Phase
Condition
Ovarian Cysts
Treatment
Retarded IDS (Interval Debulking Surgery)
Standard IDS (Interval Debulking Surgery)
Clinical Study ID
Ages 18-99 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Female patients ≥18 years.
Histologically confirmed epithelial ovarian cancer, fallopian tube carcinoma orprimary peritoneal carcinoma, high grade serous or endometrioïd, with the exceptionof mucinous, clear cell and carcinosarcoma histologies.
Performance status < 2 (see Appendix 2).
Documented International Federation of Gynecologic Oncology (FIGO 2014, Appendix 1)stage IIIB-IIIC-IVa unsuitable for complete primary cytoreductive surgery (confirmedby open laparoscopy or by laparotomy [not mandatory for stage IVA]).
Patient must be judged resectable after 3 courses of Neoadjuvant chemotherapy
Adequate bone marrow, liver and renal function to receive chemotherapy andsubsequently to undergo surgery:
White blood cells (WBC) >3x109/L, absolute neutrophil count (ANC) ≥1,5x109/L,platelets (PLT) ≥100x109/L, hemoglobin (Hb) ≥9 g/dL,
Serum creatinine <1.25 x upper normal limit (UNL) or creatinine clearance ≥ 30mL/min according to Cockroft-Gault formula or to local lab measurement, serumbilirubin <1.25 x UNL, AST(SGOT) and ALT(SGPT) <2.5 x UNL.
Signed informed consent obtained prior to any study-specific procedures.
Patient affiliated to, or a beneficiary of, a social security category
Exclusion
Exclusion Criteria:
Mucinous, clear cell , carcinosarcoma and low grade serous carcinomahistologies.
Synchronous or previous other malignancies within 3 years prior to starting studytreatment, with the exception of adequately treated non-melanomatous skin cancer orcarcinoma in situ (of the cervix or breast or other sites).
Patients with brain metastases, seizure not controlled with standard medicaltherapy, or history of cerebrovascular accident (CVA, stroke) or transient ischemicattack (TIA) or subarachnoid hemorrhage before 6 months from the enrollment on thisstudy.
Any other concurrent medical conditions contraindicating surgery or chemotherapythat could compromise the adherence to the protocol (including but not limited toimpaired cardiac function or clinically significant cardiac diseases, active oruncontrolled infections, HIV-positive patients on antiretroviral therapy,uncontrolled diabetes, cirrhosis, chronic active or persistent hepatitis, impairedrespiratory function requiring oxygen-dependence, serious psychiatric disorders).
Pregnant or breastfeeding women.
Study Design
Connect with a study center
ICO Paul Papin
Angers, 49055
FranceSite Not Available
ICA - Polyclinique Urbain V
Avignon, 84000
FranceSite Not Available
Hôpital de Beauvais
Beauvais, 60000
FranceSite Not Available
Institut Bergonié
Bordeau, 33076
FranceSite Not Available
CHU de BREST - Hôpital Cavale Blanche
Brest, 29200
FranceSite Not Available
Hôpital Morvan - Centre Hospitalier Universitaire
Brest, 29200
FranceActive - Recruiting
Centre François Baclesse
Caen, 14000
FranceSite Not Available
Centre Hospitalier Universitaire Caen
Caen, 14033
FranceSite Not Available
Centre Jean Perrin
Clermont-ferrand, 63000
FranceSite Not Available
Centre Georges François Leclerc
Dijon, 21079
FranceSite Not Available
Hôpital Simone Veil
Eaubonne, 95602
FranceSite Not Available
CHU Grenoble-Alpes - Site Nord (La Tronche)
Grenoble, 38043
FranceSite Not Available
Centre Jean Bernard - Clinique Victor Hugo
Le Mans, 72000
FranceSite Not Available
CHU de Limoges - Hôpital de la Mère et de l'Enfant
Limoges, 87000
FranceSite Not Available
Hôpital du Scorff
Lorient, 56100
FranceSite Not Available
Centre Léon Bérard
Lyon, 69373
FranceSite Not Available
Hôpital Saint-Joseph
Marseille, 13008
FranceSite Not Available
ICM Val d'Aurelle
Montpellier, 34298
FranceSite Not Available
Centre Hospitalier Universitaire de Nantes-Hôpital Mère et Enfant
Nantes, 44093
FranceSite Not Available
Hôpital Privé du Confluent
Nantes, 44202
FranceSite Not Available
Clinique Hartmann
Neuilly-sur-seine, 92200
FranceSite Not Available
Centre Antoine Lacassagne
Nice, 06189
FranceSite Not Available
Groupe Hospitalier Pitié Salpétrière
Paris, 75651
FranceSite Not Available
Hôpital Cochin
Paris, 75014
FranceSite Not Available
Hôpital Européen Georges Pompidou
Paris, 75015
FranceSite Not Available
Hôpital Tenon
Paris, 75970
FranceActive - Recruiting
HCL - Centre Hospitalier Lyon Sud
Pierre-benite, 69495
FranceSite Not Available
Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021
FranceSite Not Available
Institut Jean Godinot
Reims, 51056
FranceSite Not Available
CHU de Rennes - Hôpital Sud
Rennes, 35203
FranceSite Not Available
Hôpitaux Drôme Nord - Site de Romans-sur-Isère
Romans-sur-Isère, 26100
FranceSite Not Available
Hôpital René Huguenin, Institut Curie
Saint-cloud, 92210
FranceSite Not Available
ICO Centre René Gauducheau
Saint-herblain, 44805
FranceSite Not Available
Clinique Médico-chirurgicale CHARCOT
Sainte Foy-les-Lyon, 69110
FranceSite Not Available
Hôpital de Hautepierre
Strasbourg, 67098
FranceSite Not Available
Institut Claudius Regaud
Toulouse, 31059
FranceSite Not Available
Centre Hospitalier Universitaire Bretonneau
Tours, 37000
FranceSite Not Available
Gustave Roussy
Villejuif, 94805
FranceSite Not Available
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