Table 1 Visit schedule

V0

V1

V2

V3

V4

V5

V6

V7

V8

V9

Survival-

Follow-up

Demography

X

Medical history

X

Oncological history

X

Tumor classification

X

Pregnancy test¹

X

Inclusion / Exclusion

X

Laboratory

X

Biopsy

X

Randomisation

X

Physical examination

X

X

X

X

X

X

X

X

X

Anamnesis

X

X

X

X

X

X

X

X

Endoscopy

X

X²

X²

X²

X²

X²

X²

CT/MRI

X

X²

X²

X²

X²

X²

X²

Concomitant Medication

X

X

X

X

X

X

X

X

X

EORTC QLQ-C30, −STO22, −OG 25-

X

X

X

X

X

X

X

X

OP – Description

X

Post-OP Complication

X

Pathology

X

Reference pathology

X

AE/SAE

X

X

X

Survival

X

X

X

X

X

X

X

X

EOS

or earlier for premature withdrawal