, Warren-
dc.contributor.authorvan Hazel, Guy A-
dc.contributor.authorHaydon, Andrew-
dc.contributor.authorPrice, Timothy J-
dc.contributor.authorTejpar, Sabine-
dc.contributor.authorTebburr, Niall C-
dc.contributor.authorShapiro, Jeremy-
dc.date.accessioned2016-07-15T04:55:55Z-
dc.date.available2016-07-15T04:55:55Z-
dc.date.issued2016-05-31-
dc.identifier.citationBMC Cancer 2016; 16(1): 339en_US
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/16068-
dc.description.abstractBACKGROUND: Patients with metastatic colorectal cancer whose disease has progressed on oxaliplatin- and irinotecan-containing regimens may benefit from EGFR-inhibiting monoclonal antibodies if they do not contain mutations in the KRAS gene (are "wild type"). It is unknown whether these antibodies, such as cetuximab, are more efficacious in refractory metastatic colorectal cancer as monotherapy, or in combination with irinotecan. Lack of mutation in KRAS, BRAF and PIK3CA predicts response to EFGR-inhibitors. The ICECREAM trial examines the question of monotherapy versus combination with chemotherapy in two groups of patients: those with a "quadruple wild type" tumour genotype (no mutations in KRAS, NRAS, PI3KCA or BRAF genes) and those with the specific KRAS mutation in codon G13D, for whom possibly EGFR-inhibitor efficacy may be equivalent. METHODS AND DESIGN: ICECREAM is a randomised, phase II, open-label, controlled trial comparing the efficacy of cetuximab alone or with irinotecan in patients with "quadruple wild type" or G13D-mutated metastatic colorectal cancer, whose disease has progressed on, or who are intolerant of oxaliplatin- and fluoropyrimidine-based chemotherapy. The primary endpoint is the 6-month progression-free survival benefit of the treatment regimen. Secondary endpoints are response rate, overall survival, and quality of life. The tertiary endpoint is prediction of outcome with further biological markers. International collaboration has facilitated recruitment in this prospective trial of treatment in these infrequently found molecular subsets of colorectal cancer. DISCUSSION: This unique trial will yield prospective information on the efficacy of cetuximab and whether this is further enhanced with chemotherapy in two distinct populations of patients with metastatic colorectal cancer: the "quadruple wild type", which may 'superselect' for tumours sensitive to EGFR-inhibition, and the rare KRAS G13D mutated tumours, which are also postulated to be sensitive to the drug. The focus on establishing both positive and negative predictive factors for the response to targeted therapy is an attempt to improve outcomes, reduce toxicity and contain treatment costs. Tissue and blood will yield a resource for molecular studies. Recruitment, particularly of patients with the rare G13D mutation, will demonstrate the ability for international collaboration to run prospective trials in small colorectal cancer molecular subgroups. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry: ACTRN12612000901808 , registered 16 August 2012.en_US
dc.subjectColorectal tumoursen_US
dc.subjectCetuximaben_US
dc.subjectIrinotecanen_US
dc.subjectClinical trialen_US
dc.subjectTumour mutationsen_US
dc.titleICECREAM: randomised phase II study of cetuximab alone or in combination with irinotecan in patients with metastatic colorectal cancer with either KRAS, NRAS, BRAF and PI3KCA wild type, or G13D mutated tumoursen_US
dc.typeJournal Articleen_US
dc.identifier.journaltitleBMC Canceren_US
dc.identifier.affiliationAustin Health, Heidelberg, Victoria, Australiaen_US
dc.identifier.affiliationUniversity of New South Wales, Sydney, NSW, Australiaen_US
dc.identifier.affiliationUniversity of Melbourne, Melbourne, Australiaen_US
dc.identifier.affiliationRoyal Melbourne Hospital, Melbourne, Australiaen_US
dc.identifier.affiliationPeter MacCallum Cancer Centre, Melbourne, Australiaen_US
dc.identifier.affiliationVall d'Hebron University Hospital, Barcelona, Spainen_US
dc.identifier.affiliationBorder Medical Oncology, Albury-Wodonga, Australiaen_US
dc.identifier.affiliationNorthern Cancer Institute, Royal North Shore Hospital, University of Sydney, Sydney, Australiaen_US
dc.identifier.affiliationMacarthur Cancer Therapy Centre, Campbelltown Hospital, Sydney, Australiaen_US
dc.identifier.affiliationKinghorn Cancer Centre, Sydney, Australiaen_US
dc.identifier.affiliationRoyal Hobart Hospital, Hobart, Australiaen_US
dc.identifier.affiliationAndrew Love Cancer Centre, Geelong, Australiaen_US
dc.identifier.affiliationCalvary Mater Newcastle, University of Newcastle, Newcastle, Australiaen_US
dc.identifier.affiliationHammersmith Hospital, London, UKen_US
dc.identifier.affiliationOncologia Medica, Seconda Università degli Studi di Napoli, Naples, Italyen_US
dc.identifier.affiliationFlinders Medical Centre, Adelaide, Australiaen_US
dc.identifier.affiliationPrincess Alexandra Hospital, Brisbane, Australiaen_US
dc.identifier.affiliationSir Charles Gairdner Hospital, Perth, Australiaen_US
dc.identifier.affiliationAlfred Hospital, Melbourne, Australiaen_US
dc.identifier.affiliationQueen Elizabeth Hospital, Lyell McEwin Hospital, Adelaide, Australiaen_US
dc.identifier.affiliationUniversity Hospitals Leuven, Campus Gasthuisberg, Leuven, Belgiumen_US
dc.identifier.affiliationCabrini Hospital, Melbourne, Australiaen_US
dc.type.studyortrialRandomized Controlled Clinical Trial/Controlled Clinical Trialen_US
dc.identifier.pubmedurihttps://pubmed.ncbi.nlm.nih.gov/27246726en_US
dc.identifier.doi10.1186/s12885-016-2389-8en_US
dc.type.contentTexten_US
dc.type.austinJournal Articleen_US
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.cerifentitytypePublications-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.openairetypeJournal Article-
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