Table 1 Schedule of assessments for screening (all patients)
Time-point → Assessments ↓ | Screening/baseline | |
|---|---|---|
Within 28 days | Within 14 days | |
Informed consent | X | |
Inclusion/exclusion criteria | X | |
Demographics | X | |
Medical History | X | |
German sites only: screening for HIV and hepatitis | X | |
Vital signs | X | |
ECOG Performance Status | X | |
Complete physical examination | X | |
12-lead echocardiogram (ECG) | X | |
Haematology | X | |
Biochemistry | X | |
Coagulation | X | |
Fasting serum glucose | X | |
Glycosylated haemoglobin (HbA1c) | X | |
Fasting lipid profile | X | |
Urinalysis | X | |
Creatinine clearance based on Cockcroft-Gault estimate, Wright Formula or urine collection | X | |
Blood serum pregnancy test | X | |
Research blood sample for genomic DNA | X | |
Archival tumour tissue | X | |
Radiological imaging assessment (CT with contrast/MRI chest, abdomen and pelvis) | X | |
CA125 | X | |
Research fresh tumour biopsy, if judged technically feasible by radiologist, unless the local site is unable to collect the sample due to COVID-19 capacity restrictions | X | |
Quality of Life Questionnaires (EORTC QLQ-C30 and EORTC QLQ-OV28) | X | |
Adverse events (NCI CTCAE version 4.03) | X | |
Concomitant medications | X | |
Randomisation | X | |