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Table 1 Schedule of Assessments

From: SPAR – a randomised, placebo-controlled phase II trial of simvastatin in addition to standard chemotherapy and radiation in preoperative treatment for rectal cancer: an AGITG clinical trial

Treatment Period – Trial Week

 

Baseline / screening

1

2

3

4

5

6

7

13

4–6 weeks post-op

Follow up

Informed consent

X

          

History

X

        

X

 

Physical exam b

X

  

X

 

X

 

X

 

X

 

Trial medication start

 

X

         

Preoperative CRT

  

X

X

X

X

X

X

   

Concomitant meds

X

  

X

 

X

 

X

X

 

X

Trial med compliance

   

X

 

X

 

X

X

  

Adverse events

   

X

 

X

 

X

X

 

X

Haematology

X

 

X

X

X

X

X

X

X

  

Chemistry incl. CRP

X

 

X

X

X

X

X

X

X

  

CEA

X

         

X

Serum pregnancy test

X

          

Resected rectal tissue

         

X

 

CT scan

X

         

X

Pelvic MRI

X

       

X o

  

Lower GI endoscopy

X

         

X

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BMC Cancer

ISSN: 1471-2407

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