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Table 5 Study visits in the OPTITREAT trial

From: Immediate tumor resection in patients with locally advanced gastroesophageal adenocarcinoma with nonresponse to chemotherapy after 4 weeks of treatment versus resection after completion of chemotherapy (OPTITREAT trial, DRKS00004668): study protocol for a randomized controlled pilot trial

Documentation

Visit 1

Visit 2

Visit 3

Visit 4

Visit 5

FU

FU

FU

FU

FU

FU

FU

 

Screening

Before CTx

4 weeks after CTx

Before surgery

Discharge

3 months

6 months

9 months

12 months

18 months

24 months

30 months

Baseline data, demographics

X

           

Eligibility criteria

X

           

Endoscopy

 

X

X

         

Clinical response

  

X

         

Randomization

  

X

         

Quality of life

X

  

X

    

X

   

Information about CTx

   

X

        

R0 resection

    

X

       

Histopathological response

    

X

       

Information about surgery

    

X

       

Perioperative morbidity

    

X

X

      

Perioperative mortalitiy

    

X

X

      

Severe adverse events

 

X

X

X

X

X

      

Survival analysis/recurrence

     

X

X

X

X

X

X

X

  1. CTx chemotherapy, FU follow-up