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Table 2 Schedule of assessments for Arm 1 patients

From: DICE: Dual mTorc Inhibition in advanCed/recurrent Epithelial ovarian cancer resistant to standard treatment—a study protocol for a randomised trial investigating a novel therapy called TAK228

Time-point →

Assessments ↓

Each treatment cycle

End of treatment visit

Follow-up

Day 1

Day 8

Day 15

30 days post last treatment (±5 days)

Every 3 months (±5 days)

Vital signs

X

X

X

X

 

ECOG Performance Status

X

X

X

X

 

Physical examination

X

X

X

X

 

Haematology

X

X

X

X

 

Biochemistry

X

X

X

X

 

Urinalysis

X

 

X

Cycles 1 and 2 only

X

 

Pregnancy test

X

  

X

 

Research blood sample for ctDNA

X

  

X

 

Radiological imaging assessment (CT with contrast/MRI chest, abdomen and pelvis)

Every 2 cycles/8 weeks (± 7 days)

X

X

CA125

X

  

X

X

Paclitaxel administration

X

X

X

  

Quality of Life Questionnaires (EORTC QLQ-C30 and EORTC QLQ-OV28)

X

  

X

 

Adverse events (NCI CTCAE version 4.03)

X

X

X

X

X

Concomitant medications

X

X

X

X

 

Record of further treatment

    

X

Record of overall survival

    

X