Table 2

Study requirements prior to study entry, after study registration and prior to follow-up

Test and proceduresScreeningPresurgerySurgeryAfter TORSRadiotherapy (weekly)End of Treatment (EOT)*Follow-up (q3 months)†End of study (24 months post EOT)‡
Informed consentX
Physical examination including height and weightXXX
Fibreoptic laryngo-pharyngoscopyX
ECOG Performance status assessmentX
PET/CT scanX
CT ChestX
Contrast enhanced CT or MRI—head and neckXXX
FNA of lymph nodeX
Operative examination under anaesthesiaX
Core biopsy of lymph node for EBER and HPV statusX
Pregnancy testX
Performance status for head and neck (PSS-HN) questionnaireX_ XX**_ X
Video-fluoroscopic swallow study and MBS-ImpTM, DIGEST, PCR, & PAS ratingXXX
MDADI questionnaireX_ XX**_ X
NDII questionnaireX_ XX**_ X
Adverse events evaluationXXXXX
Disease evaluationXXXX
Dental evaluationX
  • *End of Treatment assessments are completed on the day of last radiation treatment±5 business days.

  • †Follow-up assessments are done every 3 months±2 weeks.

  • ‡End of Study assessments are done at 24 months after the last radiation treatment ± 4 weeks.

  • §CT Chest at follow up phase is done at 12 months and 24 months post end of treatment.

  • ¶PSS-HN, MDADI and NDII questionnaires are completed within 2–4 weeks from TORS date.

  • **In the follow up phase, the PSS-HN, MDADI and NDII questionnaires are completed at 3, 12 and 24 months after the last radiation treatment.