Guidelines for preclinical and early phase clinical assessment of novel radiosensitisers

There is a growing appreciation of the potential value of combining novel molecularly-targeted drugs with radiotherapy or chemoradiotherapy. Such approaches have the potential to improve locoregional disease control and cure rates across a diverse range of tumour types. In this report, we outline a rational framework for developing novel drug-radiation combinations. In doing so, we make recommendations regarding the core preclinical data sets that are required to serve as justification for studies in humans and describe potential clinical trial designs that may be adopted by investigators.