CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian advanced cancer.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Pathological complete peritoneal response (pCR) — 2-year Interval debulking surgery or final evaluation peritoneal surgery
Trial sites (7)
Facility
City
Region
Status
Centre Georges François Leclerc
Dijon
France
Recruiting
Institut Hospitalier Franco-Britannique
Levallois-Perret
France
Recruiting
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris
France
Recruiting
Hôpital Saint Antoine
Paris
France
Recruiting
Hôpital Poissy Saint Germain
Poissy
France
Recruiting
CHU Poitiers
Poitiers
France
Recruiting
Centre Hospitalier Senlis
Senlis
France
Recruiting
More Groupe Hospitalier Diaconesses Croix Saint-Simon trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.