Finding/identifying primaries with neck disease (FIND) clinical trial protocol: a study integrating transoral robotic surgery, histopathological localisation and tailored deintensification of radiotherapy for unknown primary and small oropharyngeal head and neck squamous cell carcinoma
Wei Xu,
Ilan Weinreb,
John R de Almeida,
Christopher W Noel,
Maria Veigas,
Rosemary Martino,
Douglas B Chepeha,
Scott V Bratman,
David P Goldstein,
Aaron R Hansen,
Eugene Yu,
Ur Metser,
Bayardo Perez-Ordonez,
John Kim
Affiliations
Wei Xu
New Drug Biology and Translational Medicine, Innovent Biologics Inc, Suzhou, Jiangsu, China
Ilan Weinreb
Department of Pathology, University Health Network, Toronto, Ontario, Canada
John R de Almeida
2 Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
Christopher W Noel
Otolaryngology - Head and Neck Surgery, University of Toronto, Toronto, Ontario, Canada
Maria Veigas
3 Department of Biostatistics, Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada
Rosemary Martino
Department of Speech-Language Pathology, University of Toronto Temerty Faculty of Medicine, Toronto, Ontario, Canada
Douglas B Chepeha
7 Otolaryngology -- Head & Neck Surgery, University Health Network, Toronto, Ontario, Canada
Scott V Bratman
Radiation Medicine Program, Princess Margaret Hospital, University Health Network, Toronto, Ontario, Canada
David P Goldstein
1 Department of Otolaryngology–Head and Neck Surgery, Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada
Aaron R Hansen
6 Department of Medical Oncology, Princess Margaret Hospital Cancer Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada
Eugene Yu
7 Department of Neuroradiology and Head and Neck Imaging, Princess Margaret Cancer Cenre, University Health Network, University of Toronto, Toronto, Ontario, Canada
Ur Metser
4 Medical Imaging, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada
Bayardo Perez-Ordonez
Department of Pathology, University Health Network, Toronto, Ontario, Canada
John Kim
2 National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada
Introduction Carcinomas of unknown primary site (CUP) of the head and neck have historically been worked up and managed heterogeneously. Failure to identify a primary site may result in large radiotherapy mucosal volumes. Transoral approaches such as Transoral Robotic Surgery (TORS) may improve the yield of identifying hidden primaries. We aim to assess the oncological and functional outcomes of a combined treatment approach with TORS and tailored radiotherapy.Methods and analysis Twenty-five patients with metastatic squamous cell carcinoma to the neck without clinical or radiographic evidence of a primary site will be enrolled in a phase II trial. Patients will undergo a diagnostic or therapeutic approach with TORS based on specific algorithms incorporating tailored radiotherapy according to the location and laterality of the primary tumour. The primary outcome is to evaluate the out-of-field failure rate over a 2-year period. Secondary outcomes include identification rates, survival outcomes, patient reported outcomes and functional swallowing outcomes.Ethics and dissemination The University Health Network Research Ethics Board approved this study (ID 15–9767). The results will be published in an open access journal.Trial registration number NCT03281499.
