GERCOR - Multidisciplinary Oncology Cooperative Group
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).
Age
18–75
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | Two Therapeutic Strategies in First-line in Patients With Epithelial Advanced Ovarian Cancer
