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Table 1 Schedule of visits and assessments

From: Regorafenib plus FOLFIRI with irinotecan dose escalated according to uridine diphosphate glucuronosyltransferase 1A1genotyping in previous treated metastatic colorectal cancer patients:study protocol for a randomized controlled trial

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

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