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Two Therapeutic Strategies in First-line in Patients With Epithelial Advanced Ovarian Cancer

RECRUITINGPhase 2Sponsored by Groupe Hospitalier Diaconesses Croix Saint-Simon
Actively Recruiting
PhasePhase 2
SponsorGroupe Hospitalier Diaconesses Croix Saint-Simon
Started2016-10
Est. completion2021-10
Eligibility
Age18 Years – 75 Years
SexFEMALE
Healthy vol.Accepted

Summary

CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian advanced cancer.

Eligibility

Age: 18 Years – 75 YearsSex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Conditions2

CancerOvarian Cancer, Epithelial

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