Table 1.

Schedule of visits and assessments

Assessment/procedure*	Enrollment	Allocation	Clinical regimen		Clinical tumor assessment	Completion/early termination visit	Survival follow-up
Time point	–2 week	0	Every 2 weeks	Every 4 weeks	Every 8 weeks		Every 8 weeks
Eligibility screen	X
Informed Consent		X
Randomization		X
Demographic and medical history	X
Cancer treatment history	X
Tumor assessment: carcinoembryonic antigen, and computed tomography or magnetic resonance imaging	X				X	X	X
Eastern Cooperative Oncology Group performance status	X		X			X
Urinalysis	X		X			X
Hematology	X		X			X
Clinical chemistry	X		X			X
Creatinine clearance (calculated)	X		X
Physical examination and vital signs	X		X			X
Weight and height	X		X
Concomitant medications	X		X			X
Adverse events	X		X	X	X	X	X
Study drug administration			X	X
Survival and tumor status/other anticancer treatment							X

*Available data will be collected; no additional diagnostic or monitoring procedures shall be applied to the patients other than routine clinical practice