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22113 – 08113 Trial design
Treatment
ORTA - Step 1
registration
Histological/Cytologic
al confirmation of
NSCLC
Staging with
CT + FDG-PET/CT
Informed Consent
4D-CT RT planning –
using 3D FDG-
PET/CT
co-matching
Image guided SBRT
with CBCT
verification
7.5 Gy*8 fr = 60 Gy
CT scans
(+ FDG-PET/CT
or biopsy if
required)
RTQA Central Review
(retrospective):
treatment verification CBCT
Upload on EORTC
Radiotherapy platform
RTQA Central Review:
delineation and
treatment planning
Upload on EORTC
Radiotherapy platform
Treatment plan confirmation
will be sent via email to the site
Central Review
Step 2
registration
Expert review 1:
Staging
Eligibility confirmation
will be sent via email
to the site
Upload of images
on EORTC Imaging
platform
Expert review 2:
Eligibility for RT
Follow-up
Maximum 6
weeks from date of
FDG-PET/CT to start of SBRT
3 monthly visits for the
first 3 yrs, 6 monthly for
the 4-5 yrs, and yearly
until the end of the trial
Adebahr et al ,BJR /2015