A multicenter prospective phase II study of postoperative hypofractionated stereotactic body radiotherapy (SBRT) in the treatment of early-stage oropharyngeal and oral cavity cancers with high risk margins: the STEREO POSTOP GORTEC 2017-03 trial

Table 1 Assessment schedule

TIMEPOINT	Screening/ baseline	Treatment period		Follow-up period
Window	W-4 à W0 Prior SBRT	W2		W3	1 month	3 months	6 months	9 months	12 months	15 months	18 months	21 months	24 months
Day	−28 to −1	8	12 ± 1	14 ± 3	30 ± 5	±10	± 10	±10	±10	±10	±10	±10	±10
Informed consent	X
Medical history and demographic	X
Prior / concomitant medication	X	X	X	X	X
Tumor tissu and HPV Status	X
Pregnancy test^a	X
Physical exam, weight	X	X	X	X	X	X	X	X	X	X	X	X	X
Performance status OMS	X	X	X	X	X	X	X	X	X	X	X	X	X
Dental examination and adapted care	X
ORL exam (mouth, throat and neck)	X				X	X	X	X	X	X	X	X	X
Tumor bed evaluation (clinical +/− nasofibroscopy)	X				X	X	X	X	X	X	X	X	X
Adverse events
Acute toxicity		X	X	X	X	X
Late toxicity							X	X	X	X	X	X	X
Cervico-facial CT or MRI						X			X				X
thoracic CT^b	(X)					X			X				X
PET-CT^c						(X)			(X)				(X)
Quality of Life EORTC QLQ-C30 + HN35	X				X				X				X
SBRT		6*6Gy, 3 days/week in 11 to 13 days

^a within 14 days before the start of stereotaxic radiotherapy
^bTo be repeated at inclusion only if the time between the preoperative thoracic scanner and the start date of radiotherapy is more than 3 months
^cIn case of local, regional, locoregional and / or distant recurrence, patients will be followed only for vital status

ISSN: 1471-2407