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Table 1 Assessment schedule

From: 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

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 testa 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 CTb (X)      X    X     X
 PET-CTc       (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           
  1. a within 14 days before the start of stereotaxic radiotherapy
  2. 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
  3. cIn case of local, regional, locoregional and / or distant recurrence, patients will be followed only for vital status