Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer
Anderson C, Lee C, Saunders D, Curtis A, Dunlap N, Nangia C, Lee A, Gordon S, Kovoor P, Arevalo-Araujo R, Bar-Ad V, Peddada A, Colvett K, Miller D, Jain A, Wheeler J, Blakaj D, Bonomi M, Agarwala S, Garg M, Worden F, Holmlund J, Brill J, Downs M, Sonis S, Katz S, Buatti J. Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer. Journal Of Clinical Oncology 2019, 37: 3256-3265. PMID: 31618127, PMCID: PMC6881100, DOI: 10.1200/jco.19.01507.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsChemoradiotherapyChemoradiotherapy, AdjuvantCisplatinDouble-Blind MethodFemaleHumansIncidenceMaleMiddle AgedMouth NeoplasmsOntarioOrganometallic CompoundsOropharyngeal NeoplasmsRadiation InjuriesRadiation-Protective AgentsRadiotherapy, Intensity-ModulatedRisk FactorsSeverity of Illness IndexStomatitisTime FactorsTreatment OutcomeUnited StatesConceptsDouble-blind trialOral mucositisRadiation therapyCancer Institute Common Terminology Criteria for Adverse EventsNational Cancer Institute Common Terminology Criteria for Adverse EventsPhase IIbCommon Terminology Criteria for Adverse EventsLocally advanced oral cavityPostoperative intensity-modulated RTToxicity of radiation therapyHead and neck cancerGrades of OMIntensity-modulated RTSevere oral mucositisAdverse events gradePhase III trialsAdvanced oral cavityActive dose levelsClinically meaningful reductionsConcurrent radiotherapyIMRT fractionsSevere OMDebilitating toxicityOropharynx cancerTumor characteristics
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