Dose-painting after multi-block endoscopic endonasal surgery in sinonasal tumours: protocol for the SinocaRT randomised phase II trial
Abstract
Introduction: Sinonasal carcinomas are rare malignancies with an overall poor prognosis. These tumours arise in close proximity to vital structures, critical organs and cranial nerves involved in essential sensory and endocrine functions. Although multimodal treatment strategies combining surgery and radiotherapy (RT) are required to maximise the chances of cure while sparing surrounding tissues and reducing the risk of recurrence, they are associated with substantial cumulative morbidity. Building on high conformality and steep gradients of modern dose-painting RT, multidisciplinarity can be exploited on technical inter-disciplinary aspects. In particular, minimally morbid endoscopic endonasal multi-block surgery (EES), together with accurate histosurgical mapping, can be leveraged to individualise target tumour subvolumes delineation by risk level to avoid unnecessarily large irradiation and reduce the morbidity of RT while maintaining or improving local tumour control.
Methods and analysis: We designed a randomised multicentre phase II study to assess whether EES-based histosurgical mapping delineation and optimisation using a dose-painting approach can reduce treatment-related toxicity compared with standard intensity-modulated RT using conventional delineation in sinonasal carcinomas. The primary endpoint is the proportion of patients free from severe clinically significant radiation-induced toxicity involving the nasal mucosa, eyes, auditory system, endocrine system…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 52 participants or records.
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