Comparing Two First-Line Treatment Approaches for Advanced Epithelial Ovarian Cancer Intraperitoneal Chemotherapy vs Total Intravenous Chemotherapy

What this Trial Is About

Researchers are investigating the best first-line treatment strategy for women with advanced epithelial ovarian cancer. This randomized phase II study compares two therapeutic approaches following initial surgery, based on the completeness of tumor removal. The study is conducted across multiple centers to evaluate which strategy may lead to better outcomes for patients with this condition. Participants receive either a combination of carboplatin and paclitaxel chemotherapy given intravenously with surgery, or a combination of cisplatin and epirubicin chemotherapy with surgery. Cisplatin is administered intraperitoneally if no visible tumor remains after surgery, otherwise intravenously. The treatment includes six cycles of chemotherapy every three weeks, and in some cases, a second surgery during treatment if there is remaining disease and an operable response. Throughout the study, participants will be monitored for pathological complete peritoneal response over two years, quality of life assessments at multiple points, and treatment-related side effects. Long-term outcomes such as event-free survival and overall survival will be evaluated at five and ten years. The study involves regular assessments including surgical responses and patient-reported outcomes, with careful safety monitoring during and after treatment.

Two Therapeutic Strategies in First-line in Patients With Epithelial Advanced Ovarian Cancer