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Phase IIb, randomized, double-blind trial of GC4419 vs placebo to reduce severe oral mucositis due to concurrent radiotherapy and cisplatin for head and neck cancer

Journal of Clinical Oncology Oct 23, 2019

Anderson CM, Lee CM, Saunders DP, et al. - Since oral mucositis (OM) continues to be a common, debilitating toxicity of radiation therapy (RT) for head and neck cancer, therefore, researchers investigated whether GC4419 (a superoxide dismutase mimetic) or placebo affords a better option, in terms of efficacy and safety, for reducing the duration, incidence, and severity of severe OM (SOM). They undertook this phase IIb, multi-institutional, randomized, double-blind trial in 223 patients, recruited from 44 institutions, having locally advanced oral cavity or oropharynx cancer planned to be treated with definitive or postoperative intensity-modulated RT (IMRT) plus cisplatin. The participants were randomly allocated to receive 30 mg (n = 73) or 90 mg (n = 76) of GC4419 or to receive placebo (n = 74) by 60-minute intravenous delivery prior to each IMRT fraction. According to the findings, a significant, clinically meaningful reduction of SOM duration, incidence, and severity was provided by GC4419 at a dose of 90 mg, with acceptable safety.
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