Title
Two Therapeutic Strategies in First-line in Patients With Epithelial Advanced Ovarian Cancer
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
Phase
Phase 2Lead Sponsor
Groupe Hospitalier Diaconesses Croix Saint SimonStudy Type
InterventionalStatus
RecruitingIndication/Condition
Ovarian Cancer, EpithelialIntervention/Treatment
paclitaxel epirubicin carboplatin cisplatin ...Study Participants
84CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian advanced cancer.
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).
(6 cycles)
(6 cycles)
carboplatin (IV) - paclitaxel (IV) (3 cycles) Interval surgery Carboplatin (IV) - paclitaxel (IV) (3 cycles)
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)
Initial or interval surgery associated with 6 cycles of chemotherapy in intravenous (IV) of carboplatin and paclitaxel. The regimen of administration of the chemotherapy is as following: Carboplatin AUC 6 - IV - Day (D) 1 Paclitaxel 80mg / m² - IV - D1, D8, D15 one cycle every 3 weeks
Initial or interval surgery associated with 6 cycles of chemotherapy of cisplatin and epirubicin. Cisplatin is administrated in intraperitoneal (IP) if no macroscopic residual tumor at the end of the intervention (initial or interval). If evidence of macroscopic residual tumor, cisplatin is administered in IV. Epirubicin is always given in IV. Second cytoreduction surgery at mid-term of chemotherapy cycles, only in patients operable in response after 3 cycles and with persistent residual disease after initial surgery or incomplete initial staging. The regimen of administration of the chemotherapy is as following: Cisplatin 80mg / m² - IV or IP - D1 Epirubicin 60mg / m² - IV - D3 one Cycle every 3 weeks.
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
