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Table 1 Example template of recommended content for the schedule of enrollment, interventions, and assessments

From: A prospective trial to evaluate the clinical efficacy and safety of neoadjuvant chemotherapy with arsenic trioxide and carboplatin in locally advanced cervical cancer: a study protocol for randomized controlled clinical

Time point

Screening

Adjuvant chemotherapy

Close-out

− t1–0

t1

t2

t3

t4

t5–tx

Enrollment

 Screening

X

     

 Informed consent

X

     

Program

 Cohort 1 (ATO + P)

X

X

X

X

X

X

 Cohort 1 (T + P)

X

X

X

X

X

X

Assessment

 Patients characteristic

X

     

 Medical history

X

     

 Performance status

X

     

 Karnofsky

X

     

 Blood test

 

X

X

X

X

X

 Liver function test

 

X

X

X

X

X

 Kidney function test

 

X

X

X

X

X

 Color Doppler ultrasound

 

X

 

X

 

X

 Tumor markers

 

X

 

X

 

X

 Imaging examination (MRI)

 

X

   

X

 RECIST

     

X

 CTCAE

     

X

Cohort migration

     

X

Combined medication

     

X

  1. Imaging examination contains magnetic resonance imaging (MRI) or computed tomography (CT); tumor markers include the following: AFP alpha-fetoprotein antigen, CEA carcinoembryonic antigen, CA153 cancer antigen 153, CA199 cancer antigen 199, CA125 cancer antigen 125, SCC squamous cell carcinoma antigen, CTCAE Common Terminology Criteria for Adverse Events, ATO arsenic trioxide, T Taxol, C carboplatin