Before inclusion within 28 days before drug initiation | During treatment (1 cycle = 28 days) | End of treatment 30 days after the last dose of study treatment (+/− 7 days) | Follow-up every 3 months up to progression | Overall survival after disease progression | ||||||
---|---|---|---|---|---|---|---|---|---|---|
Cycle 1 | Cycle 2 | Other Cycles from cycle 2 | Additional Assessment at D1C4 and every 3 cycles (D1C7, D1C10 …) (within 7 days) | |||||||
D1 | D15 | D1 | D15 | D1 | ||||||
Study drug administration | CABOZANTINIB treatment (in a 28 day-cycle) | |||||||||
Informed Consent should be done before any study procedures | ✓ | No study visit is required. The following treatment is at the discretion of physician | ||||||||
Clinical assessment - Complete physical examination including gynecological examination, weight, height (only at baseline), ECOG, vital signs - Adverse Events collection and concomitant treatments | ✓ | ✓ | ✓ ✓ | ✓ ✓ | ✓ ✓ | ✓ ✓ | ✓ ✓ | ✓ ✓ | ||
Laboratory Assessments1 - Blood assessment - Urinary assessment | ✓ within 14 days before drug initiation | ✓3 | ✓ within 3 days | ✓ within 3 days | ✓ within 3 days | ✓ within 3 days | ✓ within 3 days | ✓ within 3 days | ||
Cardiac assessment - ECG (QT interval) - Cardiac Echography or MUGA | ✓ ✓ | ✓ | ✓ | |||||||
Quality-of-life assessment EORTC QLQ-C30 / CX24 | ✓ | ✓ | ✓ | |||||||
Diary card | ✓4 | ✓ | ✓ | |||||||
Radiological assessment - CT-scan (thorax, abdominal and pelvis) 6 - Pelvic MRI 2 | ✓ ✓ | within 3 days ✓ ✓ | +/− 7 days ✓ ✓ | +/− 14 days ✓ ✓ | ||||||
Biological collections - Tumoral biopsy optional5 - Blood samples | ✓ ✓ | ✓ | ✓ | ✓at progression |