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
Groupe Hospitalier Diaconesses Croix Saint-Simon
84 participants
Oct 1, 2016
INTERVENTIONAL
Conditions
Summary
CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian advanced cancer.
Eligibility
Inclusion Criteria8
- 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 Criteria8
- 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
Interventions
(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)
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03025477