Ovarian Cancer, Epithelial
Groupe Hospitalier Diaconesses Croix Saint-Simon
GERCOR - Multidisciplinary Oncology Cooperative Group
CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian advanced cancer.
- Drug: CC0 - Carboplatin (IV) - Paclitaxel (IV)(6 cycles)
- Drug: CC0 - Cisplatin (IP) - Epirubicin (IV)(6 cycles)
- Drug: CC>0 - Carboplatin (IV)- Paclitaxel (IV)carboplatin (IV) - paclitaxel (IV) (3 cycles) Interval surgery Carboplatin (IV) - paclitaxel (IV) (3 cycles)
- Drug: CC>0 - Cisplatin (IP/IV)- Epirubicin (IV)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)
|Ages eligible for Study||18 Years to 75 Years|
|Genders eligible for Study||Female|
|Accepts Healthy Volunteers||No|
- 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).
- Adequate blood count (test realized in the past 14 days before inclusion) : neutrophils > 1500/mm3, platelets > 150 000/mm3.
- Creatinine clearance MDRD ≥ 60 mL/min
- Registration in a national health care system (CMU included).
- Signed and dated informed consent.
- 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)
- Concomitant administration of prophylactic phenytoin or live attenuated viral vaccines such as yellow fever vaccine,
- Patients with known hypersensitivity to any component of study drug
- Patients without motivation or capacity to respect study requirements and constraints
- Pregnancy or breast feeding women
This is a randomized phase II study, open-label and multicentric. After initial intervention (debulking surgery or diagnostic surgery) patient will randomized in the study according to Completeness of cytoreduction (CC) score (CC0 or CC>1).
- Centre Georges François LeclercrecruitingDijon, France
- Institut Hospitalier Franco-BritanniquerecruitingLevallois-Perret, France
- Groupe Hospitalier Diaconesses Croix Saint SimonrecruitingParis, France
- Hôpital Saint AntoinerecruitingParis, France
- Hôpital Poissy Saint GermainrecruitingPoissy, France
- CHU PoitiersrecruitingPoitiers, France
- Centre Hospitalier SenlisrecruitingSenlis, France
30 September, 2016
20 November, 2017