Table 2

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

Test and procedures	Screening	Presurgery	Surgery	After TORS	Radiotherapy (weekly)	End of Treatment (EOT)*	Follow-up (q3 months)†	End of study (24 months post EOT)‡
Informed consent	X
Physical examination including height and weight	X						X	X
Fibreoptic laryngo-pharyngoscopy	X
ECOG Performance status assessment	X
PET/CT scan	X
CT Chest							X§	X
Contrast enhanced CT or MRI—head and neck	X						X	X
FNA of lymph node	X
Operative examination under anaesthesia			X
TORS			X
Core biopsy of lymph node for EBER and HPV status	X
Pregnancy test	X
Performance status for head and neck (PSS-HN) questionnaire		X		X¶^_		X	X**^_	X
Video-fluoroscopic swallow study and MBS-ImpTM, DIGEST, PCR, & PAS ratingX		X						X
MDADI questionnaire		X		X¶^_		X	X**^_	X
NDII questionnaire		X		X¶^_		X	X**^_	X
Adverse events evaluation				X	X	X	X	X
Disease evaluation		X				X	X	X
Dental evaluation				X

*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.