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Randomized Study Assessing Two Strategies of First Line: a Strategy With Intraperitoneal Chemotherapy and a Strategy With Total Intravenous Strategy, in Patients With Epithelial Advanced Ovarian Cancer (NCT03025477)

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
          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
          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).

          7 locations

          France (7)
          • Centre Georges François Leclerc
            recruiting
            Dijon, France
          • Institut Hospitalier Franco-Britannique
            recruiting
            Levallois-Perret, France
          • Groupe Hospitalier Diaconesses Croix Saint Simon
            recruiting
            Paris, France
          • Hôpital Saint Antoine
            recruiting
            Paris, France
          • Hôpital Poissy Saint Germain
            recruiting
            Poissy, France
          • CHU Poitiers
            recruiting
            Poitiers, France
          • Centre Hospitalier Senlis
            recruiting
            Senlis, France
          Status:
          recruiting
          Type:
          Interventional
          Phase:
          Start:
          30 September, 2016
          Updated:
          20 November, 2017
          Participants:
          84
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