Prospective analysis of UGT1A1 promoter polymorphism for irinotecan dose escalation in metastatic colorectal cancer patients treated with bevacizumab plus FOLFIRI as the first-line setting: study protocol for a randomized controlled trial

Table 1 Schedule of assessments

Assessment/Procedure	Before enrollment (screening)	Clinical regimen		Clinical tumor assessment	Completion/Early termination visit	Survival follow-up
Available data will be collected; no additional diagnostic or monitoring procedures shall be applied to the patients other than routine clinical practice.	Before enrollment (screening)	Clinical regimen		Clinical tumor assessment	Completion/Early termination visit	Survival follow-up
Study week		Every 2 weeks	Every 4 weeks	Every 12 weeks		Every 12 weeks
Informed consent	x
Demographics and medical history	x
Cancer treatment history	x
Urinalysis	x	x			x
Tumor assessment	x			x	x	x
ECOG performance status	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

ISSN: 1745-6215