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Intensification Treatment of Ovarian Cancer by PIPAC
Sponsor: Moscow Regional Oncological Dispensary
Summary
The goal of this clinical trial is to learn whether repeated cisplatin-based PIPAC added to standard TC chemotherapy can improve outcomes in women aged 18-75 years with newly diagnosed FIGO IIIB-IIIC epithelial ovarian cancer and visually detectable peritoneal carcinomatosis. The main questions are whether repeated PIPAC increases the rate of complete surgical cytoreduction (CRS R0) and whether it improves disease control, survival outcomes, and safety compared with standard combined treatment including a single PIPAC procedure. Participants will undergo screening, intraoperative randomization, systemic chemotherapy, PIPAC procedures according to study arm, interval cytoreductive surgery, protocol-specified postoperative treatment if needed, and regular follow-up assessments.
Official title: Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) as a Component of Combined Treatment in Patients With Advanced Epithelial Ovarian Cancer and Peritoneal Carcinomatosis: A Randomized Phase II Trial (PrimPIPAC)
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2025-04-02
Completion Date
2030-04-02
Last Updated
2026-04-07
Healthy Volunteers
No
Interventions
PIPAC
Performed laparoscopically under general anesthesia. Drug: cisplatin 30 mg/m² diluted in 180 mL normal saline Administration: * Capnoperitoneum established with carbon dioxide at a target pressure of 12-14 mmHg. * Flow settings depend on nozzle size: No. 150, 0.3-0.4 mL/s; No. 200, 0.7-0.8 mL/s. * Nebulizer selection depends on patient height and body-mass index; tense ascites is evacuated before treatment. * The aerosol flow is directed toward the largest free intraperitoneal space and away from hollow viscera, ligated vessels, and tumor beds. * Exposure time is maintained for exactly 30 minutes. * The abdomen is decompressed without aspirating the cytostatic solution, and no drain is left in place.
Locations (1)
Moscow Regional Oncological Dispensary
Balashikha, Russia