Phase II Trial of Cisplatin-Based PIPAC Added to Standard Chemotherapy for Women With Advanced Ovarian Cancer and Peritoneal Carcinomatosis Evaluating Repeated Versus Single PIPAC Procedures Alongside Surgery and Chemotherapy

What this Trial Is About

Researchers are evaluating whether adding repeated cisplatin-based pressurized intraperitoneal aerosol chemotherapy PIPAC to standard taxane and platinum TC chemotherapy improves outcomes in women aged 18 to 75 years with advanced epithelial ovarian cancer and visible peritoneal carcinomatosis FIGO stages IIIB-IIIC. The study aims to determine if repeated PIPAC increases the rate of complete surgical tumor removal and improves disease control, survival, and safety compared to standard treatment that includes only one PIPAC procedure. This phase II randomized trial also explores the best way to combine PIPAC with systemic chemotherapy and surgery for this condition. Participants are randomly assigned to one of two groups one group receives multiple PIPAC procedures integrated with systemic TC chemotherapy and interval cytoreductive surgery, while the other group receives systemic chemotherapy, surgery, and only a single PIPAC treatment during surgery. In cases where complete tumor removal is not achieved, a crossover treatment includes additional PIPAC after surgery with further chemotherapy. PIPAC is delivered laparoscopically under general anesthesia using cisplatin aerosolized into the abdominal cavity under controlled pressure and flow. Throughout the study, participants undergo diagnostic laparoscopy, biopsies, repeated clinical and laboratory assessments, imaging, tumor marker tests, and monitoring for side effects. The main outcome is the rate of complete surgical tumor removal assessed about 9 to 12 weeks after randomization. Secondary outcomes include survival, disease progression, tumor marker response, ascites control, adverse events, and wound healing. Follow-up continues for up to two years with assessments of cancer control and quality of life. Safety measures are in place to protect patients and staff during PIPAC procedures.

Intensification Treatment of Ovarian Cancer by PIPAC