Table 1

Trial registration data

Primary registry and trial identifying numberClinicalTrials.gov NCT03281499
Date of registration in primary registry21 August 2017
Secondary identifying numbersN/A
Source(s) of monetary or material supportInnovation Fund for Surgical Oncology (IFSO), Department of Surgical Oncology, Princess Margaret Cancer Centre
Primary sponsorUniversity Health Network, Toronto
Secondary sponsor(s)N/A
Contact for public queriesJohn R de Almeida
Contact for scientific queriesJohn R de Almeida
Public titleTransoral Robotic Surgery and Tailored Radiotherapy in Unknown Primary and Small Squamous Cell Head and Neck Cancer
Scientific titleFinding/Identifying Primaries with Neck Disease (FIND) Clinical Trial Protocol: A Study Integrating Transoral Robotic Surgery, Histopathologic Localization, and Tailored De-Intensification of Radiotherapy for Unknown Primary and Small Oropharyngeal Head and Neck Squamous Cell Carcinoma
Countries of recruitmentCanada
Health condition(s) or problem(s) studiedHead and Neck Squamous Cell Carcinoma
Intervention(s)Tailored radiotherapy regimen following transoral robotic surgery
Key inclusion and exclusion criteriaInclusion:
  • Age ≥18

  • Metastatic squamous cell carcinoma (T0,N1-3,M0) to at least one regional lymph node of the neck based on fine needle aspiration biopsy, core biopsy, excisional biopsy, or neck dissection


Exclusion:
  • Evidence of a nasopharyngeal carcinoma, non-cutaneous head and neck squamous cell carcinoma or lymphadenopathy unlikely to originate from a primary oropharyngeal carcinoma.

  • Prior radiotherapy

Study typeInterventional
Date of first enrolment14 September 2017
Target sample size25
Recruitment statusRecruiting
Primary outcome(s)
  • Determination of the rate of out-of-field failures following treatment

Key secondary outcomes
  • Adverse events (AE) monitoring

  • Determination of proportions of occult oropharyngeal cancers identified

  • Determination of the proportion of patients amenable to deintensification treatment

  • Exploration of speech and swallowing performance status