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 |