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Table 1 Study schedule of enrollment, interventions, and assessments

From: Radiotherapy versus radiotherapy combined with temozolomide in high-risk low-grade gliomas after surgery: study protocol for a randomized controlled clinical trial

 

Study period

Enrollment

Allocation

Post allocation

Time point

−4 weeks

0

Week 0–6

Week 10

Weeks 11–34

Within 2 years

3–5 years

5–10 years

Enrollment:

 Eligibility screen

X

       

 Informed consent

X

       

 Randomization

X

       

 Allocation

 

X

      

Interventions:

 RT

  

X

     

 Concurrent TMZ

  

X

     

 Adjuvant TMZ

   

X

X

   

Assessments:

 Physical examination

 

X

   

Every 3 months

Every 6 months

Annually

 KPS

 

X

 

X

 

Every 3 months

Every 6 months

Annually

 CBC

 

X

Weekly

X

Weekly

   

 Serum biochemistry

 

X

Weekly

X

Weekly

   

 Postoperative head MRI

X

  

X

 

Every 3 months

Every 6 months

Annually

 Cognitive function

X

  

X

 

Every 3 months

Every 6 months

Annually

 Adverse events

  

X

X

X

Every 3 months

Every 6 months

Annually

  1. Abbreviations: RT radiation therapy, TMZ temozolomide, KPS Karnofsky performance score, CBC complete blood count, MRI magnetic resonance imaging
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Trials

ISSN: 1745-6215