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Table 1 Intervention and assessment schedule for the GRIPS trial

From: Glioblastoma radiotherapy using Intensity modulated Radiotherapy (IMRT) or proton Radiotherapy—GRIPS Trial (Glioblastoma Radiotherapy via IMRT or Proton BeamS): a study protocol for a multicenter, prospective, open-label, randomized, two-arm, phase III study

 

Inclusion examination

RT

Examination after RT

V1: 4 weeks after RT

V2: month 4

V3: month 7

V4: month 10

V5: month 13

V6: month 16

V7: month 19

V8: month 22

V9: month 25

Screening

x

           

CRF form

x

 

x

x

x

x

x

x

x

x

x

x

QLQ-C30 und QLQ-BN20

x

 

x

 

x

  

x

    

Hopkins Verbal Learning Test-

Revised

x

 

x

 

x

  

x

    

Symptoms/ Toxicity according to CTCAE

x

 

x

x

x

x

x

x

x

x

x

x

MRI

xa

  

x

x

x

x

x

x

x

x

x

RT

 

x

          

Additional scientific program

x

 

x

x

x

       
  1. RT = radiotherapy
  2. Screening: includes check of inclusion and exclusion criteria, taking of medical history including surgical and pathological report, medical examination and randomization
  3. a MRI less than 4 weeks old, if older at time of inclusion, a new MRI for planning is mandatory