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Table 3 ARISTOCRAT trial schedule of events

From: A randomised phase II trial of temozolomide with or without cannabinoids in patients with recurrent glioblastoma (ARISTOCRAT): protocol for a multi-centre, double-blind, placebo-controlled trial

Activity

Screening

Within 21 days of

trial entry

Randomisation

Week 0#

Cycle 1

Week 4

Cycle 2

± 3 days

Week 8

Cycle 3

± 3 days

Week 10

± 3 days

Week 12

Cycle 4

± 3 days

Week 16

Cycle 5

± 3 days

Week 20

Cycle 6

± 3 days

Week 22

± 3 days

Week 24

EOT

Follow Up

Week 28

Week 30

As per SoC

Informed consent1

X

             

Confirm eligibility

X

             

MRI scan (RANO criteria)2

X

    

X

   

X

  

X

X

Minimum 3 monthly

Blood tests3

X

 

X

X

X

 

X

X

X

 

X

   

Concomitant medication4

X

 

X

X

X

 

X

X

X

 

X

X

 

X

Electrocardiogram5

X

             

Karnofsky Performance Status6

X

 

X

X

X

 

X

X

X

 

X

X

 

X

Medical history7

X

             

Physical examination8

X

 

X

X

X

 

X

X

X

 

X

   

Pregnancy test9

X

 

X

X

X

 

X

X

X

 

X

   

Urine test for cannabinoid use10

  

X

 

X

     

X

   

Vital signs11

X

 

X

X

X

 

X

X

X

 

X

   

TMZ + nabiximols/placebo12

  

X

X

X

 

X

X

X

     

Adverse Events13

X

X

X

X

 

X

X

X

 

X

X

 

X

Patient diary

 

X

X

X

 

X

X

X

     

Health-Related Quality of Life14

 

X

 

X

  

X

  

X

   

Survival status14

 

X

X

X

 

X

X

X

 

X

X

 

X

  1. # Patients must start trial treatment within 28 days of randomisation
  2. 1 Written informed consent must be obtained before any trial procedures occur and no greater than 21 days of before randomisation
  3. 2 Brain MRI scan is ideally performed within 21 days of randomisation. If MRI scan has not been performed within 28 days of start of cycle 1, this will need to be repeated. During trial treatment and follow up, scans must be performed ± 3 days of the scheduled visit
  4. 3 Blood tests to include: Full blood count (to include Absolute Neutrophil Count and platelets count), urea and electrolytes, liver function tests. During trial treatment, should be performed within 14 days prior to Cycle 1 and within 3 days of Cycles 2–6
  5. 4 Review of concomitant medication to include dexamethasone and anti-epileptic use
  6. 5 Single echocardiogram to be performed at Screening only
  7. 6 Karnofsky Performance Status to be used
  8. 7 Pseudonymised copy of local pathology report for first diagnosis of GBM must be sent to the ARISTOCRAT Trial Office
  9. 8 Physical examination to include central and peripheral nervous system examination, required at baseline and subsequently if clinically indicated
  10. 9 Females of childbearing potential will require a negative pregnancy test (serum or urine) within 7 days prior to randomisationand within 3 days of Cycles 1-6 during treatment.
  11. 10 Urine sample for cannabinoid use on week 0 (Cycle 1) to be collected pre-dose
  12. 11 Vital signs to include blood pressure, heart rate, height (screening only) and weight
  13. 12 Temozolomide (TMZ): 150mg/2 for Cycle 1, increasing to 200mg/m2 for Cycles 2–6, once daily for days 1–5 at the start of each 28-day cycle
  14. 13 Adverse Events (AEs) to be documented and reported until the end of treatment visit. During follow up, AEs to be reviewed by Investigator but do not need to be recorded on the AE Form
  15. 14 HRQoL questionnaires to be completed in clinic at defined visits. HRQoL questionnaires on Week 0 (Cycle 1) to be completed pre-dose
  16. 15 Follow up visits and assessment will continue until a minimum of 52 weeks from the start of trial treatment or until death, whichever is sooner, as part of standard of care visits. To include documentation of additional hospital or GP visits at follow up visits
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BMC Cancer

ISSN: 1471-2407

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