Multicenter randomized double-blind, placebo-controlled trial GORTEC 2009-01 evaluating the effect of the regenerating agent RGTA on radiodermatitis of head and neck cancer patients

Pre-clinical studies showed that topical OTD70DERM®, a Regenerating Agent functional analogue of glycosaminoglycans could markedly reduce radiation-induced mucosal and cutaneous toxicities. This hypothesis was tested in a randomized, placebo-controlled trial performed in 76 HNC patients receiving radiotherapy plus cetuximab. No significant difference was observed concerning the incidence or duration of grade ≥2 radiodermatitis between the arms. Despite a good pre-clinical rationale, OTD70DERM® did not reduce the incidence and severity of radiodermatitis.

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