CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian advanced cancer.
Histologically confirmed advanced (FIGO stage III or IV) invasive epithelial ovarian cancer, primary peritoneal cancer, or fallopian-tube cancer. Pleural cytology has to be performed in patients with pleural effusion.
Initial intervention : debulking surgery or diagnostic surgery in the 3 weeks before inclusion
Age ≥18 and < 75 years old.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 before surgery (ECOG ≤ 1 and Lee score < 6 in patients > 70 years old).
FIGO stage IV extra-abdominal disease, with the exception of lymph nodes and pleural invasion.
Patient having received previous chemotherapy for ovarian cancer.
Left ventricular ejection fraction < 50% before chemotherapy initiation
Other invasive cancer in the past 5 years (baso- and spinocellular cutaneous carcinoma with complete resection are accepted)
Parallel
CC0 - Carboplatin (IV) - Paclitaxel (IV)
Drug(6 cycles)
CC0 - Cisplatin (IP) - Epirubicin (IV)
Drug(6 cycles)
CC>0 - Carboplatin (IV)- Paclitaxel (IV)
Drug* carboplatin (IV) - paclitaxel (IV) (3 cycles) * Interval surgery * Carboplatin (IV) - paclitaxel (IV) (3 cycles)
CC>0 - Cisplatin (IP/IV)- Epirubicin (IV)
Drug* Cisplatin (IV) - Epirubicin (IV) (3 cycles) * Interval surgery : * if CC0: Cisplatin (IP) - Epirubicin (IV) (3 cycles) * if CC\>0 Cisplatin (IV)- Epirubicin (IV) (3 cycles)
Pathological complete peritoneal response (pCR)
Interval debulking surgery or final evaluation peritoneal surgery
Quality of life (QLQ -C30) assessment
Quality of life (QLQ-OV28) assessment
IPSS score
Number of patients with treatment-related adverse events as assessed by CTCAE version 4.03
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Groupe Hospitalier Diaconesses Croix Saint-Simon
Lead sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Collaborator
