Definition, Criteria, and Methodology for the Assessment of Pathological Complete Response in Neoadjuvant Clinical Trials of Head and Neck Cancer A Scoping Review

Introduction Neoadjuvant treatment for HNC could reduce long-term side effects associated with current treatment regimens. HNC clinical trials have demonstrated pCR in patients receiving neoadjuvant therapy, however, there is a lack of standardised definitions and assessment methodologies for pCR in HNC. Inclusion criteria Worldwide clinical trials investigating neoadjuvant treatment for HNC reporting pCR as a trial outcome or pCR rate in study results. Published guidelines outlining the definition and/or assessment methodologies for pCR in neoadjuvant head and neck cancer clinical trials. Methodology Electronic database (including MEDLINE, Embase, Cochrane Library), clinical trial registries (including ClinicalTrials.gov, ISRCTN, EU Clinical Trials Register), grey literature databases, targeted website searching, and customised Google searching will be utilised. Two investigators, in duplicate, will; assess records against pre-defined eligibility criteria; extract data on both ‘study or guideline characteristics’ and ‘pathological complete response’. Data analysis will be descriptive, and results of data will be tabulated to facilitate interpretation.