Table 2 Trial flow chart of the SULTAN study

Inclusion / non-inclusion criteria

x

Signed informed consent form

x

Randomization (R)

x

Medical history and prior treatment history

x

Central review (verification on the unresecability of CRLM)

x

 Complete clinical examination & vital signs

x

x

x

x

x

x

 Performance status (ECOG)

x

x

x

x

x

x

 Toxicities/adverse events/signs and symptoms

x

x

x

x

x

x

 Concomitant treatments

x

x

x

x

x

 Thoraco-abdomino and pelvic CT scan and/or liver MRI

x

x

x

 Angiogram or scintigraphic hepatic infusion in the experimental arm

x^b

x^c

 ECG^a

x

x

x

x

 Hematology (neutrophils, platelets, haemoglobin),

x

x

x

x

x

 Biochemistry (including kalemia, magnesemia calcemia, glycemia)

x

x

x

x

x

 Liver function (alkaline phosphatase, total and conjugated bilirubin, AST, ALT, LDH)

x

x

x

x

x

 Albuminemia, Protidemia

x

x

x

x

x

 INR

x

 Renal function (creatininemia, urea, calculated creatine clearance)

x

x

x

x

x

 Proteinuria

x

x^d

x^d

x^d

 Pregnancy test

x

x

x

 Tumor marker: CEA + CA 19.9

x

x

 QLQ-C30 + QLQ-LMC21

x

x

x^e