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Table 1 Overview of visits and interventions

From: PerSurge (NOA-30) phase II trial of perampanel treatment around surgery in patients with progressive glioblastoma

Study period

Enrolment

Treatment period (60 ± 3 days)

Post-treatment follow-up

Screening/Baseline

Safety

follow up

OS & PFS

follow-up

Visit no.

1

2

3

4

5

6

7

FU

Timeline/Timepoint

D0

D16

(± 2)

0–3 days

prior

resection

D30

(± 3)

tumour resection

0–3

days

after resection

POD30

(± 3)

EOT visit

4 weeks

after last dose

(EOT visit)

Every

3 months

Mode of scheduled visit

Outpatient/inpatient

Outpatient/inpatient

Outpatient/inpatient

Inpatient

Outpatient/inpatient

Outpatient/inpatient

Outpatient/inpatient

Outpatient/

tel. visit

Written Informed Consenta

X

       

In-/Exclusion Criteria

X

       

Demographics, medical and surgical history/ preexisting conditions (evaluated in analogy to CTCAE)

X

       

Randomisation*

X

       

Vital signsb

X

 

X

  

X

X

 

Physical and neurological examination

X

X

X

 

X

X

X

 

Concomitant medications/procedures

X

X

X

X

X

X

X

Xc

Karnofsky Performance Status Scale

X

X

X

 

X

X

X

 

Mini Mental State Examination

X

    

X

  

HRQoL: Patient questionnaires EORTC QLQ-C30, QLQ-BN20

X

    

X

  

Adverse Events

 

X

X

X

X

X

X

 

Documentation of epileptic seizures

Xd

X

X

 

X

X

X

 

Intervention

        

Dispensing of trial druge

X

X

X

 

X

   

Return of trial drug

 

X

X

 

X

X

  

Study drug compliance checkf

 

X

X

X

X

X

  

Tumour (MRI) and response assessment

        

Gd-MRI (volumetric assessment of tumour sample)g

X

X

X

 

X

X

  

Progression (RANO criteria, imaging-based)

 

X

X

 

X

X

X (if MRI performed, according to local standards)

Xh

Survival status

 

X

X

X

X

X

X

Xh

Laboratory evaluations

        

Haematology

Xi

 

X

 

X

 

X

 

Clinical chemistry

Xi

 

X

 

X

 

X

 

Pregnancy test

X

 

X

  

X

  

Asservation of tumour materialj, assessment of connectivity score

   

X

    

Serum perampanel concentrationk,+

   

X

    

Serum for exploratory biomarkers for network connectivity +

X

  

X

 

X

  

Cerebrospinal fluid (CSF)l,+

X

  

X

    

Plasma (Determination of extracellular vesicles)+

   

X

    
  1. Bold font means assessment for derivation of one of the two primary efficacy outcomes. Tumour resection is no trial-specific procedure and no component of the intervention
  2. *All baseline characteristics (including vital signs, laboratory data, medical history, prior medication,…) must be assessed before randomisation
  3. +Exploratory/Translational research (not part of the main trial)
  4. aWritten informed consent can be obtained up to 7 days prior to randomisation, but before any study-specific intervention/assessment
  5. bVital signs: blood pressure, pulse rate, temperature
  6. cIn long-term FU only subsequent anticancer therapies will be documented
  7. dBased on the last 4 weeks
  8. eExperimental/ control intervention: capsules once daily before going to bed (weekly increases up to 1 × 5 capsules / day)
  9. fTreatment adherence (check of patient’s dosing diary and the counting of the number of returned capsules) at every study visit
  10. gGadolinium Magnetic Resonance Imaging; Day 0 (-4 days): reference MRI; Day 16 (± 2 days): “safety MRI” to detect patients who need earlier resection (before day 30 post-randomisation) according to the assessment of the local investigator
  11. hProgression determined by the investigator according to RANO without central review [AI-based]) by the BIRC, and survival status during long-term follow-up will be determined for every patient by phone interviews or by e-mail or regular patient follow-up documentations at the respective site every 3 months until last patient out
  12. iUp to 7 days prior to randomisation as part of routine laboratory analyses
  13. jRelapse tumour resection 30 [28,29,30,31,32,33,34] days after Day 0. Tissue asservation should take place 10–18 h after last study drug intake: [1] fresh frozen, [2] FFPE, [3] 4% PFA; for measurement of perampanel tissue levels and study drug-dependent tumour tissue effects. On the day prior to surgical tumour removal, the exact time of intake of trial medication has to be documented
  14. kSerum sample (Perampanel) is taken 10–14 h after last study drug intake
  15. lAt baseline, CSF is collected by lumbar puncture in a suitable plastic tube. On the day of surgery, CSF can be collected intraoperatively or by lumbar puncture
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BMC Cancer

ISSN: 1471-2407

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