Intensification Treatment of Ovarian Cancer by PIPAC
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)
Moscow Regional Oncological Dispensary
160 participants
Apr 2, 2025
INTERVENTIONAL
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.
Eligibility
Inclusion Criteria6
- Female, age 18-75 years.
- Histologically verified ovarian cancer with peritoneal carcinomatosis.
- FIGO stage IIIB or IIIC.
- visually detectable peritoneal carcinomatosis.
- Peritoneal metastatic involvement documented preoperatively by ultrasound, CT, MRI, PET-CT, or equivalent imaging.
- Ability to comply with protocol procedures and provide written informed consent.
Exclusion Criteria9
- Age > 75 years; ECOG 3-4; cachexia with BMI <= 16.
- Severe concomitant disease in exacerbation or decompensation.
- Extra-abdominal metastases, including metastatic pleuritis.
- Mucinous ovarian carcinoma or another active malignant neoplasm, except malignancies in clinical remission for more than 2 years.
- Pronounced adhesive disease of the abdominal cavity.
- Pregnancy or breastfeeding.
- Positive BRCA1 or BRCA2 status.
- Any condition precluding safe PIPAC or protocol execution, including hollow-organ perforation, gastrointestinal resection with anastomosis, or repair of a hollow-viscus defect.
- Refusal of treatment at any study stage.
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Interventions
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)
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NCT07514494